Inspiratory Muscle Training Versus Calf Muscle on Venous Function

Not Applicable

• Conditions: Venous Insufficiency
• Interventions: Other: exercise therapy

• Registration Number: NCT04215133
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-03
• Study First Submitted: 2019-12-25
• Study First Submitted QC: 2019-12-28
• Study First Posted: 2020-01-02
• Status Verified: 2021-05
• Primary Completion: 2021-05-14
• Last Update Submitted: 2021-05-14
• Last Update Posted: 2021-05-18
• Study Completion: 2021-05-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
İnspiratory muscle training group	exercise therapy	-
Calf muscle training group	exercise therapy	-

Primary Outcome Measures

Name	Time	Method
Photoplethysmograph (PPG)	12 months	venous return time
The Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20)	12 months	Quality of life

Secondary Outcome Measures

Name	Time	Method
Hand held dynamometer	12 months	muscle strength
visual analog scale	12 months	pain
6 minutes walk test	12 months	functional capacity
digital goniometer	12 months	range of motion of ankle
Venous Clinical Severity Score (VCSS)	12 months	clinical severity

Trial Locations

Locations (1)

Istanbul University Cerrahpasa; 🇹🇷 İstanbul, Turkey