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NCT Number: NCT06521268

Effects of Inspiratory Muscle Training on Lymphedema

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lymphedema Dyssomnias Hemic and Lymphatic Diseases Lymphatic Diseases Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Sciences in Biruni University

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory Muscle Training

Other

Inspiratory muscle training

Other names: Muscle training

Decongestive treatment

Other

Decongestive treatment

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. Respiratory Function Test

    Time frame: before and after the intervention (in the 5th week)

    to measure respiratory parameters (FEV1, FVC- higher score means better)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 25, 2024
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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