Breast Cancer, Lymphedema
Conditions
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. Fifty women who developed unilateral upper-limb lymphoedema following breast cancer treatment were randomly allocated in a 1:1 ratio to an exercise group or a control group. Both groups received classic lymphoedema physiotherapy twice weekly for 12 weeks (24 sessions), comprising manual lymphatic drainage (30 minutes), multilayer short-stretch compression bandaging applied at the end of each session, simple lymphatic exercises (15 minutes), and structured skin-care education. Standard compression bandaging was used in both groups throughout the study period. In addition, participants in the exercise group performed a home-based progressive resistance exercise programme for the upper limb twice weekly on non-consecutive days for 12 weeks. Each session lasted 40 to 45 minutes and comprised a 10-minute warm-up, a 20- to 25-minute resistance component and a 10-minute cool-down. The resistance component consisted of eight exercises performed bilaterally using Thera-Band elastic resistance: shoulder flexion, shoulder abduction, shoulder external rotation, elbow flexion, elbow extension, wrist flexion, wrist extension, and scapular retraction and protraction, in three sets of ten repetitions each. Exercise intensity was prescribed by band colour and monitored using the Borg CR10 scale (target 4 to 6), and resistance was progressed by one band colour every four weeks. All sessions were performed while wearing the compression bandaging already in place as part of standard care. Adherence was monitored using a structured exercise log and telephone contact every 15 days. All participants were assessed at baseline and after 12 weeks by an outcome assessor blinded to group allocation.
Interventions
OTHERcontrol
Classic lymphedema physiotherapy will be applied.
OTHERexercise
In addition to classic lymphedema physiotherapy, a progressive resistance exercise training program will be implemented.
Sponsors
Uskudar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Female, aged 30 to 60 years * Unilateral upper-limb lymphoedema following treatment for breast cancer (surgery, chemotherapy and/or radiotherapy), diagnosed clinically by a physician * Excess limb volume of at least 10% relative to the unaffected limb, calculated from bilateral circumferential measurements using the truncated cone formula * At least 3 months post-surgery * Able to tolerate compression bandaging or a compression garment
Exclusion criteria
* Within the first 3 months after surgery * Requiring reinitiation of active cancer treatment during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of excess limb volume | Baseline and 12 weeks | Limb circumference measured with a flexible tape at 5 cm intervals from the ulnar styloid process to 40 cm proximally in both limbs. Segmental volumes calculated using the truncated cone formula and summed. Excess volume expressed as the percentage difference between the affected and unaffected limb relative to the unaffected limb volume. A lower value indicates less lymphoedema. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LYMphedema Quality of Life | Baseline and 12 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 | Baseline and 12 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. |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRSevinj RAFILI
Uskudar University
STUDY_DIRECTORSuzan Aydın
İstanbul Gelişim University
Outcome results
None listed