Effects of Inspiratory Muscle Training on Lymphedema

Not Applicable

Not yet recruiting

• Conditions: Lymphedema
• Interventions: Other: Decongestive treatment; Other: Inspiratory muscle training

• Registration Number: NCT06521268
• Lead Sponsor: Biruni University

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-24
• Study First Posted: 2024-07-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-30
• Study Start: 2025-04-10
• Primary Completion: 2025-12-01
• Study Completion: 2026-05-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Decongestive treatment	Controls
Group 1	Decongestive treatment	Inspiratory muscle training
Group 1	Inspiratory muscle training	Inspiratory muscle training

Primary Outcome Measures

Name	Time	Method
Volumetric Measurement	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)
Measurement of Subcutaneous Tissue Thickness with Ultrasound (US)	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)

Secondary Outcome Measures

Name	Time	Method
VISUAL ANALOG SCALE-VAS	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)
Intraoral pressure measure	before and after the intervention (in the 5th week)	to measure Intraoral Pressure parameters (MEP and MIP- higher score means better)
Quick Disabilities Of the Arm,Shoulder And Hand (Quick DASH)	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)
Lymph-ICF	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)
Respiratory Function Test	before and after the intervention (in the 5th week)	to measure respiratory parameters (FEV1, FVC- higher score means better)
Lymphedema Life Impact Scale - LLIS	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)
HAND DYNAMOMETER	baseline and immediately after the intervention (in the 5th week)	to measure hand grip (in Newton- higher score means better score)
Pittsburgh Sleep Quality Index (PSQI)	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)

Trial Locations

Locations (1)

Faculty of Health Sciences in Biruni University; 🇹🇷 İ̇stanbul, Zeytinburnu, Turkey