Does Inclusion of Diaphragmatic Breathing Exercises in Complete Decongestive Therapy Provide Further Benefits in Patients With Breast Cancer Related Lymphedema

NCT05754346 — Not applicable, Completed, 40 participants, Izmir Bakircay University

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Registry	NCT05754346
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	40 (Actual)
Sponsor	Izmir Bakircay University (Other); collaborators: Bezmialem Vakif University, Istanbul Kent University
Conditions	Lymphedema, Breast Cancer, Lymphedema of Upper Limb
Interventions	Complete Decongestive Therapy, Upper extremity exercises combined with diaphragmatic breathing exercises (Other)
Dates	start 2023-03-20, primary completion 2023-12-01, completion 2023-12-01, first posted 2023-03-03, last updated 2024-01-05
Locations	1 site in Turkey (Türkiye)

-Summary

Complete decongestive therapy is proven to be effective in reducing lymphedema related symptoms such as swelling and pain. Breathing exercises, on the other hand, may also help managing lymphedema symptoms. Deep breathing creates a pressure change in the abdomen, which creates a vacuum effect in the thoracic cavity and helps to empty the lymphatic vessels. Thus, we aimed to investigate whether addition of diaphragmatic breathing exercises to physical exercise component of complete decongestive therapy provides further benefits on lymphedema volume, pain and quality of life in patients with breast cancer related lymphedema.

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+Arms and interventions

Arm	Type	Interventions	Description
Control Group	Active comparator	Other: Complete Decongestive Therapy	Patients in this group will receive "Complete Decongestive Therapy" for 6 weeks. 1 session each week will be supervised in a clinic. Rest of the sessions will be performed at home.
Study Group	Experimental	Other: Complete Decongestive Therapy; Other: Upper extremity exercises combined with diaphragmatic breathing exercises	Patients in this group will receive "Complete Decongestive Therapy" combined with diaphragmatic breathing exercises for 6 weeks. 1 session each week will be supervised in a clinic. Rest of the sessions will be performed at home.

Complete Decongestive Therapy (Other): Complete Decongestive Therapy will include manual lymphedema drainage (self) for 20 min everyday, skin care everyday, wearing compression garment or bandages everyday and upper-extremity exercises twice a day.
Upper extremity exercises combined with diaphragmatic breathing exercises (Other): "Upper-extremity exercises" component of Complete Decongestive Therapy will be performed combined with diaphragmatic breathing exercises.

+Outcome measures

Primary outcomes

Change from baseline lymphedema volume at 6th week [6 weeks]: Arm volume will be measured using water displacement method.

Secondary outcomes

Change from baseline upper extremity pain at 6th week [6 weeks]: Visual analog scale will be used for for quantifying pain.
Change from baseline quality of life at 6th week [6 weeks]: Quality of life will be evaluated using Lymphedema Functioning, Disability and Health Questionnaire for Upper Limb Lymphedema.

+Eligibility

Sex: Female, ages: 25 Years to 65 Years

Inclusion Criteria:

* Diagnosis of arm lymphedema after being treated for unilateral breast cancer with axillary node dissection
* Completion of the treatments for the disease including chemotherapy and radiotherapy after breast surgery

Exclusion Criteria:

* Having recurrent cancer
* Having cognitive disability
* Having any concurrent diseases that may interfere with the measurement of lymphedema

+Locations (1)

Facility	City	Country	Status
Bezmialem Vakif University	Istanbul	Turkey (Türkiye)

+Investigators

Alis Kostanoglu, assoc.prof., Study director, Bezmialem Vakif University