Clinical trial NCT06521268: Effects of Inspiratory Muscle Training on Lymphedema
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lymphedema
Keywords: Lymphedema
Inspiratory muscle training
Decongestive treatment
Physical functioning
Sleep quality
Quality of life
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Volumetric Measurement
timeFrame: baseline and immediately after the intervention (in the 5th week)
measure: Measurement of Subcutaneous Tissue Thickness with Ultrasound (US)
timeFrame: baseline and immediately after the intervention (in the 5th week)
Secondary outcomes:
measure: VISUAL ANALOG SCALE-VAS
timeFrame: baseline and immediately after the intervention (in the 5th week)
measure: HAND DYNAMOMETER
timeFrame: baseline and immediately after the intervention (in the 5th week)
measure: Quick Disabilities Of the Arm,Shoulder And Hand (Quick DASH)
timeFrame: baseline and immediately after the intervention (in the 5th week)
measure: Respiratory Function Test
timeFrame: before and after the intervention (in the 5th week)
measure: Intraoral pressure measure
timeFrame: before and after the intervention (in the 5th week)
measure: Lymphedema Life Impact Scale - LLIS
timeFrame: before and after the intervention (in the 5th week)
measure: Lymph-ICF
timeFrame: before and after the intervention (in the 5th week)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: before and after the intervention (in the 5th week)
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Faculty of Health Sciences in Biruni University
state: Zeytinburnu
Study officials:
affiliation: Biruni University
name: UGUR CAVLAK, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.