Effects of a 12-Week mHealth Program on FunctionalCapacity and Physical Activity in Patients With PeripheralArtery Disease. SUPERvised exercise therapy or immediate PTA for intermittent claudication in patients with an iliac artery obstruction--a multicentre randomised controlled trial; SUPER study design and rationale. The effect of supervised exercise and cilostazol on coagulation and fibrinolysis in intermittent claudication: a randomized controlled trial. The influence of a long term exercise program on lower limb movement variability and walking performance in patients with peripheral arterial disease. Improvement of the walking ability in intermittent claudication due to superficial femoral artery occlusion with supervised exercise and pneumatic foot and calf compression: a randomised controlled trial. Treatment efficacy of intermittent claudication by invasive therapy, supervised physical exercise training compared to no treatment in unselected randomised patients II: one-year results of health-related quality of life. Effective training for patients with intermittent claudication A non-randomised controlled trial of the clinical and cost effectiveness of a Supervised Exercise Programme for claudication. Evaluation of patient compliance, quality of life impact and cost-effectiveness of a "test in-train out" exercise-based rehabilitation program for patients with intermittent claudication. Does supervised exercise offer adjuvant benefit over exercise advice alone for the treatment of intermittent claudication? A randomised trial. Effects of a long-term exercise program on lower limb mobility, physiological responses, walking performance, and physical activity levels in patients with peripheral arterial disease. The vascular nurse in practice: Results of prescribed exercise training in patients with intermittent claudication. Increasing exercise tolerance of persons limited by claudication pain using polestriding. Effects of a 6-month exercise program pilot study on walking economy, peak physiological characteristics, and walking performance in patients with peripheral arterial disease The constitutive procoagulant and hypofibrinolytic state in patients with intermittent claudication due to infrainguinal disease significantly improves with percutaneous transluminal balloon angioplasty. The effect of supervised exercise therapy on physical activity and ambulatory activities in patients with intermittent claudication. Gender differences following supervised exercise therapy in patients with intermittent claudication. Local Versus Systemic Mechanisms Underlying Supervised Exercise Training for Intermittent Claudication Long-term effects of structured home-based exercise program on functional capacity and quality of life in patients with intermittent claudication. Supervised exercise, stent revascularization, or medical therapy for claudication due to aortoiliac peripheral artery disease: the CLEVER study. A randomised controlled trial of supervised exercise regimens and their impact on walking performance, skeletal muscle mass and calpain activity in patients with intermittent claudication. Nordic pole walking improves walking capacity in patients with intermittent claudication: a randomized controlled trial The HAAPI (Home Arm Assistance Progression Initiative) Trial Effects of Task-Specific Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke: Results of the STEPS Randomized Clinical Trial Effects of home versus supervised exercise for patients with intermittent claudication. Exercise training improves functional status in patients with peripheral arterial disease. Impact of a supervised strength training or walking training over a subsequent unsupervised therapy period on walking capacity in patients with claudication. Influence of the Physical Training on Muscle Function and Walking Distance in Symptomatic Peripheral Arterial Disease in Elderly Cost-effectiveness of exercise therapy in patients with intermittent claudication: supervised exercise therapy versus a 'go home and walk' advice. Cost-effectiveness of endovascular revascularization compared to supervised hospital-based exercise training in patients with intermittent claudication: a randomized controlled trial. Multicenter randomized clinical trial of supervised exercise therapy with or without feedback versus walking advice for intermittent claudication. The ischemic window: a method for the objective quantitation of the training effect in exercise therapy for intermittent claudication. Supervised Exercise Versus Primary Stenting for Claudication Resulting From Aortoiliac Peripheral Artery Disease: Six-Month Outcomes From the Claudication Exercise Versus Endoluminal Revascularization (CLEVER) Study
Supervised exercise is beneficial for peripheral artery disease ( PAD ) patients limited by intermittent claudication ( IC ) . However , supervised exercise for PAD remains widely underutilized . Mobile health ( mHealth ) provides an intermediate solution between supervised and independent home-based exercise . The purpose of this study was to determine the effects on functional capacity and physical activity patterns of a 12-week mHealth program in PAD patients with IC . Twenty patients were r and omized into  usual care or a 12-week mHealth intervention consisting of patient education , smartphones , and physical activity trackers . Patient education was disseminated through smartphone and a daily exercise prescription was given based on steps per day . Primary outcomes were 12-week changes in peak VO2 and claudication onset time ; and changes in physical activity measured by steps per/day and minutes of exercise per/week . mHealth patients significantly increased peak VO2 from 15.2 ± 4.3 to 18.0 ± 4.8 ml/kg/min ( 20.3 ± 26.4 % ; p ≤0.05 ) , while usual care did not change from 14.3 ± 5.4 to 14.5 ± 5.7 ml/kg/min ( 1.0 ± 6.9 % ; NS ) . Comparison of these changes result ed in a significant difference between groups ( p ≤0.05 ) for peak VO2 . Claudication onset time significantly increased in mHealth ( 320 ± 226 to 525 ± 252 seconds ; ≤ 0.05 ) , while usual care demonstrated a worsening ( 252 ± 256 to 231 ± 196 seconds ; NS ) . The comparison of these group changes result ed in a significant difference ( p ≤0.05 ) . Neither steps per day or minutes of activity reached significant differences between groups . In conclusion , a 12-week mHealth program in PAD patients with IC  can improve peak VO2 and claudication onset time ; and mHealth interventions represent a promising alternative therapy for those patients who can not participate in supervised exercise INTRODUCTION Treatment of intermittent claudication ( IC ) due to peripheral arterial disease ( PAD ) is aim ed at improving walking distance and includes secondary prevention of cardiovascular disease . Both supervised exercise therapy ( SET ) and percutaneous transluminal angioplasty ( PTA ) have proven to be effective in increasing maximum and pain-free walking distance in IC . However , the optimal treatment strategy in patients with IC due to iliac artery stenosis or occlusion remains unclear . OBJECTIVE To compare the ( cost- ) effectiveness of initial PTA versus initial SET in patients with disabling IC due to an iliac artery obstruction . DESIGN In a multicentre r and omised controlled trial 400 consecutive patients with IC will be r and omly assigned to PTA ( with additional stent placement on indication ) or SET . Primary outcomes are maximum walking distance and health-related quality of life measured using the disease-specific VascuQol instrument after 1 year . Secondary outcomes are pain-free walking distance , functional status , generic quality of life , complications related to each of the interventions , additional interventions , treatment failures and costs ( cost-effectiveness and cost-utility ) after 1 year . CONCLUSION AND IMPLICATION S Based on the results of this proposed large study well-founded adjustments of existing guidelines on the treatment of iliac artery occlusive disease can be implemented ( Clinical Trials.gov NCT01385774 ; Nederl and s Trial Register NTR2776 ) BACKGROUND The prothrombotic , hypofibrinolytic state that develops in patients with intermittent claudication ( IC ) upon walking due to ischemia-reperfusion injury ( IRI ) of the leg muscles may contribute to the high incidence of life- and limb-threatening thrombotic events observed in this patient group . Treatments , such as angioplasty , that obtund the IRI also ameliorate the procoagulant diathesis . The effect on this diathesis of supervised exercise and cilostazol , both of which provide symptomatic benefit in IC , but without significantly obtunding IRI , is unknown . METHODS Thirty-four patients ( 27 men and 7 women ; median age , 67 years ; range , 63 - 72 years ) were r and omized to receive best medical therapy ( BMT ) plus supervised exercise ( n = 9 ) , BMT plus cilostazol ( n = 9 ) , BMT plus supervised exercise plus cilostazol ( n = 7 ) , or BMT alone ( n = 9 ) in a 2 x 2 factorial design . Thrombin-antithrombin complex and prothrombin fragments 1 and 2 , both markers of thrombin generation ; plasminogen activator inhibitor antigen and tissue plasminogen activator antigen , both markers of fibrinolysis ; ankle-brachial pressure index ( ABPI ) ; and initial and absolute claudication distance ( ACD ) were measured at baseline and then 3 and 6 months after r and omization . RESULTS At 6 months , when compared with receiving BMT only , supervised exercise and cilostazol result ed in improvements in ABPI of 18 % and 13 % and in ACD of 40 % and 64 % , respectively . The effects on ABPI and ACD of combining supervised exercise and cilostazol were additive . Supervised exercise , cilostazol , and supervised exercise combined with cilostazol had no significant effect on any of the four hemostatic markers . CONCLUSIONS Treatment of IC by supervised exercise or cilostazol results in significant improvements in ABPI and ACD but has no demonstrable effect on the prothrombotic diathesis . This suggests that supervised exercise and cilostazol , unlike angioplasty , are unlikely to have a long-term beneficial effect on the thrombotic risks faced by these patients The purpose of this study was to examine the effects of a 12month exercise program on lower limb movement variability in patients with peripheral arterial disease ( PAD ) . Participants ( n=21 ) with an appropriate history of PAD and intermittent claudication ( IC ) volunteered for this study and were r and omly allocated to either a control group ( CPAD-IC ) ( n=11 ) , which received normal medical therapy and a treatment group ( TPAD-IC ) ( n=10 ) , which received normal medical therapy treatment and a 12month supervised exercise program . All participants underwent 2D joint angular kinematic analysis during normal walking to assess lower limb movement variability and walking speed . Between-group differences were analyzed via mixed measures ANOVA . The 12month supervised exercise program made no significant impact on the lower limb movement variability or walking speed of the TPAD-IC group as determined by either intralimb joint coordination or single joint analysis techniques . Long term supervised exercise programs do not appear to influence the lower limb movement variability of PAD-IC patients OBJECTIVES To compare the effect of unsupervised exercise , supervised exercise and intermittent pneumatic foot and calf compression ( IPC ) on the claudication distance , lower limb arterial haemodynamics and quality of life of patients with intermittent claudication . METHODS Thirty-four eligible patients with stable intermittent claudication were r and omised to IPC ( n = 13 , 3h/d for 6 months ) , supervised exercise ( n = 12 , three hourly sessions/week for 6 months ) or unsupervised exercise ( n = 9 ) . In each patient , initial claudication distance ( ICD ) , absolute claudication distance ( ACD ) , resting ankle brachial pressure index ( ABPI ) , and resting hyperaemic calf arterial inflow were measured before , 6 weeks , 6 months and 1 year after r and omisation . Quality of life was assessed with the short form (SF)-36 , walking impairment ( WIQ ) and intermittent claudication question naires ( ICQ ) . RESULTS Compared with unsupervised exercise , both IPC and supervised exercise , increased ICD and ACD , up to 2.83 times . IPC  increased arterial inflow ( p < 0.05 at 6 weeks ) and ABPI .  Supervised exercise decreased arterial inflow and increased ABPI ( p < 0.05 at 6 months ) . Unsupervised exercise had no effect on arterial inflow or ABPI . IPC improved significantly the ICQ score and the speed score of the WIQ , while supervised exercise improved the WIQ claudication severity score . At 1 year clinical effectiveness of supervised exercise and IPC was largely preserved . CONCLUSIONS IPC , by augmenting leg perfusion , achieved improvement in walking distance comparable with supervised exercise . Long-term results in a larger number of patients will provide valuable information on the optimal treatment modality of intermittent claudication OBJECTIVE to compare the effectiveness of invasive therapy , supervised physical training and no treatment in terms of health-related quality of life ( HRQL ) in patients with intermittent claudication ( IC ) . DESIGN a prospect i ve , r and omised , controlled study . MATERIAL S a total of 253 unselected patients with stable IC were sequentially r and omised into 3 balanced treatment groups . At 1 year follow-up data from a battery of generic and disease specific HRQL question naires , and global indices of quality of life and physical condition were available in 171 patients . RESULTS compared with a non-diseased reference group , claudicants were substantially limited in daily physical functioning , but little affected regarding emotional , cognitive and social functioning , or well-being .  Invasive therapy yielded significantly greater improvements in some aspects of physical functioning and walk-related symptoms than training . Training was not superior to invasive therapy on any HRQL dimension and superior to no treatment on only one dimension . Treatment effects , however , were generally small-to-moderate and levels of physical dysfunction in all groups remained higher than reference values . CONCLUSIONS invasive therapy is more effective than supervised training in alleviating illness-specific symptoms and improving certain aspects of physical functioning - the primary HRQL domains impacted on by IC and the principal goals of its treatment . However , since treatment effect sizes were at most moderate and given that untreated claudicants reported at most small deterioration in HRQL , the level of evidence supporting invasive therapy is modest Objective . Current guidelines for treatment of intermittent claudication ( IC ) do not include a specific recommendation for the intensity of exercise therapy . Thus , the purpose of this study was to determine the relative effectiveness of high versus low intensity exercise for patients with IC , and further to study the effect of such training on blood flow to the legs during exercise . Design . The effect of eight weeks of supervised endurance training was examined in 16 patients with IC . The patients were r and omly assigned to training at intensities corresponding to either 60 % or 80 % of their peak oxygen consumption ( VO2peak ) , respectively . Results . VO2peak and time to exhaustion increased significantly ( 9 % and 16 % , respectively ) more in the high intensity group ( p<0.05 ) . Blood flow to the legs did not change after training in any of the groups . Conclusion . High intensity training gave larger improvements in VO2peak and time to exhaustion than low intensity training . As blood flow did not change after the exercise program , it is likely that the observed different increase of VO2peak was due to changed mitochondrial oxidative capacity and /or skeletal muscle diffusive capacity OBJECTIVES The main aims of treatment in patients with intermittent claudication ( IC ) are to improve the clinical indicators of lower limb ischaemia and patients ' quality of life ( QoL ) . The aims of this study were assess the clinical and cost effectiveness of a supervised exercise programme ( SEP ) in patients with IC . DESIGN Non-r and omised , controlled trial . SETTING University teaching hospital . PATIENTS AND METHODS Two groups of patients with IC were studied . Seventy patients were sequentially recruited before and after the establishment of a Supervised Exercise Programme at our unit . Thirty-seven patients ( median age 69 years , 26 men ) received  conservative medical therapy ( CMT ) and 33 patients ( median age 67 years , 22 men ) received CMT plus a 3 month SEP of graduated physical exercise for sixty minutes , three times each week . Patients were assessed prior to and at 6 months following treatment . At each assessment patient reported walking distances ( PRWD ) , treadmill claudication and maximal distances ( ICD and MWD ) , ankle brachial pressure indices ( ABPI ) pre & post exercise and patient reported QoL using the SF36 question naire were assessed . RESULTS Prior to intervention the two groups were well matched . Following treatment , CMT patients demonstrated no significant change in PRWD or ICD but did record a small but significant improvement in MWD .  CMT was also associated with a negative effect size in the SF36 index and in 7 of the 8 SF36 QoL domains , effect size > -0.5 for the domains of Physical Function and Emotional Role . SEP patients demonstrated significant improvement in PRWD , ICD and MWD . SEP was associated with a positive effect size in the SF36 index and in 2 SF36 QoL domains but a negative effect size in a further 2 domains . However , all QoL effect sizes following SEP were < + /-0.5 . Intergroup differences in effect sizes were > 0.5 for the SF36 domains of Physical Function , Physical Role , Emotion Role and SF36 index . SEP result ed in a 0.027 quality adjusted life year ( QALY ) gain over CMT in the first year post-treatment thus the cost/QALY gained of SEP is pound1780 at 1 year . CONCLUSIONS Compared to CMT , SEP increases walking distances , improves QoL and is a highly cost-effective treatment for IC BACKGROUND Patients with intermittent claudication ( IC ) could benefit from low-cost , effective rehabilitative programs . This retrospective study evaluates compliance , impact on Quality of Life ( QoL ) and cost-effectiveness of a hospital prescribed , at-home performed ( Test-in/Train-out ) rehabilitative program for patients with IC . METHODS AND RESULTS Two-hundred and eighty-nine patients with IC ( 71 ± 10.1 years , M = 210 ) were enrolled for a 2-year period .  Two daily 10-min home walking sessions at maximal asymptomatic speed were prescribed , with serial check-ups at the hospital . Compliance with the program was assessed by assigning a score of 1 ( lowest compliance ) to 4 ( highest compliance ) . The SF-36 question naire and a constant-load treadmill test  were used to evaluate QoL and Initial/Absolute Claudication Distance , respectively . Both direct and indirect costs of the program were considered for cost-effectiveness analysis . Two-hundred and fifty patients ( 70.5 ± 9.2 years , M = 191 ) , at Fontaine 's II-B stage ( 86 % ) , were included in the study . No adverse events were reported . The average compliance score was 3.1 . At discharge , both SF-36 domains and walking performance significantly increased ( P < 0.0001 ) . A total of 1,839 in-hospital check-ups ( 7.36 /patient ) were performed . Direct and indirect costs represented 93 % and 7 % of the total costs , respectively . The average costs of a visit and of a therapy cycle were C68.93 and C507.20 , respectively . The cost to walk an additional meter before stopping was C9.22 . CONCLUSIONS A Test-in/Train-out program provided favourable patient compliance , QoL impact and cost-effectiveness in patients with IC OBJECTIVE Exercise advice is the main treatment for symptom relief in the UK for patients with mild to moderate Intermittent Claudication ( IC ) . Would a weekly exercise and motivation class for 6 months offer adjuvant benefit over written and verbal exercise advice alone ? PATIENTS AND METHODS Fifty-nine patients attending a regional vascular centre for whom IC was the main factor affecting mobility were r and omised to either exercise advice alone ( n=30 ) or exercise advice with a once a week 45 min supervised exercise/motivation class ( n=29 ) . The mean age was 68 years . Baseline and 6-month assessment included a Quality of Life Question naire -- the Short-Form-36 , the Charing Cross Symptom Specific Claudication Question naire ( CCCQ ) and treadmill walking distance ( 3.5 km/h 12 % ) . RESULTS At 6-month follow-up the supervised exercise group had improved their treadmill walking by 129 % compared to 69 % in the advice alone group ( p=0.001 ) . This significant improvement was maintained at the subsequent 9 and 12-month follow-up assessment s. By the 9-month stage the advice only group CCCQ score had improved 16 % from baseline , while the supervised exercise group had a significantly better 43 % improvement in base line score ( p<0.05 ) . Self reported frequency of walks was higher in the exercise class group being significant for improvement in CCCQ score . CONCLUSION A weekly , supervised exercise and motivation class for a 6-month period provides a significant improvement in patients ' symptoms , quality of life , and distance walked compared with advice alone and this improvement continues after attendance at class has ceased OBJECTIVE The purpose of the study was to examine the effects of a 12-month exercise program on lower limb mobility ( temporal-spatial gait parameters and gait kinematics ) , walking performance , peak physiological responses , and physical activity levels in individuals with symptoms of intermittent claudication due to peripheral arterial disease ( PAD-IC ) . METHODS Participants ( n = 21 ) with an appropriate history of PAD-IC , ankle-brachial pressure index ( ABI ) < 0.9 in at least one leg and a positive Edinburgh claudication question naire response were prospect ively recruited . Participants were r and omly allocated to either a control PAD-IC group ( CPAD-IC )  ( n = 11 ) that received st and ard medical therapy and a treatment PAD-IC group ( TPAD-IC ) ( n = 10 ) , which also took part in a 12-month supervised exercise program . A further group of participants ( n = 11 ) free of PAD ( ABI > 0.9 ) and who were non-regular exercisers were recruited from the community to act as age and mass matched controls ( CON ) . Lower limb mobility was determined via two-dimensional video motion analysis . A grade d treadmill test was used to assess walking performance and peak physiological responses to exercise . Physical activity levels were measured via a 7-day pedometer recording . Differences between groups were analyzed via repeated measures analysis of variance ( ANOVA ) . RESULTS The 12-month supervised exercise program had no significant effect on lower limb mobility , peak physiological responses , or physical activity levels in TPAD-IC compared with CPAD-IC participants . However , the TPAD-IC participants demonstrated significantly greater walking performance ( 171 % improvement in pain free walking time and 120 % improvement in maximal walking time compared with baseline ) . CONCLUSION The results of this study confirm that a 12-month supervised exercise program will result in improved walking performance , but does not have an impact on lower limb mobility , peak physiological responses , or physical activity levels of PAD-IC patients Intermittent claudication ( IC ) is a mild stage of peripheral arterial disease that affects between 3 % and 7 % of the population and up to 1 in 5 patients over the age of 75 years . Risk factors such as hypertension , hyperlipidemia , diabetes , smoking , and genetics increase the incidence of peripheral arterial disease . Patients with IC have limitations in functional capacity and can benefit from regular exercise . Walking is the preferred mode of exercise and improves the symptoms of claudication in several ways . Vascular nurses can play an important role during exercise therapy . A personalized , home-based exercise program can be developed , and nurses can assist and motivate patients during follow-up periods . Helping patients to quit smoking and control other risk-factor modifications ( ie , high blood pressure and lipid levels ) also has high priority in daily practice of the vascular nurse . This prospect i ve study will illustrate the results of prescribed home-based exercise training by a vascular nurse on the maximum painless walking distance for patients with IC and will be applied to subgroups of vascular pathology OBJECTIVE The efficacy of polestriding exercise ( walking with modified ski poles with a movement pattern similar to cross-country skiing ) to increase exercise tolerance of persons with intermittent claudication pain caused by peripheral arterial disease was tested in this 24-week prospect i ve r and omized clinical trial . METHODS The study was conducted in a Department of Veterans Affairs Hospital with 52 individuals who gave written informed consent and were r and omized into either a polestriding exercise ( n = 27 ; age , 65.5 + /- 7.0 years ; ankle brachial index , 0.64 + /- 0.25 ) or nonexercise control ( n = 25 ; age , 68.6 + /- 8.9 years ; ankle brachial index , 0.69 + /- 0.14 ) group ( P > .05 for all comparisons ) . The polestriding exercise program consisted of supervised training three times per week for 4 weeks , two times per week for 8 weeks , one time per week for 4 weeks , biweekly for 4 weeks and unsupervised training for 4 weeks . Starting in week 5 , subjects took their poles home with instructions to repeat the most recent supervised training walk at an appropriate and convenient location near their residence . This was referred to as unsupervised but directed exercise . Subjects were provided with a personal log book for documenting unsupervised exercise sessions . With both supervised and unsupervised exercise , subjects were expected to complete a total of four 30-minute to 45-minute polestriding exercise sessions per week . The main outcome measures were exercise duration on symptom-limited incremental treadmill test , Walking Impairment Question naire , rating of perceived leg pain at baseline , 4 , 8 , 12 , 16 , and 24 weeks , and constant work-rate treadmill exercise tests at baseline and at 4 , 12 , and 24 weeks . RESULTS Polestriding significantly ( P < .001 ) improved exercise tolerance on the constant work-rate and incremental treadmill tests . Ratings of perceived claudication pain were significantly less after the polestriding training program .  Subject perceived distance and walking speed scores on the Walking Impairment Question naire improved in the polestriding trained group only ( P < .001 and .022 , respectively ) . CONCLUSION This r and omized clinical trial provides empirical evidence that 24 weeks of polestriding training significantly improves quantitative and qualitative measures of the exercise tolerance of persons limited by intermittent claudication pain The purpose of this study was to examine the effects of a 6-month exercise program on submaximal walking economy in individuals with peripheral arterial disease and intermittent claudication ( PAD-IC ) . Participants ( n = 16 ) were r and omly allocated to either a control PAD-IC group ( CPAD-IC , n = 6 ) which received st and ard medical therapy , or a treatment PAD-IC group ( TPAD-IC ;  n = 10 ) which took part in a supervised exercise program . During a grade d treadmill test , physiological responses , including oxygen consumption , were assessed to calculate walking economy during submaximal and maximal walking performance . Differences between groups at baseline and post-intervention were analyzed via Kruskal – Wallis tests . At baseline , CPAD-IC and TPAD-IC groups demonstrated similar walking performance and physiological responses . Postintervention , TPAD-IC patients demonstrated significantly lower oxygen consumption during the grade d exercise test , and greater maximal walking performance compared to CPAD-IC . These preliminary results indicate that 6 months of regular exercise improves both submaximal walking economy and maximal walking performance , without significant changes in maximal walking economy . Enhanced walking economy may contribute to physiological efficiency , which in turn may improve walking performance as demonstrated by PAD-IC patients following regular exercise programs BACKGROUND Patients with intermittent lower limb claudication ( IC ) exhibit a prothrombotic diathesis that is acutely exacerbated by exercise . This may occur because of ischemia/reperfusion injury within the leg muscles during walking and may contribute to the increased risk of thrombotic vascular events in this group of patients . This r and omized study compared the effect of lower limb revascularization by percutaneous transluminal balloon angioplasty ( PTA ) , supervised exercise , and best medical therapy ( BMT ) alone on this prothrombotic state . METHODS Twenty-three patients ( 16 men and 7 women ; median age , 67 years ; range , 57 - 77 years ) with IC due to infrainguinal disease were r and omized to receive BMT alone ( n = 7 ) , BMT plus PTA ( n = 9 ) , or BMT plus supervised exercise ( n = 7 ) as part of the Health Technology Assessment -funded EXercise vs Angioplasty in Claudication Trial ( EXACT ) . Patients were assessed at baseline and at 3 and 6 months . Thrombin-antithrombin complex ( TAT ) was determined as a marker of thrombin generation , and plasminogen activator inhibitor ( PAI ) antigen was determined as a marker of fibrinolysis . Increased TAT indicates a procoagulant state , and increased PAI antigen indicates a hypofibrinolytic state . RESULTS At 6 months , subjects r and omized to BMT plus PTA demonstrated a significant improvement in ankle-brachial pressure index ( P = .013 ) and maximal walking distance ( P = .008 ) , a significant decline in resting thrombin generation ( median [ interquartile range ] TAT , 6.4 microg/L [ 2.7 - 13.5 microg/L ] to 1.5 microg/L [ 0.3 - 2.9 microg/L ] ; P = .038 ) , and an improvement in resting fibrinolysis ( median [ interquartile range ] PAI-1 , 10.0 ng/mL [ 1.0 - 20.5 ng/mL ] to 1.0 ng/mL [ 1.0 - 14.8 ng/mL ] ; P = .043 ) . There was no significant change in any of these parameters in patients r and omized to BMT plus supervised exercise or to BMT alone . CONCLUSIONS The addition of lower limb revascularization by PTA to BMT in patients with IC due to infra-inguinal disease results in a medium-term improvement in the resting procoagulant and hypofibrinolytic state . This may translate into a reduction in morbidity and mortality from thrombotic vascular events in this group of patients OBJECTIVE / BACKGROUND Intermittent claudication ( IC ) is associated with a reduction in physical activity ( PA ) and a more rapid functional decline leading to a higher mortality rate compared with healthy individuals . Supervised exercise therapy ( SET ) is known to increase the walking capacity of patients with IC . However , it is unclear whether SET increases PA . The aim of this study was to investigate the effect of SET on PA levels and ambulatory activities in patients with IC . METHODS Patients newly diagnosed with IC were requested to wear an activity monitor 1 week prior to and 1 week immediately after 3 months of SET . The primary outcome was the percentage of patients meeting the minimum recommendations of PA ( American College of Sports Medicine [ACSM]/American Heart Association [ AHA ] recommendation for public health of ≥ 67 metabolic equivalents [METs]/min/day , in bouts of ≥ 10 min ) at baseline and after 3 months of SET . Additionally , daily PA level ( METs/min ) , duration of ambulatory activities , daily number of steps , pain free walking distance ( PFWD ) , maximal walking distance ( MWD ) , and Short Form Health Survey ( SF-36 ) health surveys were compared before and after SET . RESULTS Data from 41 participants were available for analysis . A higher number of participants met the ACSM minimum recommendation for PA at the 3 month follow up ( baseline : 43 % ; 3 months : 63 % ; p = .003 ) . Despite significant increases in PFWD ( baseline : 210 m ; 3 months : 390 m ; p = .001 ) , MWD ( baseline : 373 m ; 3 months : 555 m ; p = .002 ) and physical functioning score ( SF-36 )  following SET , no increase in the mean daily PA level was found ( 395 ± 220 vs. 411 ± 228 METs/min ; p = .43 ) . Furthermore , the total number of steps and time spent in ambulatory activities did not change following SET . CONCLUSION Three months of SET for IC leads to more patients meeting the ACSM/AHA public health minimum recommendations for PA . Assessment of PA could be incorporated as an outcome parameter in future research comparing different treatment modalities for peripheral arterial disease OBJECTIVE Prevalence of peripheral arterial disease is equal in men and women . However , women seem to suffer more from the burden of disease . Current studies on gender-related outcomes following supervised exercise therapy ( SET ) for intermittent claudication ( IC ) yield conflicting results . METHODS A follow-up analysis was performed on data from the 2010 Exercise Therapy in Peripheral Arterial Disease ( EXITPAD ) study , a multicenter r and omized controlled trial including IC patients receiving SET or a walking advice .  The SET program was supervised by physiotherapists and included interval-based treadmill walking approximating maximal pain combined with activities such as cycling and rowing . Patients usually started with three 30-minute sessions a week . Training frequency was adapted during the following year on the basis of individual needs . The primary outcome was gender differences regarding the change in absolute claudication distance ( ACD ) after SET . ACD was defined as the number of meters that a patient had covered just before he or she was forced to stop walking because of intolerable pain . Secondary outcomes were gender differences in change of functional walking distance , quality of life , and walking (dis)ability after SET . Walking distances were obtained by  st and ardized treadmill testing  according to the Gardner-Skinner protocol . Quality of life was measured by the 36-Item Short Form Health Survey , and walking (dis)ability was determined by the Walking Impairment Question naire ( WIQ ) . Measurements were performed at baseline and after 3 , 6 , 9 , and 12 months . Only patients who met the 12-month follow-up measure were included in the analysis . RESULTS A total of 113 men and 56 women were available for analysis . At baseline , groups were similar in terms of clinical characteristics and ACD walking distances ( men , 250 meters ; women , 270 meters ; P = .45 ) . ACD improved for both sexes . However , ACD increase was significantly lower for women than for men during the first 3 months of SET ( Δ 280 meters for men vs Δ 220 meters for women ; P = .04 ) . Moreover , absolute walking distance was significantly shorter for women compared with men after 1 year ( 565 meters vs 660 meters ; P = .032 ) . Women also reported less on several WIQ subdomains , although total WIQ score was similar ( 0.69 for men vs 0.61 for women ; P = .592 ) . No differences in quality of life  after SET were observed . CONCLUSIONS Women with IC benefit less during the first 3 months of SET and have lower absolute walking distances  after 12 months of follow-up compared with men . More research is needed to determine whether gender-based IC treatment strategies are required The mechanisms by which exercise training improves intermittent claudication remain unclear . In this article , the effects of local and systemic physiological factors on improved exercise tolerance after a supervised exercise program in claudicants are investigated . A total of 60 patients were r and omized to 3 months of supervised exercise followed by 3 months of unsupervised exercise , or to exercise advice alone ( control ) . Supervised exercise increased both pain-free and maximal walking distances . Heart rate during submaximal exercise and resting mean arterial pressure were lower after supervised exercise at 6 months . Serum lactate at maximum claudication increased significantly after 3 months in the supervised exercise group but this change had resolved by 6 months . Symptomatic improvement was accompanied by modest reductions in mean arterial pressure and submaximal heart rate on exercise . Increased serum lactate at maximum claudication subsequently declined despite continued improvement in walking distance , suggesting local adaptations to improve efficiency of muscle oxygen delivery and /or utilization OBJECTIVES To evaluate effects of a structured home-based exercise program on functional capacity and quality of life ( QoL ) in patients with intermittent claudication ( IC ) after 1-year follow-up , and to compare these results with those from a concurrent control group who received supervised exercise training ( SET ) . DESIGN Comparative longitudinal cohort study . SETTING Referral center . PARTICIPANTS Patients ( N=142 ) with IC . INTERVENTIONS Structured home-based exercise training or SET . MAIN OUTCOME MEASURES The maximum ( pain-free ) walking distance and the ankle-brachial index ( ABI ) ( at rest and postexercise ) were measured at baseline and after 6 and 12 months ' follow-up . Additionally , QoL was evaluated using a self-administered question naire consisting of the Euroqol-5D ( scale 0 - 1 ) , rating scale ( scale 0 - 100 ) , Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ; scale 0 - 100 ) , and the Vascular Quality of Life Question naire ( VascuQol ; scale 1 - 7 ) . Comparison of the groups was performed with adjustment for the nonr and omized setting using propensity scoring . RESULTS One hundred forty-two patients with IC started the  structured home-based exercise program , of whom 95 ( 67 % ) completed 12 months ' follow-up . The mean relative improvement compared with baseline was statistically significant after 12 months ' follow-up for the maximum and pain-free walking distance ( 342 % , 95 % confidence interval [ CI ] , 169 - 516 ; P<.01 and 338 % , 95 % CI , 42 - 635 ; P=.03 , respectively ) and for the ABI postexercise ( mean change , .06 ; 95 % CI , .01-.10 ; P=.02 ) . For the QoL outcomes , the improvement compared with baseline was statistically significant after 12 months for the VascuQol ( mean change , .42 ; 95 % CI , .20-.65 ; P<.01 ) and for the SF-36 physical functioning ( mean change , 5.17 ; 95 % CI , .77 - 9.56 ; P=.02 ) . Compared with the structured home-based exercise program , patients in the control group showed significantly better results in the mean relative improvement of maximum and pain-free walking distance and change in the ABI at rest after 12 months ' follow-up . CONCLUSIONS Structured home-based exercise training is effective in improving both functional capacity and QoL in patients with IC and may be considered as a feasible and valuable alternative toSET , since supervised exercise programs are not often available BACKGROUND Treatment for claudication that is due to aortoiliac peripheral artery disease ( PAD ) often relies on stent revascularization ( ST ) . However , supervised exercise ( SE ) is known to provide comparable short-term ( 6-month ) improvements in functional status and quality of life . Longer-term outcomes are not known . OBJECTIVES The goal of this study was to report the longer-term ( 18-month ) efficacy of SE compared with ST and optimal medical care ( OMC ) . METHODS Of 111 patients with aortoiliac PAD r and omly assigned to receive OMC , OMC plus SE , or OMC plus ST , 79 completed the 18-month clinical and treadmill follow-up assessment . SE consisted of 6 months of SE and an additional year of telephone-based exercise counseling . Primary clinical outcomes included objective treadmill-based walking performance and subjective quality of life . RESULTS Peak walking time improved from baseline to 18 months for both SE ( 5.0 ± 5.4 min ) and ST ( 3.2 ± 4.7 min ) significantly more than for OMC ( 0.2 ± 2.1 min ; p < 0.001 and p = 0.04 , respectively ) . The difference between SE and ST was not significant ( p = 0.16 ) . Improvement in claudication onset time was greater for SE compared with OMC , but not for ST compared with OMC . Many disease-specific quality -of-life scales demonstrated durable improvements that were greater for ST compared with SE or OMC . CONCLUSIONS Both SE and ST had better 18-month outcomes than OMC . SE and ST provided comparable durable improvement in functional status and in quality of life up to 18 months . The durability of claudication exercise interventions merits its consideration as a primary PAD claudication treatment OBJECTIVES Supervised exercise training ( SET ) is recommended for patients with intermittent claudication ( IC ) . The optimal exercise programme has not been identified , and the potential adverse effects of exercise on these patients warrant consideration . Calpain proteases have been linked with tissue atrophy following ischaemia-reperfusion injury . High calpain activity may therefore cause muscle wasting in claudicants undergoing SET , and skeletal muscle mass ( SMM ) is integral to healthy ageing . This study assesses the impact of ( 1 ) treadmill-based SET alone ; and ( 2 ) treadmill-based SET combined with resistance training on pain-free walking distance ( PFWD ) , SMM , and calpain activity . METHODS Thirty-five patients with IC were r and omised to 12 weeks of treadmill only SET ( group A ) , or combined treadmill and lower-limb resistance SET ( group B ) . PFWD via a 6-minute walking test , SMM via dual energy X-ray absorptiometry , and calpain activity via biopsies of gastrocnemius muscles were analysed . RESULTS Intention-to-treat analyses revealed PFWD improved within group A ( 160 m to 204 m , p = .03 ) , but not group B ( 181 m to 188 m , p = .82 ) . There was no between group difference ( p = .42 ) . Calpain activity increased within group A ( 1.62 × 10(5 ) fluorescent units [ FU ] to 2.21 × 10(5 ) FU , p = .05 ) , but not group B. There was no between group difference ( p = .09 ) . SMM decreased within group A ( -250 g , p = .11 ) and increased in group B ( 210 g , p = .38 ) ( p = .10 between groups ) . Similar trends were evident for per protocol analyses , but , additionally , change in SMM was significantly different between groups ( p = .04 ) . CONCLUSIONS Neither exercise regimen was superior in terms of walking performance . Further work is required to investigate the impact of the calpain system on SMM in claudicants undertaking SET Abstract Purpose : The aim of the study was to compare the efficacy of Nordic pole walking ( NPW ) training with traditional treadmill training ( TT ) on a claudication ( CD ) and maximum walking distance ( MWD ) in patients with peripheral arterial disease ( PAD ) . Method : Patients with intermittent claudication ( IC ) ( n = 70 ; age=68.27 ) in the Fontaine class II were r and omized into a two three-month rehabilitation programs performed three times per week . TT were finished by 31 patients , NPW by 21 . Walking capacity was measured by an  exercise treadmill test ( ETT ) with the Gardner – Skinner protocol ( before and after the program ) and  six minute walk test ( 6MWT ) ( before , during and after the program ) . Results : In an ETT both groups reached significant increase in CD and MWD ( p ≤ 0.005 ) . In 6MWT NPW group reached significant increase in both CD ( p = 0.001 ) and MWD ( p = 0.001 ) , whereas the TT group only in MWD ( p = 0.001 ) . Conclusions : NPW has been shown to be as effective as the st and ard TT and is much less expensive . It should be the preferred method of exercise for PAD patients with IC . Implication s for Rehabilitation Nordic walking training is a valuable form of rehabilitation for peripheral arterial disease ( PAD ) patients with intermittent claudication ( IC ) . Nordic walking has been shown to be as efficient as traditional treadmill training . It is however more cost-effective method of rehabilitation in PAD patients Background . Geographical location , socioeconomic status , and logistics surrounding transportation impede access of poststroke individuals to comprehensive rehabilitative services . Robotic therapy may enhance telerehabilitation by delivering consistent and state-of-the art therapy while allowing remote monitoring and adjusting therapy for underserved population s.  The H and Mentor Pro ( HMP ) was incorporated within a home exercise program ( HEP ) to improve upper-extremity ( UE ) functional capabilities poststroke . Objective . To determine the efficacy of a home-based telemonitored robotic-assisted therapy as part of a HEP compared with a dose-matched HEP-only intervention among individuals less than 6 months poststroke and characterized as underserved . Methods . In this prospect i ve , single-blinded , multisite , r and omized controlled trial , 99 hemiparetic participants with limited access to UE rehabilitation were r and omized to either ( 1 ) the experimental group , which received combined HEP and HMP for 3 h/d ×5 days ×8 weeks , or ( 2 ) the control group , which received HEP only at an identical dosage . Weekly communication between the supervising therapist and participant promoted compliance and progression of the HEP and HMP prescription . The Action Research Arm Test and Wolf Motor Function Test along with the Fugl-Meyer Assessment ( UE ) were primary and secondary outcome measures , respectively , undertaken before and after the interventions . Results . Both groups demonstrated improvement across all UE outcomes . Conclusions . Robotic + HEP and HEP only were both effectively delivered remotely . There was no difference between groups in change in motor function over time . Additional research is necessary to determine the appropriate dosage of HMP and HEP Background and Purpose : A phase II , single-blinded , r and omized clinical trial was conducted to determine the effects of combined task-specific and lower-extremity ( LE ) strength training to improve walking ability after stroke . Subjects : The participants were 80 adults who were ambulatory 4 months to 5 years after a unilateral stroke . Method : The exercise interventions consisted of body-weight – supported treadmill training ( BWSTT ) , limb-loaded resistive leg cycling ( CYCLE ) , LE muscle-specific progressive-resistive exercise ( LE-EX ) , and upper-extremity ergometry ( UE-EX ) . After baseline assessment s , participants were r and omly assigned to a combined exercise program that included an exercise pair . The exercise pairs were : BWSTT/UE-EX , CYCLE/UE-EX , BWSTT/CYCLE , and BWSTT/LE-EX . Exercise sessions were 4 times per week for 6 weeks ( total of 24 sessions ) , with exercise type completed on alternate days . Outcomes were self-selected walking speed , fast walking speed , and 6-minute walk distance measured before and after intervention and at a 6-month follow-up . Results : The BWSTT/UE-EX group had significantly greater walking speed increases compared with the CYCLE/UE-EX group ; both groups improved in distance walked . All BWSTT groups increased walking speed and distance whether BWSTT was combined with LE strength training or not . Discussion and Conclusion : After chronic stroke , task-specific training during treadmill walking with body-weight support is more effective in improving walking speed and maintaining these gains at 6 months than resisted leg cycling alone . Consistent with the overtraining literature , LE strength training alternated daily with BWSTT walking did not provide an added benefit to walking outcomes PURPOSE This study was performed to test the efficacy of a supervised , hospital-based exercise program compared with a home-based exercise program involving minimal supervision , for both walking ability and quality of life measures in patients with exercise-limiting intermittent leg claudication . METHODS Twenty-one patients were assigned r and omly to 12 weeks of supervised exercise or to a home-based exercise group . After 12 weeks the participants in the supervised group transitioned to a home-based program . Both groups were then reevaluated at the end of 24 weeks . The initial claudication distance ( ICD ) and absolute claudication distance ( ACD ) on progressive treadmill exercise was measured at baseline , 12 weeks , and 24 weeks . Additionally , self-reported quality of life status was evaluated using the MOS SF-36 question naire . RESULTS Each group improved ( P < 0.01 ) ACD from baseline to 12 weeks , which was sustained at the 24-week follow-up . Both groups experienced similar long-term improvements ( P < 0.05 ) in ACD ( 521.5 + /- 253.4 meters to 741.9 + /- 365.6 meters for the supervised group , 532.2 + /- 263.5 meters to 715.0 + /- 394.4 meters in the home group , P not significant , between groups ) . The supervised group experienced a greater improvement ( P < 0.01 ) in the ICD after 12 weeks than the home group but not at 24 weeks . The on-site group also experienced significant improvements in ICD after 24 weeks ( P < 0.05 ) . Neither group manifested an improvement in self-reported physical function or mental health as assessed by the MOS SF-36 . CONCLUSION A structured exercise program was more effective in improving the ICD over a 24-week period than a less formal , home-based program . However , if patients are screened properly and receive adequate instruction , a home-based program can be a safe , low-cost alternative providing similar long-term ( 24 weeks ) exercise benefits in ACD PURPOSE In patients with intermittent claudication ( IC ) a structured walking exercise program improves exercise performance . However , few studies have evaluated the effects of exercise training on functional status during daily activities . We hypothesized that a supervised exercise training program would improve functional status in patients with IC , with 24 weeks of training more beneficial than 12 weeks . A secondary aim was to evaluate the effects of strength training and combinations of strength and treadmill training on functional status . METHODS Twenty-nine men with disabling IC were r and omized to 12 weeks of either supervised treadmill training ( 3 hr/wk at a work intensity sufficient to produce claudication ) , strength training ( 3 hr/wk of resistive training of six muscle groups of each leg ) , or to a nonexercising control group .  Functional status was assessed by question naires characterizing walking ability ( Walking Impairment Question naire , WIQ ) , habitual physical activity level ( Physical Activity Recall , PAR ) , and physical , social , and role functioning , well-being , and overall health ( Medical Outcomes Study SF-20 , MOS ) . Patients alos had their activity levels monitored with an activity monitor ( Vitalog ) . RESULTS After 12 weeks of treadmill training  PAR scores increased by 48 metabolic equivalent hr/wk , the MOS physical functioning score by 24 percentage points , and the number of bouts of walking activity measured by the Vitalog by 4.5 bouts/hr ( all p < 0.05 ) . No changes were seen in WIQ scores . After 12 additional weeks of treadmill training improvements initially observed in the PAR , MOS , and Vitalog scores were maintained , and in addition the ability to walk distances ( WIQ ) improved by 31 percentage points , and the IC severity score had improved by 29 percentage points ( both p < 0.05 ) . After 12 weeks of strength training patients improved their WIQ walking speed , stair climbing scores , and MOS well-being scores with no other changes in functional status . Subjects in the control group did not improve functional status by any measure . Twelve weeks of treadmill training after the strength training program maintained WIQ walking speed scores , and activity level defined by Vitalog improved . Twelve weeks of combined treadmill and strength training after the control period had no effect on functional status . CONCLUSIONS A supervised treadmill training program improved functional status during daily activities , with 24 weeks more effective than 12 . In addition , treadmill training alone was more effective in improving functional status in patients with IC than strength training or combinations of the training modalities Previous studies have demonstrated that supervised strength training ( ST ) or walking training ( WT ) improve walking capacity in patients with claudication . However , it remains unknown whether these improvements would be sustained over a subsequent unsupervised period . This article reports the findings of a study to analyze whether the improvements in walking capacity , achieved with a supervised ST or WT , would be sustained over a subsequent unsupervised therapy period in patients with claudication . Patients were initially r and omized to supervised exercise consisting of ST  ( n = 15 ) or  WT  ( n = 15 ) for 12 weeks . After this period , 12 patients in each group consented to be followed for an additional 12 weeks of unsupervised therapy .  Initial claudication distance ( ICD ) and total walking distance ( TWD ) were measured at baseline , after the supervised period ( Week 12 ) and after the unsupervised period ( Week 24 ) . In comparison with baseline values , both groups similarly increased ICD and TWD at Week 12 . From Week 12 to Week 24 , both groups similarly decreased ICD ( ST : -55 ± 110 m and WT : -82 ± 142 m , P = .04 ) and TWD ( ST : -68 ± 186 m and WT : -128 ± 112 m , P < .01 ) . However , in both groups , ICD ( ST : + 126 ± 149 m and WT : + 50 ± 167 m , P = .01 ) and TWD ( ST : + 104 ± 162 m and WT : + 45 ± 139 m , P = .01 ) at Week 24 remained greater than baseline values . The conclusion is that supervised ST or WT followed by an unsupervised therapy period similarly decreased walking capacity in patients with claudication . However , after the unsupervised period , walking capacity remained at a higher level than before the onset of the supervised exercise-training period Introduction A typical symptom of chronic lower-limb ischaemia is lower-limb pain , which occurs during walking forcing the patient to stop , intermittent claudication ( IC ) .  Exercise rehabilitation is the basic form of treatment for these patients . Aim The aim of this study was to compare the effectiveness of three types of physical training programmes conducted over a 12-week period in patients with chronic lower-limb arterial insufficiency . Material s and Methods Ninety-five people qualified for the 3-month supervised motor rehabilitation programme , conducted three times a week . The respondents were assigned to three types of rehabilitation programmes using a pseudo-r and omization method : Group I ( TW ) , subjects undertaking treadmill walking training ; Group II ( NW ) , subjects undertaking Nordic walking training ; Group III ( RES+NW ) , subjects undertaking resistance and Nordic walking training . Treadmill test , 6 Minute Walk Test ( 6MWT ) , and  isokinetic test  were repeated after 3 months of rehabilitation , which 80 people completed . Results Combined training ( RES+NW ) is more effective than Nordic walking alone and supervised treadmill training alone for improving ankle force-velocity parameters ( p<0.05 ) in patients with intermittent claudication . Each of the proposed exercise rehabilitation programmes increased walking distance of patients with intermittent claudication ( p<0.05 ) , especially in 6MWT ( p=0.001 ) . Significant relationships of force-velocity parameters are observed in the maximum distance obtained in 6MWT , both in Group III ( RES + NW ) and in Group II ( NW ) at the level of moderate and strong correlation strength , which indicates that if the lower limbs are stronger the walking distance achieved in 6MWT is longer . Conclusions Given both the force-velocity parameters and the covered distance , the training RES + NW gives the most beneficial changes compared to training TW alone and NW alone . All types of training increased walking distance , which is an important aspect of the everyday functioning of people with IC OBJECTIVES The Exercise Therapy in Peripheral Arterial Disease ( EXITPAD ) study has shown supervised exercise therapy ( SET ) to be more effective regarding walking distance and quality of life than a ' go home and walk ' advice ( WA ) for patients with intermittent claudication . The present study aims to assess the cost-effectiveness of SET versus WA . PATIENTS AND METHODS Data from the EXITPAD study , a 12-month r and omised controlled trial in 304 patients with claudication , was used to study the proportion of costs to walking distance and quality of life . Two different incremental cost-effectiveness ratios ( ICERs ) were calculated for SET versus WA : costs per extra metre on the treadmill test , and costs per quality -adjusted life year ( QALY ) . QALYs were based on utilities derived from the EuroQoL-5 dimensions ( EQ-5D ) . RESULTS Mean total costs were higher for SET than for WA ( 3407 versus 2304 Euros ) , mainly caused by the costs of exercise therapy . The median walking distance was 620 m for SET and 400 m for  WA . QALYs were 0.71 for SET and 0.67 for WA . All differences were statistically significant . The ICER for cost per extra metre on the 12-month treadmill test was € 4.08 . For cost per QALY , the ICER was € 28,693 . CONCLUSION At a willingness-to-pay threshold of € 40,000 per QALY , SET likely is a cost-effective therapeutic option for patients with claudication BACKGROUND The optimal first-line treatment for intermittent claudication is currently unclear . OBJECTIVE To compare the cost-effectiveness of endovascular revascularization vs supervised hospital-based exercise in patients with intermittent claudication during a 12-month follow-up period . DESIGN R and omized controlled trial with patient recruitment between September 2002-September 2006 and a 12-month follow-up per patient . SETTING A large community hospital . PARTICIPANTS Patients with symptoms of intermittent claudication due to an iliac or femoro-popliteal arterial lesion ( 293 ) who fulfilled the inclusion criteria ( 151 ) were recruited . Excluded were , for example , patients with lesions unsuitable for revascularization ( iliac or femoropopliteal TASC-type D and some TASC type-B/C. INTERVENTION Participants were r and omly assigned to endovascular revascularization ( 76 patients ) or supervised hospital-based exercise ( 75 patients ) . MEASUREMENTS Mean improvement of health-related quality -of-life and functional capacity over a 12-month period , cumulative 12-month costs , and incremental costs per quality -adjusted life year ( QALY ) were assessed from the societal perspective . RESULTS In the endovascular revascularization group , 73 % ( 55 patients ) had iliac disease vs 27 % ( 20 patients ) femoral disease . Stents were used in 46/71 iliac lesions ( 34 patients ) and in 20/40 femoral lesions ( 16 patients ) . In the supervised hospital-based exercise group , 68 % ( 51 patients ) had iliac disease vs 32 % ( 24 patients ) with femoral disease . There was a non-significant difference in the adjusted 6- and 12-month EuroQol , rating scale , and SF36-physical functioning values between the treatment groups . The gain in total mean QALYs accumulated during 12 months , adjusted for baseline values , was not statistically different between the groups ( mean difference revascularization versus exercise 0.01 ; 99 % CI -0.05 , 0.07 ; P = .73 ) . The total mean cumulative costs per patient was significantly higher in the revascularization group ( mean difference euro2318 ; 99 % CI 2130 euros , 2506 euros ; P < .001 ) and the incremental cost per QALY was 231 800 euro/QALY adjusted for the baseline variables . One-way sensitivity analysis demonstrated improved effectiveness after revascularization ( mean difference 0.03 ; CI 0.02 , 0.05 ; P < .001 ) , making the incremental costs 75 208 euro/QALY . CONCLUSION In conclusion , there was no significant difference in effectiveness between endovascular revascularization compared to supervised hospital-based exercise during 12-months follow-up , any gains with endovascular revascularization found were non-significant , and endovascular revascularization costs more than the generally accepted threshold willingness-to-pay value , which favors exercise OBJECTIVE The initial treatment for intermittent claudication is supervised exercise therapy ( SET ) . Owing to limited capacity and patient transports costs of clinic-based SET , a concept of SET provided by local physiotherapists was developed . We hypothesized that provision of daily feedback with an accelerometer in addition to SET would further increase walking distance . METHODS This multicenter r and omized trial was set in vascular surgery outpatient clinics and included 304 patients with intermittent claudication . Patients were r and omized to exercise therapy in the form of " go home and walk " advice ( WA ) , SET , or SET with feedback . Local physiotherapists provided SET . The primary outcome measure was the change in absolute claudication distance . Secondary outcomes were the change in functional claudication distance and results on the Walking Impairment Question naire ( WIQ ) and Short-Form 36 ( SF-36 ) Health Survey after 12 months . RESULTS In 11 centers , 102 , 109 , and 93 patients were included , respectively , in the WA , SET , and SET with feedback groups , and data for 83 , 93 , and 76 , respectively , could be analyzed . The median ( interquartile range ) change in walking distance between 12 months and baseline in meters was 110 ( 0 - 300 ) in the WA group , 310 ( 145 - 995 ) in the SET group , and 360 ( 173 - 697 ) in the SET with feedback group ( P < .001 WA vs SET ) . WIQ scores and relevant domains of the SF-36 improved statistically significantly in the SET groups . CONCLUSIONS SET is more effective than WA in improving walking distance , WIQ scores , and quality of life for patients with intermittent claudication . Additional feedback with an accelerometer did not result in further improvement . SET programs should be made available for all patients with intermittent claudication Twenty-two patients with intermittent claudication were prospect ively enrolled in a 12-week program of supervised , grade d treadmill exercise therapy . Severity and distribution of arterial occlusive disease were ascertained by noninvasive determination of segmental lower extremity blood pressures and waveforms . No attempt was made to modify risk factors for atherosclerotic occlusive disease . The exercise-induced reduction of the ankle pressure and its recovery were recorded over time , and the area under this curve , the " ischemic window , " represents the severity of the ischemic deficit . Absolute systolic ankle pressure , ankle-brachial index , maximum walking time , claudication pain time , and the ischemic window were measured before and after exercise training in all subjects . Maximum walking time and claudication pain time increased 659 % and 846 % , respectively , among the 19 patients completing the 12-week program ( p = 0.001 ; p = 0.0002 ) . These patients underwent a mean reduction of 58.7 % in the ischemic window after a st and ardized workload ( p less than 0.05 ) , and this correlated with the degree of symptomatic improvement . Absolute ankle pressure and ankle-brachial index were unchanged after exercise training . This study confirms the utility of supervised exercise therapy in the treatment of intermittent claudication . The ischemic window is a useful method for quantifying the ischemic deficit produced by exercise and provides a reproducible means of documenting functional improvement in patients undergoing exercise training Background — Claudication is a common and disabling symptom of peripheral artery disease that can be treated with medication , supervised exercise ( SE ) , or stent revascularization ( ST ) . Methods and Results — We r and omly assigned 111 patients with aortoiliac peripheral artery disease to receive 1 of 3 treatments : optimal medical care ( OMC ) , OMC plus SE , or OMC plus ST . The primary end point was the change in peak walking time on a grade d treadmill test at 6 months compared with baseline . Secondary end points included free-living step activity , quality of life with the Walking Impairment Question naire , Peripheral Artery Question naire , Medical Outcomes Study 12-Item Short Form , and cardiovascular risk factors . At the 6-month follow-up , change in peak walking time ( the primary end point ) was greatest for SE , intermediate for ST , and least with OMC ( mean change versus baseline , 5.8±4.6 , 3.7±4.9 , and 1.2±2.6 minutes , respectively ; P<0.001 for the comparison of SE versus OMC , P=0.02 for ST versus OMC , and P=0.04 for SE versus ST ) . Although disease-specific quality of life as assessed by the Walking Impairment Question naire and Peripheral Artery Question naire also improved with both SE and ST compared with OMC , for most scales , the extent of improvement was greater with ST than SE . Free-living step activity increased more with ST than with either SE or OMC alone ( 114±274 versus 73±139 versus −6±109 steps per hour ) , but these differences were not statistically significant . Conclusions — SE results in superior treadmill walking performance than ST , even for those with aortoiliac peripheral artery disease . The contrast between better walking performance for SE and better patient-reported quality of life for ST warrants further study . Clinical Trial Registration — URL : http:// clinical trials.gov/ct/show/NCT00132743?order=1 . Unique identifier : NCT00132743
In claudication patients , SE is more effective than UE at improving maximal walking and claudication distances , yet there is no difference in general quality of life or patient-reported community-based walking .
BACKGROUND Supervised exercise ( SE ) is widely accepted as an effective therapy for intermittent claudication ( IC ) , but its use is limited by cost .
Unsupervised exercise ( UE ) represents a less costly alternative .
We assessed the comparative effectiveness of SE vs UE in patients with IC .