Structured Home-Based Exercise and Education for Chronic Venous Insufficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests a structured home-based exercise and education program added to usual care for adults with chronic venous insufficiency. Participants are randomized to either receive the program plus standard care or standard care with routine lifestyle advice. The primary questions are whether the program improves quality of life and reduces leg symptoms after 8 weeks and whether any benefits persist at 12 weeks. About 120 participants will be enrolled with 1:1 randomization and allocation managed by a designated nurse to ensure concealment. The intervention emphasizes supervised home-based exercises and education, while the control group receives standard medical care alone.

Why it matters

Who can join: the full rules

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

Where it's running

• Bolu Abant Izzet Baysal University
  Bolu, Bolu, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Alp Özel, PhD — Abant Izzet Baysal University
• Study coordinator: Alp Özel, PhD
• Email: alpozel@ibu.edu.tr
• Phone: +903742534520

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.