Effects of a Structured Home-Based Exercise and Education Program on Clinical and Functional Outcomes in Individuals With Chronic Venous Insufficiency: A Randomized Controlled Trial
Effects of a Structured Home-Based Exercise and Education Program on Clinical and Functional Outcomes in Individuals With Chronic Venous Insufficiency: A Randomized Controlled Trial
The goal of this clinical trial is to learn whether a structured home-based exercise and education program can improve quality of life and leg symptoms in adults with chronic venous insufficiency. Chronic venous insufficiency occurs when the veins in the legs do not return blood effectively toward the heart. The main questions the study aims to answer are:
Does the exercise and education program improve quality of life related to chronic venous insufficiency after 8 weeks, and is any improvement maintained at Week 12? Does the program reduce leg symptoms after 8 weeks, and is any improvement maintained at Week 12?
Researchers will compare participants who receive the structured exercise and education program in addition to standard medical care with participants who receive standard medical care and routine lifestyle advice without structured exercise training.
A total of 120 participants will be assigned by chance to one of the two groups. Participants will:
Continue the standard medical care recommended by their physicians Attend assessments at the beginning of the study, at Week 8, and at Week 12 Complete questionnaires and tests assessing quality of life, leg symptoms, walking capacity, calf muscle endurance, physical activity, pain, heaviness, and lower-limb swelling
Participants assigned to the intervention group will also attend a 30- to 45-minute group education session, perform home-based exercises for 20 to 30 minutes per day on at least 5 days per week for 8 weeks, record their exercise sessions, and receive weekly follow-up by telephone or message.
Inclusion Criteria:
Exclusion Criteria:
alpozel@ibu.edu.tr+903742534520 ext. 6155
The sample size was calculated using R version 4.5.3 with the pwr package. Previously published VEINES-QOL change data suggested a standardized effect size of approximately 0.72. However, because this estimate was derived from a single small study with very low-certainty evidence, a more conservative effect size of Cohen's d = 0.55 was prespecified. For a two-sided independent-samples comparison with a significance level of 0.05 and 80% statistical power, 53 participants were required in each group (106 participants in total). The target enrollment was increased to 120 participants to allow for potential attrition.
The allocation sequence will be generated before participant enrollment by a staff nurse designated to manage the allocation process, using a prespecified script based on the blockrand package in R version 4.5.3, with a 1:1 allocation ratio and randomly varying block sizes. The designated staff nurse will otherwise not be involved in eligibility assessment, participant enrollment, intervention delivery, or outcome assessment. The sequence will be maintained in a password-protected electronic allocation system accessible only to the designated staff nurse. After eligibility has been confirmed, written informed consent has been obtained, and baseline assessments have been completed, the enrolling researcher will submit the participant's unique study identification number for allocation. The system will release only the assignment for the current participant, while future assignments will remain concealed.
Repeated-measures data will be analyzed using linear mixed-effects models. Group, time, and the group-by-time interaction will be included as fixed effects, with participant-specific random effects included as appropriate. Statistical tests will be two-sided, with the significance level set at 0.05.
alpozel@ibu.edu.tr+903742534520 ext. 6155