Investigation of the Effectiveness of Progressive Resistance Exercise Training in the Management of Lymphedema.
Investigating the Effectiveness of Progressive Resistance Exercise Training in the Management of Lymphedema Developing After Breast Cancer Treatment: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Adana, Turkey (Türkiye)
- Re-Heal Physiotherapist Sude BOYVADAOĞLU Healthy Living Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: control group
Classic lymphoedema physiotherapy alone, twice weekly for 12 weeks (24 sessions): manual lymphatic drainage (30 min), multilayer short-stretch compression bandaging, simple lymphatic exercises (15 min) and skin-care education.
No resistance exercise programme was prescribed.
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Classic lymphedema physiotherapy will be applied.
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Experimental: exercise group
Classic lymphoedema physiotherapy as in the control group, plus a home-based progressive resistance exercise programme for the upper limb, twice weekly for 12 weeks (24 sessions), using Thera-Band elastic resistance with band-colour progression every four weeks.
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Classic lymphedema physiotherapy will be applied.
In addition to classic lymphedema physiotherapy, a progressive resistance exercise training program will be implemented.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of excess limb volume
Time Frame: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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LYMphedema Quality of Life
Time Frame: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Disabilities of the Arm, Shoulder and Hand
Time Frame: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Sevinj RAFILI, Uskudar University
- Study Director: Suzan Aydın, İstanbul Gelisim University
Publications and helpful links
General Publications
- Leon-Diaz R, Medina-Otero A. Prevention and Treatment of Postmastectomy Lymphedema: A Physiotherapy Perspective. Curr Oncol. 2025 Oct 3;32(10):555. doi: 10.3390/curroncol32100555.
- Shamsesfandabadi P, Shams Esfand Abadi M, Yin Y, Carpenter DJ, Peluso C, Hilton C, Coopey SB, Gomez J, Beriwal S, Champ CE. Resistance Training and Lymphedema in Breast Cancer Survivors. JAMA Netw Open. 2025 Jun 2;8(6):e2514765. doi: 10.1001/jamanetworkopen.2025.14765.
- Xue T, Zhang L, Zhang D. Exercise-based interventions for postoperative rehabilitation in breast cancer patients: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2025 Aug 22;104(34):e43705. doi: 10.1097/MD.0000000000043705.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uskudar96
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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