Effects of Inspiratory Muscle Training on Lymphedema

NCT ID: NCT06521268

Last Updated: 2025-07-03

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2027-05-15

Brief Summary

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The aim of this study is to examine the effect of inspiratory muscle training on lymphedema volume, subcutaneous tissue thickness, upper extremity functionality and sleep quality in the treatment of upper extremity lymphedema. Two groups included 24 patients with lymphedema will be divided into gropus (intervetion and control) and they will compare each other.

Detailed Description

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All patients will be treated 5 days a week, 4 weeks, with each session lasting 45-60 minutes. While only decongestive treatment will be applied to the control group, inspiratory muscle training will be given to the interventional group in addition to decongestive treatment. Evaluations of the patients will be made before and after of 4-week treatment program.

Conditions

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Lymphedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1

Inspiratory muscle training

Group Type EXPERIMENTAL

Inspiratory muscle training

Intervention Type OTHER

Inspiratory muscle training

Decongestive treatment

Intervention Type OTHER

Decongestive treatment

Group 2

Controls

Group Type ACTIVE_COMPARATOR

Decongestive treatment

Intervention Type OTHER

Decongestive treatment

Interventions

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Inspiratory muscle training

Inspiratory muscle training

Intervention Type OTHER

Decongestive treatment

Decongestive treatment

Intervention Type OTHER

Other Intervention Names

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Muscle training

Eligibility Criteria

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Inclusion Criteria

Having been diagnosed with lymphedema in the upper extremity at least 6 months ago

* Having stage 2 lymphedema
* Having a 2-8 cm circumference difference between the affected extremity and the healthy extremity at any reference point
* Being between the ages of 18-60
* Voluntarily agreeing to participate in the study
* Not having received any lymphedema treatment in the last 6 months.
* Not having any physical, respiratory, neurological and/or systemic disease that would prevent participation in the treatment program.

Exclusion Criteria

Having stage 1 and stage 3 lymphedema

* It has been less than 6 months since the diagnosis of lymphedema was made
* Being under 18 years of age and over 60 years of age
* Having a circumference measurement difference of more than 8 cm and less than 2 cm at any reference point between the affected extremity and the healthy extremity
* Lymphedema or elephantiasis with papilloma, hyperkeratosis
* Uncontrolled hypertension, pulmonary edema, presence of serious cardiovascular disease
* Presence of active metastasis
* Acute inflammatory diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Biruni University

OTHER

Sponsor Role lead

Responsible Party

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Ugur Cavlak

CLINICAL PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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UGUR CAVLAK, Prof.

Role: PRINCIPAL_INVESTIGATOR

Biruni University

Locations

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Faculty of Health Sciences in Biruni University

Istanbul, Zeytinburnu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Hacard F, Machet L, Caille A, Tauveron V, Georgescou G, Rapeneau I, Samimi M, Patat F, Vaillant L. Measurement of skin thickness and skin elasticity to evaluate the effectiveness of intensive decongestive treatment in patients with lymphoedema: a prospective study. Skin Res Technol. 2014 Aug;20(3):274-81. doi: 10.1111/srt.12116. Epub 2013 Nov 27.

Reference Type RESULT
PMID: 24283509 (View on PubMed)

Other Identifiers

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BiruniUnivers

Identifier Type: -

Identifier Source: org_study_id

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