Effects of Inspiratory Muscle Training on Lymphedema

NCT06521268 | Active Not Recruiting

• 1 other identifier: BiruniUnivers
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema

Keywords

Lymphedema; Inspiratory muscle training; Decongestive treatment; Physical functioning; Sleep quality; Quality of life

Outcome Measures

Primary Outcomes (2)

• Volumetric Measurement

  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)

  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 Outcomes (8)

• VISUAL ANALOG SCALE-VAS

  baseline and immediately after the intervention (in the 5th week)

• HAND DYNAMOMETER

  baseline and immediately after the intervention (in the 5th week)

• Quick Disabilities Of the Arm,Shoulder And Hand (Quick DASH)

  baseline and immediately after the intervention (in the 5th week)

• Respiratory Function Test

  before and after the intervention (in the 5th week)

• Intraoral pressure measure

  before and after the intervention (in the 5th week)

Study Arms (2)

Group 1

EXPERIMENTAL

Inspiratory muscle training

Other: Inspiratory muscle training; Other: Decongestive treatment

Group 2

ACTIVE COMPARATOR

Controls

Other: Decongestive treatment

Interventions

Inspiratory muscle training OTHER

Inspiratory muscle training

Also known as: Muscle training

Group 1

Decongestive treatment OTHER

Decongestive treatment

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Faculty of Health Sciences in Biruni University

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 24283509 RESULT

MeSH Terms

Conditions

Lymphedema; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• UGUR CAVLAK, Prof.

  Biruni University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CLINICAL PROFESSOR

Model Details: randomized controlled study

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 25, 2024
• Study Start: July 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 15, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)