Structured Home-Based Exercise and Education for Chronic Venous Insufficiency

Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Structured Home-Based Exercise and Education GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Week 8, and Week 12
2

Change in VEINES-Sym Score

VEINES-Sym is the 10-item symptom summary score derived from the 26-item VEINES-QOL/Sym questionnaire. It assesses the frequency and severity of venous disease-related symptoms during the previous 4 weeks. Scores will be transformed to a 0-100 scale, with higher scores indicating fewer or less severe symptoms. Change from baseline will be calculated at Weeks 8 and 12; positive change values indicate symptom improvement.

Time frame
Baseline, Week 8, and Week 12

Secondary outcomes

1

Change in Six-Minute Walk Distance

The Six-Minute Walk Test will be used to assess submaximal functional exercise capacity. Participants will be instructed to walk as far as possible for 6 minutes along a flat corridor of at least 30 meters. The total distance walked will be recorded in meters. Change from baseline will be calculated at Weeks 8 and 12; positive change values indicate improvement in functional exercise capacity.

Time frame
Baseline, Week 8, and Week 12
2

Change in Heel Rise Test Repetitions

The Heel Rise Test will be used to assess calf muscle endurance and plantar flexor function. Participants will stand on one leg and perform as many heel-rise repetitions as possible according to a standardized protocol. The number of correctly completed repetitions will be recorded, and the same lower extremity will be assessed at each visit. Change from baseline will be calculated at Weeks 8 and 12; positive change values indicate improvement in calf muscle endurance.

Time frame
Baseline, Week 8, and Week 12
3

Change in IPAQ-SF Total Physical Activity

The International Physical Activity Questionnaire-Short Form (IPAQ-SF) is a 7-item self-report questionnaire that assesses physical activity performed during the previous 7 days. The reported frequency and duration of walking, moderate-intensity activity, and vigorous-intensity activity will be used to calculate total physical activity in metabolic equivalent minutes per week (MET-min/week) according to the IPAQ scoring protocol. Higher values indicate a greater level of physical activity. Change from baseline will be calculated at Weeks 8 and 12; positive change values indicate increased physical activity.

Time frame
Baseline, Week 8, and Week 12
4

Change in Pain Intensity

Lower-extremity pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), with anchors of 0 mm indicating no pain and 100 mm indicating the most severe pain. Higher scores indicate greater pain intensity. Change from baseline will be evaluated at Weeks 8 and 12; a reduction in the score indicates improvement.

Time frame
Baseline, Week 8, and Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.