Chronic Venous Insufficiency, CVI
Conditions
Keywords
Chronic Venous Disease, Home-Based Exercise, Exercise Therapy, Patient Education, Quality of Life, Venous Symptoms, Exercise Adherence
Brief summary
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.
Detailed description
The sample size was calculated using R version 4.5.3 with the pwr package. Previously published VEINES-QOL change data suggested a standardized effect size of approximately 0.72. However, because this estimate was derived from a single small study with very low-certainty evidence, a more conservative effect size of Cohen's d = 0.55 was prespecified. For a two-sided independent-samples comparison with a significance level of 0.05 and 80% statistical power, 53 participants were required in each group (106 participants in total). The target enrollment was increased to 120 participants to allow for potential attrition. The allocation sequence will be generated before participant enrollment by a staff nurse designated to manage the allocation process, using a prespecified script based on the blockrand package in R version 4.5.3, with a 1:1 allocation ratio and randomly varying block sizes. The designated staff nurse will otherwise not be involved in eligibility assessment, participant enrollment, intervention delivery, or outcome assessment. The sequence will be maintained in a password-protected electronic allocation system accessible only to the designated staff nurse. After eligibility has been confirmed, written informed consent has been obtained, and baseline assessments have been completed, the enrolling researcher will submit the participant's unique study identification number for allocation. The system will release only the assignment for the current participant, while future assignments will remain concealed. Repeated-measures data will be analyzed using linear mixed-effects models. Group, time, and the group-by-time interaction will be included as fixed effects, with participant-specific random effects included as appropriate. Statistical tests will be two-sided, with the significance level set at 0.05.
Interventions
BEHAVIORALStructured Home-Based Exercise and Education Program
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.
OTHERStandard Care (in control arm)
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.
Sponsors
Abant Izzet Baysal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Two-arm, parallel-group randomized controlled trial with a 1:1 allocation ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in VEINES-QOL Score | Baseline, Week 8, and Week 12 | 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. |
| Change in VEINES-Sym Score | Baseline, Week 8, and Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Six-Minute Walk Distance | Baseline, Week 8, and Week 12 | 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. |
| Change in Heel Rise Test Repetitions | Baseline, Week 8, and Week 12 | 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. |
| Change in IPAQ-SF Total Physical Activity | Baseline, Week 8, and Week 12 | 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. |
| Change in Pain Intensity | Baseline, Week 8, and Week 12 | 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. |
| Change in Lower-Extremity Heaviness | Baseline, Week 8, and Week 12 | Perceived lower-extremity heaviness will be assessed using a 100-mm Visual Analog Scale (VAS), with anchors of 0 mm indicating no heaviness and 100 mm indicating the most severe heaviness. Higher scores indicate greater symptom severity. Change from baseline will be evaluated at Weeks 8 and 12; a reduction in the score indicates improvement. |
| Change in Lower-Extremity Volume | Baseline, Week 8, and Week 12 | Lower-extremity volume will be estimated from serial circumference measurements using the truncated-cone method. The index limb will be selected before randomization: the affected limb in unilateral disease, the limb with the higher CEAP class in bilateral disease, or the right limb if CEAP classes are equal. With the participant standing, circumferences will be measured using a non-elastic tape from 4 cm above the floor proximally at 4-cm intervals to just below the knee joint line. If the final interval is shorter than 4 cm, its actual length will be used. Segment volumes will be calculated and summed to obtain total volume in milliliters. The same limb and measurement levels will be used at all visits. Higher values indicate greater edema. Change from baseline will be assessed at Weeks 8 and 12; a reduction indicates improvement. |
| Exercise Adherence Rate | Throughout the 8-week intervention period. | Exercise adherence will be assessed in the experimental group using daily exercise logs reviewed during weekly telephone calls or text-message follow-ups. An exercise day will be considered completed when the participant reports performing the prescribed home-based program for at least 20 minutes. The adherence rate will be calculated as the number of completed exercise days divided by 40 prescribed exercise days (5 days per week for 8 weeks), multiplied by 100. Values will range from 0% to 100%, with higher percentages indicating greater adherence. |
Countries
Turkey (Türkiye)
Contacts
CONTACTAlp Özel, PhD
PRINCIPAL_INVESTIGATORAlp Özel, PhD
Abant Izzet Baysal University
Outcome results
None listed