Background Chronic venous insufficiency (CVI) causes pathophysiological changes in the lower-limb muscles, particularly the calf muscles, and limits ankle range of motion (ROM). These changes reduce functional activities and decrease quality of life (QOL). Although several studies have shown the benefits of exercise (strengthening the calf muscles to improve calf-muscle pumping and QOL) in patients with CVI, few studies are randomized controlled trials. This has led to a weak indication of exercise for the treatment of patients with CVI. The aim of this study is to analyze the effects of a supervised exercise program to improve calf-muscle endurance as well as QOL in patients with CVI. Methods/design This is an evaluator-blind, randomized clinical trial with an 8-week duration and a follow-up evaluation at week 16. A pilot study with subjects with a CVI diagnosis will be performed to calculate sample size. The participants will be randomly allocated (1:1) into a treatment or a control group (usual care/no intervention). The treatment intervention consists of a bi-weekly supervised exercise program of the lower limbs that will include aerobic training, strengthening and cardiovascular exercises. The participants from both groups will participate in a health education lecture. Primary outcomes are changes in calf-muscle endurance and QOL score. Secondary outcomes are changes in exercise capacity, ankle ROM, electrical muscle activity and cardiac output. The first statistical comparison will be performed after 8 weeks’ intervention. Discussion Patients with CVI may have an impaired calf-muscle pump and decreased exercise capacity. A randomized controlled trial evaluating a supervised exercise program should provide much needed information on the management of CVI to promote health and independence. Trial registration This study was registered on the Brazilian Clinical Trials Database (REBEC) (RBR-57xtk7). The results will be disseminated at scientific events, presentations, and publications in peer-reviewed journals.

Background : Chronic venous insufficiency (CVI) causes pathophysiological changes in lower limb muscles, particularly calf muscles, and limits ankle range of motion (ROM). These changes reduce functional activities and decreases the quality of life (QOL). Although several studies have shown benefits of exercise (strengthening the calf muscles to improve calf muscle pumping and QOL in patients with CVI), only a few randomized clinical trials are based on exercise programs. This has led to a weak indication of exercise for the treatment of patients with CVI. The aim of this study is to analyze the effects of a supervised exercise program to improve calf muscle strength and endurance besides QOL in patients with CVI. Methods : This is an evaluator-blind, randomized clinical trial with an 8-week duration and 16-week follow-up period. This study is planned to include 26 participants with CVI diagnosis. The participants will be randomly allocated (1:1) into a treatment or control group (usual care/no intervention). The treatment intervention consists of a bi-weekly supervised exercise program of the lower limbs that will include aerobic training, strengthening, and cardiovascular exercises. The participants from both groups will participate in a health education lecture. Primary outcomes are change of calf muscle endurance, strength, and QOL score and secondary outcomes are change of exercise capacity and ankle ROM. Discussion : Patients with CVI may have an impaired calf muscle pump. Strengthening calf muscles and increasing resistance can significantly improve exercise capacity and health in patients with CVI. A supervised exercise program will provide much needed information on the management of CVI to promote health and independence. Trial registration: This study was registered on the Brazilian Clinical Trials Database (REBEC) (RBR-57xtk7). The results will be disseminated at scientific events, presentations, and publications in peer reviewed journals.

Background: Triceps surae muscle changes and range of motion decrease resulting from pathophysiological changes seen in subjects with CVI leading to important impairment of functional activities related to lower limbs in these individuals. Several studies have shown the benefits of exercise therapy focusing on triceps surae muscle strengthening to improve calf muscle pumping. Randomized studies using exercise programmes for lower limbs in subjects with CVI are still rare in the literature, leading to a weak indication of this modality to treat this population. The aim of this study is to investigate the effects of a supervised exercise programme to improve functional capacity and the quality of life in individuals with CVI. Methods: This is an evaluator-blinded randomized clinical trial. Individuals will be randomly allocated in two groups: 1) treatment group (TG), in which they will be submitted to a supervised exercise programme for lower limbs; 2) control group (CG), in which the same treatment will be maintained but without the performance of any supervised exercise modality. Participants from both groups will participate in a health education speech. The study will compare the evaluation and reevaluation results between subjects submitted to the exercise programme and the control group by the following outcomes: range of motion, calf muscle endurance by the heel rise test, physical capacity by the step test (ST6), and quality of life by the VEINES-QOL. Discussion: Calf muscle function can be improved in people with venous disease with significant improvements in functional capacity, supervised exercise programme will provide much needed information on management of this chronic disease to promote health and independence in this population. Trial registration: The study was registered on the Brazilian Clinical Trials Database (REBEC) (RBR57xtk7). The results will be disseminated by scientific events presentations and publication in peer reviewed journals. Keywords: Exercise, Resistance Training, Exercise Therapy, Venous Insufficiency, Randomized Controlled Trial, Rehabilitation.

Background: Chronic venous insufficiency (CVI) causes pathophysiological changes in lower limb muscles, particularly calf muscles, and limits ankle range of motion (ROM). These changes reduce functional activities and decreases quality of life (QOL). Although several studies have shown benefits of exercise (strengthening the calf muscles to improve calf muscle pumping and QOL) in patients with CVI, few studies are randomized controlled trials. This has led to a weak indication of exercise for the treatment of patients with CVI. The aim of this study is to analyze the effects of a supervised exercise program to improve calf muscle endurance as well as QOL in patients with CVI. Methods: This is an evaluator-blind, randomized clinical trial with an 8-week duration and a follow-up evaluation at week 16. A pilot study with subjects with CVI diagnosis will be performed to calculate sample size. The participants will be randomly allocated (1:1) into a treatment or control group (usual care/no intervention). The treatment intervention consists of a bi-weekly supervised exercise program of the lower limbs that will include aerobic training, strengthening, and cardiovascular exercises. The participants from both groups will participate in a health education lecture. Primary outcomes are changes in calf muscle endurance and QOL score. Secondary outcomes are changes in exercise capacity, ankle ROM, electrical muscle activity and cardiac output. Discussion: Patients with CVI may have an impaired calf muscle pump and decreased exercise capacity. A randomized controlled trial evaluating a supervised exercise program will provide much needed information on the management of CVI to promote health and independence. Trial registration: This study was registered on the Brazilian Clinical Trials Database (REBEC) (RBR-57xtk7). The results will be disseminated at scientific events, presentations, and publications in peer reviewed journals. Keywords: Exercise, Resistance Training, Exercise Therapy, Venous Insufficiency, Randomized Controlled Trial, Rehabilitation