Inspiratory Muscle Training Versus Calf Muscle on Venous Function

Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04215133
• Other study ID #: IstanbulUCe
• Status: Recruiting
• Phase: N/A
• Start date: July 3, 2019
• Est. completion date: May 20, 2021

Study information

• Verified date: May 2021
• Source: Istanbul University-Cerrahpasa
• Contact: GAMZE AYDIN, MSc
• Phone: +905377600256
• Email: gmzetsn[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: May 20, 2021
• Est. primary completion date: May 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Aspiration
• Venous Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istanbul University Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20)	Quality of life	12 months
Primary	Photoplethysmograph (PPG)	venous return time	12 months
Secondary	Hand held dynamometer	muscle strength	12 months
Secondary	Venous Clinical Severity Score (VCSS)	clinical severity	12 months
Secondary	6 minutes walk test	functional capacity	12 months
Secondary	digital goniometer	range of motion of ankle	12 months
Secondary	visual analog scale	pain	12 months