Inspiratory Muscle Training Versus Calf Muscle on Venous Function

Inspiratory Muscle Training Versus Calf Muscle on Venous Function in Patients With Chronic Venous Insufficiency

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 Overview

• Status: Recruiting
• Conditions: Venous Insufficiency
• Intervention / Treatment: Other: exercise therapy

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GAMZE AYDIN, MSc; Phone Number: +905377600256; Email: gmzetsn@gmail.com

Study Locations

• Turkey
  • İstanbul, Turkey, 34959
    • Recruiting
    • Istanbul University Cerrahpasa
    • Contact: GAMZE AYDIN; Phone Number: 05377600256; Email: gmzetsn@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: İnspiratory muscle training group	Other: exercise therapy; inspiratory muscle training consists of strengthening exercise with threshold Inspiratory muscle training device and calf muscle training consist of isotonic and isometric strengthening exercise for calf muscle. All groups will receive compression therapy at the same time.
Experimental: Calf muscle training group	Other: exercise therapy; inspiratory muscle training consists of strengthening exercise with threshold Inspiratory muscle training device and calf muscle training consist of isotonic and isometric strengthening exercise for calf muscle. All groups will receive compression therapy at the same time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20)	Quality of life	12 months
Photoplethysmograph (PPG)	venous return time	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

General Publications

• Aydin G, Yeldan I, Akgul A, Ipek G. Effects of inspiratory muscle training versus calf muscle training on quality of life, pain, venous function and activity in patients with chronic venous insufficiency. J Vasc Surg Venous Lymphat Disord. 2022 Sep;10(5):1137-1146. doi: 10.1016/j.jvsv.2022.04.012. Epub 2022 Jun 14.

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2019
• Primary Completion (Actual): May 14, 2021
• Study Completion (Anticipated): May 20, 2021

Study Registration Dates

• First Submitted: December 25, 2019
• First Submitted That Met QC Criteria: December 28, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: exercise therapy; venous insufficiency; venous return; inspiratory muscle; kalf muscle
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Venous Insufficiency
• Other Study ID Numbers: IstanbulUCe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No