Structured Home-Based Exercise and Education for Chronic Venous Insufficiency
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
2 other identifiers
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2026
CompletedFirst Posted
Study publicly available on registry
August 21, 2026
CompletedStudy Start
First participant enrolled
September 21, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2027
Study Completion
Last participant's last visit for all outcomes
September 21, 2027
August 26, 2026
August 1, 2026
1 year
August 18, 2026
August 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 12
Secondary Outcomes (7)
Change in Six-Minute Walk Distance
Baseline, Week 8, and Week 12
Change in Heel Rise Test Repetitions
Baseline, Week 8, and Week 12
Change in IPAQ-SF Total Physical Activity
Baseline, Week 8, and Week 12
Change in Pain Intensity
Baseline, Week 8, and Week 12
Change in Lower-Extremity Heaviness
Baseline, Week 8, and Week 12
- +2 more secondary outcomes
Study Arms (2)
Structured Home-Based Exercise and Education Group
EXPERIMENTALParticipants in this arm will continue their physician-prescribed standard medical treatment and receive a structured exercise and education program. The program will begin with a 30- to 45-minute face-to-face group session led by a physiotherapist. The session will include education about chronic venous insufficiency, leg elevation, physical activity, weight management, lifestyle recommendations, and compression stocking use when recommended by a physician. Participants will also receive instruction and supervised practice in ankle pumping, plantar flexion and dorsiflexion, heel raises, calf muscle activation, walking, and light stretching exercises. They will perform the exercise program at home for 20 to 30 minutes per day on at least 5 days per week for 8 weeks. Adherence and potential adverse symptoms will be monitored weekly by telephone call or text message and documented using a daily exercise log.
Control Group
ACTIVE COMPARATORParticipants assigned to this arm will continue their physician-prescribed standard medical treatment and receive routine lifestyle recommendations for the management of chronic venous insufficiency. They will not receive the structured group education session, study-specific home-based exercise program, or weekly adherence monitoring provided to the experimental group.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bolu Abant Izzet Baysal University
Bolu, Bolu, 14030, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alp Özel, PhD
Abant Izzet Baysal University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 18, 2026
First Posted
August 21, 2026
Study Start (Estimated)
September 21, 2026
Primary Completion (Estimated)
September 21, 2027
Study Completion (Estimated)
September 21, 2027
Last Updated
August 26, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will become available following publication of the primary study results and will remain available for 5 years.
- Access Criteria
- De-identified individual participant data and supporting documents will be made available to qualified researchers upon reasonable request to the principal investigator. Requests should include a research proposal describing the purpose of the planned analysis. Access will be granted for scientifically appropriate purposes, subject to applicable ethical and institutional requirements and a data use agreement where required.
De-identified individual participant data underlying the results reported in the primary publication will be shared. These data will include demographic and baseline clinical characteristics, allocated study group, VEINES-QOL and VEINES-Sym scores, Six-Minute Walk Test distance, Heel Rise Test repetitions, IPAQ-SF total physical activity, pain and lower-extremity heaviness scores, lower-extremity volume, exercise adherence, adverse events, withdrawal status, and outcome data collected at the relevant study time points. A data dictionary and coding guide will accompany the dataset. Direct identifiers and free-text information that could permit participant re-identification will not be shared. Only data from participants whose consent permits data sharing will be included.