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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Inspiratory muscle training |
|
| Group 2 | Active Comparator | Controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory muscle training | Other | Inspiratory muscle training |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline and immediately after the intervention (in the 5th week) |
| HAND DYNAMOMETER |
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Inclusion Criteria:
Having been diagnosed with lymphedema in the upper extremity at least 6 months ago
Exclusion Criteria:
Having stage 1 and stage 3 lymphedema
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| Name | Affiliation | Role |
|---|---|---|
| UGUR CAVLAK, Prof. | Biruni University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Health Sciences in Biruni University | Istanbul | Zeytinburnu | 34010 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24283509 | Result | 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. |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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randomized controlled study
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| Decongestive treatment | Other | Decongestive treatment |
|
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) | 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 | to measure respiratory parameters (FEV1, FVC- higher score means better) | before and after the intervention (in the 5th week) |
| Intraoral pressure measure | 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 | 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 | 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) | 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) |
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |