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

Lymphedema of Upper Limb Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05754346
• Other study ID #: bakircaymzeren07
• Status: Completed
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: Izmir Bakircay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema
• Lymphedema of Upper Limb
• Lymphedema, Breast Cancer

Intervention

Other:
• Complete Decongestive Therapy
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
"Upper-extremity exercises" component of Complete Decongestive Therapy will be performed combined with diaphragmatic breathing exercises.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (3)

Lead Sponsor	Collaborator
Izmir Bakircay University	Bezmialem Vakif University, Istanbul Kent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline lymphedema volume at 6th week	Arm volume will be measured using water displacement method.	6 weeks
Secondary	Change from baseline upper extremity pain at 6th week	Visual analog scale will be used for for quantifying pain.	6 weeks
Secondary	Change from baseline quality of life at 6th week	Quality of life will be evaluated using Lymphedema Functioning, Disability and Health Questionnaire for Upper Limb Lymphedema.	6 weeks