Effects of Inspiratory Muscle Training on Lymphedema

July 1, 2025 updated by: Ugur Cavlak, Biruni University

Effects of Inspiratory Muscle Training on Lymphedema Volume, Subcutaneous Tissue Thickness, Upper Extremity Functioning, Sleep Quality, and Quality of Life in Upper Extremity Lymphedema Treatment: a Randomized Controlled Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Zeytinburnu
      • İ̇stanbul, Zeytinburnu, Turkey, 34010
        • Faculty of Health Sciences in Biruni University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Inspiratory muscle training
Other: Inspiratory muscle training
Inspiratory muscle training
Other Names:
  • Muscle training
Other: Decongestive treatment
Decongestive treatment
Active Comparator: Group 2
Controls
Other: Decongestive treatment
Decongestive treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volumetric Measurement
Time Frame: baseline and immediately after the intervention (in the 5th week)
to measure volume of the upper extremity in milliliter (increased volume compared to the normal upper extremity- increased score means worse outcome)
baseline and immediately after the intervention (in the 5th week)
Measurement of Subcutaneous Tissue Thickness with Ultrasound (US)
Time Frame: baseline and immediately after the intervention (in the 5th week)
to measure thickness of the tissue (increased thickness compared to the normal upper extremity- increased score means worse outcome)
baseline and immediately after the intervention (in the 5th week)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VISUAL ANALOG SCALE-VAS
Time Frame: baseline and immediately after the intervention (in the 5th week)
to measure swelling feel, heaviness of edema, and tension of edema (min. score is 0- max.score is10: higher score means worse outcome)
baseline and immediately after the intervention (in the 5th week)
HAND DYNAMOMETER
Time Frame: baseline and immediately after the intervention (in the 5th week)
to measure hand grip (in Newton- higher score means better score)
baseline and immediately after the intervention (in the 5th week)
Quick Disabilities Of the Arm,Shoulder And Hand (Quick DASH)
Time Frame: baseline and immediately after the intervention (in the 5th week)
to measure physical functioning of upper extremities (min. scorre is 0-max.score is 100- higher score means worse outcome)
baseline and immediately after the intervention (in the 5th week)
Respiratory Function Test
Time Frame: before and after the intervention (in the 5th week)
to measure respiratory parameters (FEV1, FVC- higher score means better)
before and after the intervention (in the 5th week)
Intraoral pressure measure
Time Frame: before and after the intervention (in the 5th week)
to measure Intraoral Pressure parameters (MEP and MIP- higher score means better)
before and after the intervention (in the 5th week)
Lymphedema Life Impact Scale - LLIS
Time Frame: before and after the intervention (in the 5th week)
to measure impact of lymphedema on the survivors with lymphedema (min. score is 18 and max. score is 90- higher score means worse outcome)
before and after the intervention (in the 5th week)
Lymph-ICF
Time Frame: before and after the intervention (in the 5th week)
to describe Lymphoedema Functioning, Disability And Health status of the partifcipants (min. score is 0 and max. score is 290- higher score means worse outcome)
before and after the intervention (in the 5th week)
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: before and after the intervention (in the 5th week)
to measure sleep quality (min. score is 0 and max.score is 21 - higher score means worse outcome)
before and after the intervention (in the 5th week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biruni University

Investigators

  • Principal Investigator: UGUR CAVLAK, Prof., Biruni University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 15, 2027

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

July 1, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BiruniUnivers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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