Inspiratory Muscle Training Versus Calf Muscle on Venous Function

NCT ID: NCT04215133

Last Updated: 2021-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-03

Study Completion Date

2021-05-20

Brief Summary

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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

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Conditions

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Venous Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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İnspiratory muscle training group

Group Type EXPERIMENTAL

exercise therapy

Intervention Type OTHER

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.

Calf muscle training group

Group Type EXPERIMENTAL

exercise therapy

Intervention Type OTHER

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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Gamze Aydin

Principal İnvestigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul University Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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GAMZE AYDIN, MSc

Role: CONTACT

+905377600256

Facility Contacts

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GAMZE AYDIN

Role: primary

05377600256

References

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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.

Reference Type DERIVED
PMID: 35710091 (View on PubMed)

Other Identifiers

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IstanbulUCe

Identifier Type: -

Identifier Source: org_study_id

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