Venous Insufficiency Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Bolu Abant Izzet Baysal University
RECRUITING
Bolu
Contact Information
Primary
Alp Özel, PhD
alpozel@ibu.edu.tr
+903742534520
Time Frame
Start Date: 2026-08-28
Estimated Completion Date: 2027-09-21
Participants
Target number of participants: 120
Treatments
Experimental: Structured Home-Based Exercise and Education Group
Participants 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.
Active_comparator: Control Group
Participants 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.
Related Therapeutic Areas
Sponsors
Leads: Abant Izzet Baysal University

This content was sourced from clinicaltrials.gov