Structured Home-Based Exercise and Education for Chronic Venous Insufficiency

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbant Izzet Baysal University

About this 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.

Eligibility criteria

Qualifiers

Aged 18 years or older

Physician-confirmed diagnosis of chronic venous insufficiency

CEAP clinical class C1-C4

Ability to walk independently

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Structured Home-Based Exercise and Education Program
  • Standard Care (in control arm)

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators