Structured Home-Based Exercise and Education for Chronic Venous Insufficiency (NCT07777978)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (12 items).
Location: Bolu Abant Izzet Baysal University — Bolu, Bolu
Age range: 18 Years
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Bolu Abant Izzet Baysal University — Bolu, Bolu
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.