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Inspiratory Muscle Training Versus Calf Muscle on Venous Function

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04215133
Enrollment
42
Registered
2020-01-02
Start date
2019-07-03
Completion date
2021-05-20
Last updated
2021-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Insufficiency

Keywords

venous insufficiency, exercise therapy, inspiratory muscle, kalf muscle, venous return

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.

Interventions

OTHERexercise 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.

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Photoplethysmograph (PPG)12 monthsvenous return time
The Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20)12 monthsQuality of life

Secondary

MeasureTime frameDescription
6 minutes walk test12 monthsfunctional capacity
Hand held dynamometer12 monthsmuscle strength
visual analog scale12 monthspain
digital goniometer12 monthsrange of motion of ankle
Venous Clinical Severity Score (VCSS)12 monthsclinical severity

Countries

Turkey (Türkiye)

Contacts

Primary ContactGAMZE AYDIN, MSc
gmzetsn@gmail.com+905377600256

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026