Creatine supplements in patients with idiopathic inflammatory myopathies who are clinically weak after conventional pharmacologic treatment: Six-month, double-blind, randomized, placebo-controlled trial. Resistive Home Exercise in Patients with Recent-onset Polymyositis and Dermatomyositis — A Randomized Controlled Single-blinded Study with a 2-year Followup Improved exercise performance and increased aerobic capacity after endurance training of patients with stable polymyositis and dermatomyositis Tablet-Based Strength-Balance Training to Motivate and Improve Adherence to Exercise in Independently Living Older People: A Phase II Preclinical Exploratory Trial The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials Improvement in Aerobic Capacity After an Exercise Program in Sporadic Inclusion Body Myositis Intensive aerobic and muscle endurance exercise in patients with systemic sclerosis: a pilot study Benefit of 6 months long-term physical training in polymyositis/dermatomyositis patients. The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. The safety of a resistive home exercise program in patients with recent onset active polymyositis or dermatomyositis. Improvement of physical fitness and muscle strength in polymyositis/dermatomyositis patients by a training programme. Benefits of intensive resistance training in patients with chronic polymyositis or dermatomyositis. The effect of physical exercise following acute disease exacerbation in patients with dermato/polymyositis Improvement in Health and Possible Reduction in Disease Activity Using Endurance Exercise in Patients With Established Polymyositis and Dermatomyositis: A Multicenter Randomized Controlled Trial With a 1‐Year Open Extension Followup CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
OBJECTIVE To test the hypothesis that oral creatine supplements with exercise are more effective than exercise alone in improving muscle function in patients with established dermatomyositis or polymyositis receiving chronic medical therapies who are clinical ly weak yet stable . METHODS In a 6-month , 2-center , double-blind , r and omized controlled trial , patients were r and omized to receive oral creatine supplements  ( 8 days , 20 gm/day then 3 gm/day ) or placebo . All patients followed a home exercise program . The primary outcome was aggregate functional performance time ( AFPT ) , reflecting the ability to undertake high-intensity exercise . Secondary outcomes included a functional index measuring endurance and muscle bioenergetics on (31)P magnetic resonance spectroscopy ( (31)P MRS ) .  Patients were receiving stable immunosuppressive treatment and /or corticosteroids . RESULTS A total of 37 patients with polymyositis or dermatomyositis were r and omized ( 19 to creatine , 18 to placebo ) ; 29 completed 6 months . Intent-to-treat analyses demonstrated that AFPT improved significantly at 6 months with creatine ( median decrease 13 % , range -32 - 8 % ) compared with placebo ( median decrease 3 % , range -13 - 16 % ; P = 0.029 by Mann-Whitney U test ) . A completer analysis also showed significant benefits from creatine ( P = 0.014 ) . The functional index improved significantly with both creatine and placebo ( P < 0.05 by paired Wilcoxon 's rank sum test ) , with a significant benefit between groups in the completer analysis only . Phosphocreatine/beta-nucleoside triphosphate ratios using MRS increased significantly in the creatine group ( P < 0.05 ) but not in the control group . No clinical ly relevant adverse events were associated with creatine . CONCLUSION Oral creatine supplements combined with home exercises improve functional performance without significant adverse effects in patients with polymyositis or dermatomyositis . They appear safe , effective , and inexpensive Objective . To evaluate the outcome of resistive home exercise and its possible longterm influence on health , disability , and disease activity in patients with active polymyositis ( PM ) or dermatomyositis ( DM ) . Methods . Nineteen patients with recent-onset PM/DM were included after introduction of high-dose prednisolone .  They were assessed by independent assessors as to perceived health , muscle performance , aerobic capacity , and serum creatine phosphokinase ( CPK ) at baseline and after 24 weeks , including repeated muscle biopsies at 24 weeks ( single-blinded r and omized controlled study ) , and in an open-label followup at 52 , 78 , and 104 weeks . Patients were r and omized to 12 weeks , 5 days/week resistive home exercise with telephone support and encouragement for another 12 weeks of twice-a-week home or gym exercise ( EG , n = 10 ) or to 24 weeks , 5 days/week range of motion exercise ( CG , n = 9 ) . Patients in the CG group without inflammatory infiltrates in muscle biopsies at 24 weeks were invited to the 12-week resistive home exercises . Results . At baseline , the EG had poorer perceived health , but otherwise the groups were comparable . At 24 weeks , both groups improved in muscle performance and aerobic capacity ( p < 0.001 to < 0.05 ) with no signs of increased inflammation assessed by CPK levels or muscle biopsies . Both groups improved in muscle performance and aerobic capacity up to 52 weeks ( p < 0.05 ) lasting to 104 weeks in the EG ( p < 0.05 ) and presented minor improvements in perceived health . Conclusion . Our study supports the safety of resistive exercise in patients with active PM/DM but did not reveal any between-group differences in exercise effects . An individually adapted physical therapist – supervised home exercise program might be recommended in early active PM/DM , with regular evaluation of muscle performance and health Introduction This r and omized , controlled study on patients with polymyositis or dermatomyositis was based on three hypotheses : patients display impaired endurance due to reduced aerobic capacity and muscle weakness , endurance training improves their exercise performance by increasing the aerobic capacity , and endurance training has general beneficial effects on their health status . Methods In the first part of this study , we compared 23 patients with polymyositis or dermatomyositis with 12 age- and gender-matched healthy controls . A subgroup of patients were r and omized to perform a 12-week endurance training program ( exercise group , n = 9 ) or to a non-exercising control group ( n = 6 ) . We measured  maximal oxygen uptake ( VO2 max ) and the associated power output  during a progressive cycling test . Endurance was assessed as the cycling time to exhaustion at 65 % of VO2 max . Lactate levels in the vastus lateralis muscle were measured with microdialysis . Mitochondrial function was assessed by measuring citrate synthase ( CS ) and β-hydroxyacyl-CoA dehydrogenase ( β-HAD ) activities in muscle biopsies . Clinical improvement was assessed according to the International Myositis Assessment and Clinical Studies Group ( IMACS ) improvement criteria . All assessors were blinded to the type of intervention ( that is , training or control ) . Results Exercise performance and aerobic capacity were lower in patients than in healthy controls , whereas lactate levels at exhaustion were similar . Patients in the exercise group increased their cycling time , aerobic capacity and CS and β-HAD activities , whereas lactate levels at exhaustion decreased . Six of nine patients in the exercise group met the IMACS improvement criteria . Patients in the control group did not show any consistent changes during the 12-week study . Conclusions Polymyositis and dermatomyositis patients have impaired endurance , which could be improved by 12 weeks of endurance training . The clinical improvement corresponds to increases in aerobic capacity and muscle mitochondrial enzyme activities . The results emphasize the importance of endurance exercise in addition to immunosuppressive treatment of patients with polymyositis or dermatomyositis . Trial registration Clinical Trials.gov : Background Reaction time , coordination , and cognition performance typically diminish in older adults , which may lead to gait impairments , falls , and injuries . Regular strength – balance exercises are highly recommended to reduce this problem and to improve health , well-being , and independence in old age . However , many older people face a lack of motivation in addition to other strong barriers to exercise . We developed ActiveLifestyle , an information technology (IT)-based system for active and healthy aging aim ing at improving balance and strength . ActiveLifestyle is a training app that runs on a tablet and assists , monitors , and motivates older people to follow personalized training plans autonomously at home . Objective The objectives were to ( 1 ) investigate which IT-mediated motivation strategies increase adherence to physical exercise training plans in older people , ( 2 ) assess the impact of ActiveLifestyle on physical activity behavior change , and ( 3 ) demonstrate the effectiveness of the ActiveLifestyle training to improve gait speed . Methods A total of 44 older adults followed personalized , 12-week strength and balance training plans . All participants performed the exercises autonomously at home . Question naires were used to assess the technological familiarity and stage of behavior change , as well as the effectiveness of the motivation instruments adopted by ActiveLifestyle . Adherence to the exercise plan was evaluated using performance data collected by the app and through information given by the participants during the study . Pretests and posttests were performed to evaluate gait speed of the participants before and after the study . Results Participants were 75 years ( SD 6 ) , predominantly female ( 64 % ) , held a trade or professional diploma ( 54 % ) , and their past profession was in a sitting position ( 43 % ) . Of the 44 participants who enrolled , 33 ( 75 % ) completed the study . The app proved to assist and motivate independently living and healthy older adults to autonomously perform strength – balance exercises ( median 6 on a 7-point Likert scale ) . Social motivation strategies proved more effective than individual strategies to stimulate the participants to comply with the training plan , as well as to change their behavior permanently toward a more physically active lifestyle . The exercises were effective to improve preferred and fast gait speed . Conclusions ActiveLifestyle assisted and motivated independently living and healthy older people to autonomously perform strength – balance exercises over 12 weeks and had low dropout rates . The social motivation strategies were more effective to stimulate the participants to comply with the training plan and remain on the intervention . The adoption of assistive technology devices for physical intervention tends to motivate and retain older people exercising for longer periods of time Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Objectives : The study aim ed to investigate the effects of a combined functional and aerobic exercise program on aerobic capacity , muscle strength , and functional mobility in a group of patients with sporadic inclusion body myositis ( IBM ) . Methods : Aerobic capacity , muscle strength , and functional capacity assessment s were conducted on 7 participants with sporadic IBM before and after a 12-week exercise program , which included resistance exercises and aerobic stationary cycling 3 times per week on alternative days . Results : Aerobic capacity of the group increased significantly by 38 % , and significant strength improvements were observed in 4 of the muscle groups tested ( P < 0.05 ) . The exercise program was well tolerated , and there was no significant change in the serum creatine kinase level after the exercise period . Conclusions : An aerobic exercise program can be safely tolerated by patients with sporadic IBM and can improve aerobic capacity and muscle strength when combined with resistance training . These findings indicate that aerobic and functional muscle strengthening exercise should be considered in the management of patients with IBM Background No previous studies have examined the effect of intensive exercise in systemic sclerosis patients with pulmonary impairment . The objective of this study was to examine the effect of an eight-week intensive aerobic exercise and muscle endurance training program for patients with systemic sclerosis with 50–100 % of forced vital capacity . Methods A single-subject experimental design with repeated systematic measures during a six week A-phase ( non-interventional baseline period ) and an eight week B-phase ( exercise intervention period ) was used . Three women and one man with median age 66 years and median disease duration of 3.5 years completed aerobic exercise corresponding to 15 on the Borg RPE scale ( strenuous ) and muscular endurance training three times/week . Physical capacity ( six-minute walk test ) , aerobic capacity ( submaximal treadmill test ) and muscle endurance in shoulder and hip flexion ( Functional Index 2 ) were assessed every other week throughout the 14-week study . Activity limitation ( Health Assessment Question naire ) , quality of life ( Short Form 36 ) , Raynaud , Fatigue and Global Health during the recent week ( Visual Analogue Scales ) were assessed at weeks 0 , 6 , 14 . Results Three participants improved significantly in muscular endurance , and two participants improved significantly or clinical ly relevant in aerobic capacity . All other variables remained unchanged , except for a trend towards reduced fatigue . Conclusions This eight week exercise program was largely successful with positive effects on aerobic capacity and muscle endurance . Trial registration Clinical trials.gov Identifier : OBJECTIVE The benefit of long-term physical training in patients with chronic polymyositis or dermatomyositis ( PM/DM ) was studied prospect ively . METHODS Eight patients with chronic PM/DM participated in a training programme for 6 months . A group of five PM/DM patients without any physical training  was observed for control purpose s. RESULTS While there was no significant change in serum creatine phosphokinase ( CPK ) levels , the ' activities of daily living ( ADL ) ' score improved significantly ( P < 0.03 ) , peak isometric torque ( PIT ) generated by muscle groups in the lower extremities rose significantly ( P < 0.03 ) and there was a statistically highly significant increase in peak oxygen uptake ( VO2max ) relative to body weight ( P < 0.02 ) due to the long-term training . The patients improved their aerobic capacity by 28 % , which is clinical ly significant . In the untrained patients , no improvement in these target parameters was observed . CONCLUSION In clinical ly stable DM/PM patients , long-term physical training can safely be performed and is recommended as part of a comprehensive rehabilitation management , particularly in view of the cardiopulmonary risk in these patients OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity The objective was to investigate whether a 12-week resistive home exercise program in addition to conventional medical treatment could be safely performed regarding muscle inflammation , muscle function , and quality of life in patients with active polymyositis ( PM ) or dermatomyositis ( DM ) . Eleven patients diagnosed with active PM or DM were included .  Muscle biopsies and Magnetic Resonance Imaging ( MRI ) of the thighs were performed . Quality of life , function , and subjective global disease impact ( SGDI ) were assessed and creatine phosphokinase levels ( CPK ) were analysed . The patients exercised with the exercise program for 15 minutes and took a 15-minute walk five days a week for 12 weeks . After the exercise period there was no sign of increased muscle inflammation . The group showed significantly improved function and quality of life compared to the start of study . It seems that this exercise program safely can be employed in patients with active PM or DM , and we suggest that physical exercise should be included in the rehabilitation of these patients In the present investigation , the benefit of physical training in patients with inflammatory myopathy was studied . In this prospect i ve , r and omized , controlled study , 14 patients with polymyositis ( PM ) or dermatomyositis ( DM ) were investigated . The training , consisting of bicycle exercise and step aerobics , took place over a 6 week period . Baseline and endpoint measurements included an ' activities of daily living ' ( ADL ) score , peak isometric torque ( PIT ) generated by muscle groups in the lower extremities , peak oxygen consumption ( VO2max ) , and creatine phosphokinase ( CPK ) levels . There was no significant rise in disease activity in the training group in comparison to the controls . The ADL score for the treatment group , in comparison to the control group , improved ( P < 0.02 ) , PIT rose ( P < 0.05 ) and there was a statistically significant increase in oxygen uptake relative to body weight ( P < 0.05 ) . No rise in inflammatory activity , but significant improvement in muscle strength , oxygen uptake and well-being , were found in patients with inflammatory myopathy as a result of physical training . Besides medication , a physical training programme consisting mainly of concentric muscle contractions should therefore be an integral part of therapy , particularly in view of the cardiopulmonary risk of these patients OBJECTIVE To investigate the benefits and safety of an intensive muscular training program in patients with chronic polymyositis ( PM ) and dermatomyositis ( DM ) . METHODS Nine patients with chronic PM or DM ( median age 53 years , range 44 - 61 ) were included . Assessment s of impairment ( 10 - 15 voluntary repetition maximum [ VRM ] , the Functional Index 2 [ FI-2 ] , the Grippit , and pain rated on the Borg CR-10 scale ) , activity limitation ( Myositis Activities Profile ) , and participation restriction ( patients ' disease impact on well-being ) were performed 4 weeks prior to baseline , at baseline , and after 7 weeks of exercise . A 6-item core set of disease activity measures was administered and muscle biopsy sample s of vastus lateralis were obtained at baseline and after 7 weeks of exercise . Response criteria at an individual level were set for disability and disease activity . The patients exercised 3 days per week for 7 weeks on loads allowing 10 VRM . RESULTS On a group level there were no significant differences between assessment s at 4 weeks before baseline compared with baseline . The group improved significantly regarding 10 - 15 VRM and FI-2 at 7 weeks compared with baseline ( P < 0.05 ) . All patients were responders with respect to impairment and 2 were activity limitation responders whereas participation restriction remained unchanged in all . Two patients were responders with reduced disease activity and no patient had signs of increased muscle inflammation in the muscle biopsy sample after 7 weeks of exercise .  CONCLUSION Patients with chronic , stable PM and DM can perform this intensive resistive exercise program with beneficial effects on impairment and activity limitation without increased muscle inflammation Objective : To study the effect of physical exercise shortly after an acute episode of dermato/polymyositis ( DM/PM ) . Design : Pilot study of a descriptive nature . Setting : Rehabilitation unit of a large general hospital . Subjects : Ten patients 2–3 weeks after an acute phase of DM/PM ( early recovery group ) and 11 patients in the inactive stage of DM/PM for at least three months ( chronic stage group ) . Interventions : Isotonic muscle training consisted of several series of different repeated movements at 65–70 % of individual maximal repetition limit . Special training was applied for the respiratory muscles . Relaxing baths , mud packs and massages were also applied . Outcome measures : Dynamometer and spirometer were used for measuring the changes in muscle strength and respiratory function . Disability tests were done before and after therapy . Results : No disease relapses or decreases in muscle function were seen . In the early recovery group , the average muscle strength improvement was 17 ± 31 % ( p > 0.05 ) in the proximal muscles and 37 ± 23 % ( p < 0.05 ) in the distal muscles , while the vital capacity also increased by 17 ± 21 % ( p < 0.05 ) . In the chronic stage group the average improvement in muscle strength was 46 ± 34 % ( p < 0.05 ) in the proximal muscles and 37 ± 29 % ( p < 0.05 ) in the distal muscles . By the end of the therapy both groups showed improvements in disability tests ( p < 0.05 ) . Conclusions : Physical training started 2–3 weeks following an acute exacerbation of the disease seems to be useful and safe . Some improvement in muscle strength and respiratory function can be obtained , muscle atrophy due to inactivity may be partially prevented and the level of disability can be decreased To determine the effects of a 12‐week endurance exercise program on health , disability , VO2 max , and disease activity in a multicenter r and omized controlled trial in patients with established polymyositis ( PM ) and dermatomyositis ( DM ) , and to evaluate health and disability in a 1‐year open extension study The CONSORT statement is used worldwide to improve the reporting of r and omised controlled trials . Kenneth Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . To encourage dissemination of the CONSORT 2010 Statement , this article is freely accessible on bmj.com and will also be published in the Lancet , Obstetrics and Gynecology , PLoS Medicine , Annals of Internal Medicine , Open Medicine , Journal of Clinical Epidemiology , BMC Medicine , and Trials
Abstract Physical exercise seems to be a safe and effective intervention in patients with inflammatory myopathy ( IM ) .
However , the optimal training intervention is not clear .
To achieve an optimum training effect , physical exercise training principles must be considered and to replicate research findings , FITT components ( frequency , intensity , time , and type ) of exercise training should be reported .