Clinical trial NCT04215133: Inspiratory Muscle Training Versus Calf Muscle on Venous Function
Official title: Inspiratory Muscle Training Versus Calf Muscle on Venous Function in Patients With Chronic Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Insufficiency
Keywords: venous insufficiency
exercise therapy
inspiratory muscle
kalf muscle
venous return
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20)
timeFrame: 12 months
measure: Photoplethysmograph (PPG)
timeFrame: 12 months
Secondary outcomes:
measure: Hand held dynamometer
timeFrame: 12 months
measure: Venous Clinical Severity Score (VCSS)
timeFrame: 12 months
measure: 6 minutes walk test
timeFrame: 12 months
measure: digital goniometer
timeFrame: 12 months
measure: visual analog scale
timeFrame: 12 months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul University Cerrahpasa
Study officials:
References:
citation: 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.