Investigating the Effectiveness of Progressive Resistance Exercise Training in the Management of Lymphedema Developing After Breast Cancer Treatment: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Uskudar University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- LYMphedema Quality of Life
Overview
Brief Summary
This study aims to investigate the effect of progressive resistance exercise training on the clinical findings and functional outcomes of lymphedema in individuals who develop upper extremity lymphedema after breast cancer treatment (surgery, chemotherapy and/or radiotherapy).
Detailed Description
The study is designed as a randomized controlled trial. Volunteers participating in the study will consist of individuals who have developed lymphedema after breast cancer and who agree to participate in the study. Volunteer female participants will be divided into 2 groups of equal numbers. Participants in the control group will receive lymphedema treatment, while participants in the exercise group will perform progressive resistance upper extremity exercises at home, 2 days a week for 12 weeks. All exercises will be performed with compression bandages. All participants will be evaluated before and after treatment using a hand dynamometer, the Disabilities of the Arm, Shoulder and Hand Scale, and the Lymphedema Quality of Life Questionnaire-Arm.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Being between 18 and 60 years of age.
- •Being included in the study 3 months after undergoing surgery.
- •Being able to tolerate compression bandages or compression garments.
Exclusion Criteria
- •\- Individuals who need to restart active cancer treatment during the study period. - Being within the first 3 months after surgery.
Arms & Interventions
control group
They will receive classic lymphedema physiotherapy.
Intervention: control (Other)
exercise group
In addition to classic lymphedema physiotherapy, a progressive resistance exercise training program will be implemented.
Intervention: control (Other)
exercise group
In addition to classic lymphedema physiotherapy, a progressive resistance exercise training program will be implemented.
Intervention: exercise (Other)
Outcomes
Primary Outcomes
LYMphedema Quality of Life
Time Frame: 14 weeks
The Lymphedema Quality of Life Questionnaire, a validated disease-specific QoL tool, was also administered at baseline and at day 28. Overall QoL is scored on a single item by the patient on a scale of 1-10.
Disabilities of the Arm, Shoulder and Hand
Time Frame: 14 weeks
Validated outcome measure that asks an individual to self-report about the ability to perform certain upper limb activities. Questions are responded on a 5-point Likert scale.
Secondary Outcomes
No secondary outcomes reported
Investigators
Doç.Dr.Ömer Şevgin
Assoc.Prof.Dr.
Uskudar University