Structured Home-Based Exercise and Education for Chronic Venous Insufficiency

Abant Izzet Baysal University120 enrolled

Overview

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.

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.

Interventions

Structured Home-Based Exercise and Education ProgramBEHAVIORAL

The intervention will be provided in addition to standard medical care. Participants will attend a 30- to 45-minute face-to-face group education and practical training session led by a physiotherapist. Education will cover chronic venous insufficiency, leg elevation, physical activity, weight management, lifestyle recommendations, and compression stocking use when prescribed. Participants will receive practical training in ankle pumping, plantar flexion and dorsiflexion, heel raises, calf muscle activation, walking, and light stretching. Correct exercise performance will be checked individually. Participants will perform the program at home for 20 to 30 minutes per day, at least 5 days per week, for 8 weeks. Adherence and potential adverse symptoms will be monitored weekly by telephone call or text message.

Standard Care (in control arm)OTHER

Standard care consists of physician-prescribed medical treatment and routine lifestyle recommendations for chronic venous insufficiency. Participants in the experimental arm will receive the structured home-based exercise and education program in addition to standard care.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 18 years or older * Physician-confirmed diagnosis of chronic venous insufficiency * CEAP clinical class C1-C4 * Ability to walk independently * Ability to understand written and verbal instructions and participate in the group education and home-based exercise program * Provision of written informed consent * Symptomatic chronic venous disease affecting at least one lower limb * Clinically stable and medically suitable for light-to-moderate exercise Exclusion Criteria: * Active or healed venous ulcer (CEAP clinical class C5 or C6) * Acute deep vein thrombosis or active thromboembolic disease * Lower-extremity surgery within the previous 3 months * Severe peripheral arterial disease * Uncontrolled cardiac, pulmonary, metabolic, or systemic disease * Neurological, orthopedic, or vestibular disorder that prevents performance of the prescribed exercises or walking tests * Pregnancy * Participation in another regular exercise or rehabilitation program during the study * Severe cognitive, psychiatric, or communication disorder that could prevent adherence to the study protocol * Active lower-extremity infection, cellulitis, or acute superficial vein thrombosis * Coexisting lymphedema or lower-extremity edema primarily attributable to a non-venous cause * Planned venous surgery, endovenous ablation, sclerotherapy, or another venous intervention during the 12-week study period

Outcomes

Primary Outcomes

Change in VEINES-QOL Score

VEINES-QOL is the 25-item quality-of-life summary score derived from the 26-item VEINES-QOL/Sym questionnaire. It assesses the impact of chronic venous disease on symptoms, daily activities, and psychological well-being during the previous 4 weeks. Scores will be transformed to a 0-100 scale, with higher scores indicating better disease-specific quality of life. Change from baseline will be calculated at Weeks 8 and 12; positive change values indicate improvement.