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Structured Home-Based Exercise and Education for Chronic Venous Insufficiency

Sponsor: Abant Izzet Baysal University • ClinicalTrials.gov ID: NCT07777978

Registry updated: 2026-08-31

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Description

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.

Interventions

Structured Home-Based Exercise and Education Program (Behavioral)
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 criteria

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

Conditions

Chronic Venous Insufficiency, CVI

Locations

Bolu Abant Izzet Baysal University — Bolu, Bolu, Turkey (Türkiye)

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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