Inspiratory Muscle Training Versus Calf Muscle on Venous Function in Patients With Chronic Venous Insufficiency
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- The Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20)
Study Overview
Brief Summary
The aim of this study was to evaluate the effect of exercise training in addition to compression therapy on quality of life, venous return time, muscle strength, clinical severity, functional capacity in venous insufficiency compared to compression treatment alone. Fourty-two volunteer patients with venous insufficiency will include in the study were randomly divided into three groups as inspiratory exercise, calf muscle exercise and control. While the control group will receive only compression therapy, the inspiratory exercise group will apply inspiratory muscle training consisted of strengthening exercise in addition to compression therapy; kalf muscle exercise group will apply strengthening exercise for calf muscle in addition to compression therapy for 2 days/week with physiotherapist and 3 days/week by themselves, 8 weeks. All the patients will assess with Chronic Venous Disease Quality of life Questionnaire-20 (CIVIQ-20), Nottingham Health Profile, Photopletismograph, Venous Clinical Severity Score (VCSS), hand-held dynamometer, Visual Analogue Scale (VAS), circumference measurements, 6-minute walk test (6MWT), before and after the treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Diagnosis of venous insufficiency between 18-75 years with duplex ultrasound imaging
- •CEAP classification used in venous insufficiency is C2-C3-C4-C5
- •Having written and verbal communication in Turkish
Exclusion Criteria
- •Acute deep vein thrombosis
- •The presence of ulceration
- •Being in class III and IV according to the New York Heart Association classification
- •Presence of respiratory failure
- •Undergoing chemotherapy due to the presence of any cancer
- •Being in the process of treatment for neurological, orthopedic or rheumatologic diseases including lower extremity
Arms & Interventions
Calf muscle training group
Intervention: exercise therapy (Other)
Control
İnspiratory muscle training group
Intervention: exercise therapy (Other)
Outcomes
Primary Outcomes
The Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20)
Time Frame: 12 months
Quality of life
Photoplethysmograph (PPG)
Time Frame: 12 months
venous return time
Secondary Outcomes
- digital goniometer(12 months)
- Hand held dynamometer(12 months)
- visual analog scale(12 months)
- Venous Clinical Severity Score (VCSS)(12 months)
- 6 minutes walk test(12 months)
Investigators
Gamze Aydin
Principal İnvestigator
Istanbul University - Cerrahpasa (IUC)