LymphedemaNCT06521268
Effects of Inspiratory Muscle Training on Lymphedema
A study testing Inspiratory muscle training and Decongestive treatment in people with Lymphedema, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- Inspiratory muscle training and Decongestive treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 15 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences in Biruni University
Istanbul, Zeytinburnu, 34010
About this study
Official 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
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.
Read the 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.
- Conditions
- Lymphedema
- Being tested
- Inspiratory muscle training, Decongestive treatment
- Keywords
- Lymphedema, Inspiratory muscle training, Decongestive treatment, Physical functioning, Sleep quality, Quality of life
- Medical subject headings
- Lymphedema, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
Also called Muscle training
Inspiratory muscle training
Decongestive treatmentOther
Decongestive treatment
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Inspiratory muscle training Receives: Other: Inspiratory muscle training; Other: Decongestive treatment |
| Group 2 | Active comparator | Controls Receives: Other: Decongestive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric Measurement
to measure volume of the upper extremity in milliliter (increased volume compared to the normal upper extremity- increased score means worse outcome)
Measured: 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)
Measured: baseline and immediately after the intervention (in the 5th week)
Secondary outcomes (8)
VISUAL ANALOG SCALE-VAS
to measure swelling feel, heaviness of edema, and tension of edema (min. score is 0- max.score is10: higher score means worse outcome)
Measured: baseline and immediately after the intervention (in the 5th week)
HAND DYNAMOMETER
to measure hand grip (in Newton- higher score means better score)
Measured: baseline and immediately after the intervention (in the 5th week)
Quick Disabilities Of the Arm,Shoulder And Hand (Quick DASH)
to measure physical functioning of upper extremities (min. scorre is 0-max.score is 100- higher score means worse outcome)
Measured: baseline and immediately after the intervention (in the 5th week)
Respiratory Function Test
to measure respiratory parameters (FEV1, FVC- higher score means better)
Measured: before and after the intervention (in the 5th week)
Intraoral pressure measure
to measure Intraoral Pressure parameters (MEP and MIP- higher score means better)
Measured: before and after the intervention (in the 5th week)
Lymphedema Life Impact Scale - LLIS
to measure impact of lymphedema on the survivors with lymphedema (min. score is 18 and max. score is 90- higher score means worse outcome)
Measured: before and after the intervention (in the 5th week)
Lymph-ICF
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)
Measured: before and after the intervention (in the 5th week)
Pittsburgh Sleep Quality Index (PSQI)
to measure sleep quality (min. score is 0 and max.score is 21 - higher score means worse outcome)
Measured: before and after the intervention (in the 5th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Jul 2025
- Primary completion1 May 2026 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ugur Cavlak, Biruni University
- Investigators
- UGUR CAVLAK, Prof., Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521268
- Sponsor's protocol ID
- BiruniUnivers
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24283509
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06521268
- Acronym / sponsor ID
- BiruniUnivers
- Conditions
- Lymphedema
- Keywords
- Lymphedema, Inspiratory muscle training, Decongestive treatment, Physical functioning, Sleep quality, Quality of life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Inspiratory muscle training, Other: Decongestive treatmentInspiratory muscle training |
| Group 2 | Active comparator | Other: Decongestive treatmentControls |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle trainingAlso: Muscle trainingInspiratory muscle training | Other | Group 1 |
| Decongestive treatmentDecongestive treatment | Other | Group 1, Group 2 |
Primary outcome
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)
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)
8 secondary outcomes
VISUAL ANALOG SCALE-VAS
Time frame: baseline and immediately after the intervention (in the 5th week)
HAND DYNAMOMETER
Time frame: 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)
Respiratory Function Test
Time frame: before and after the intervention (in the 5th week)
Intraoral pressure measure
Time frame: 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)
Lymph-ICF
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Results publication: PubMed 24283509Hacard 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.
- Individual participant dataSharing planned: No
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Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
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A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
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Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UGUR CAVLAK, Prof. principal investigator
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training and Decongestive treatment in people with Lymphedema, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric Measurement (time frame: baseline and immediately after the intervention (in the 5th week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06521268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.