2.1. Study Design
knee osteoarthrosis, musculoskeletal disorders, cardiovascular and/or metabolic diseases, neurological diseases, cardiovascular and/or metabolic disease
CARDIAC EVENT, NEUROLOGICAL DISEASE, LUNG DISEASE, HBP, KNEE OSTEOARTHROSIS, LUNG DISEASES, RECRUITMENT, PULMONARY DISEASES, MUSCULOSKELETAL DISORDERS, HIGH BLOOD PRESSURE, HYPERTENSIVE CRISIS
Our study was a non-randomized controlled study conducted from June 2014 to June 2016 in a rehabilitation clinic for the elderly, located in the state of São Paulo, Brazil, where participants already practiced regular physical activity (practice light or moderate intensity physical activities for about 20 min a day). We adopted the Risk of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool to reduce the likelihood of bias.Participants were recruited from an elderly rehabilitation clinic. All 100 elderly patients in the clinic were invited to participate. In total, five patients refused to participate in our research. A total of 95 elderly people were included, but five were excluded. Of those who were excluded from the HBP group, two had lung disease, while three were excluded from the control group because they had knee osteoarthrosis that made it impossible for them to walk properly on a treadmill. Although 90 participants were allocated in 2 groups (45 in each group), only 42 individuals in each group completed the study. In the HBP group, three participants reported health problems on the day of the testing procedure and three in the control group did not attend the clinic after recruitment (Elderly people were invited to be part of the intervention and control groups. All elderly people were assessed as active according to their level of physical activity, measured by the short version of the International Physical Activity Questionnaire (IPAQ).We split all participants non-randomly into two groups: a group without cardiovascular and/or metabolic diseases called the “Control Group” (CG), and another group diagnosed with high blood pressure (the HBP Group). Outcomes were measured before, during, and after 30 min of aerobic exercise on a treadmill.Inclusion criteria for the HBP group included: (1) diagnosis of cardiovascular and/or metabolic disease, (2) HBP controlled with medical clearance for physical activity, (3) practice of regular physical activity, (4) age over 65 years old, and (5) signing of the informed consent form. For the control group, the inclusion criteria included: (1) no diagnosis of cardiovascular and/or metabolic diseases, (2) practice of regular physical activity, and (3) age over 65 years old. Exclusion criteria for the CG included: (1) lung diseases, (2) concomitant neurological diseases, (3) the presence of musculoskeletal disorders that did not allow the use of a treadmill, and (4) the use of any medication that could alter autonomic modulation. Exclusion criteria for the HBP group included: (1) pulmonary diseases, (2) concomitant neurological diseases, (3) the presence of musculoskeletal disorders that did not allow the use of a treadmill, and (4) any recent cardiac event or a hypertensive crisis. They took diuretics and renin-angin-aldosterone system inhibitors, while some individuals used a combination of the two drugs. None of the study subjects took antidepressants.Our study followed the Brazilian regulations on human subject protection contained in Resolutions 466/12 and 251/97 of the National Health Council. It was approved by the Institutional Review Board of the ABC Medical School (CAEE protocol 02830612.1.0000.0082/#108.260). Brazilian Registry of Clinical Trials (REBEC): #RBR-5mgrttm.Flow chart of the study design.