LymphedemaNCT07448467
Investigation of the Effectiveness of Progressive Resistance Exercise Training in the Management of Lymphedema.
A study testing exercise in people with Lymphedema and Breast Cancer, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Lymphedema, Breast Cancer
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Mar 2026to 7 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Within the first 3 months after surgery
- Requiring reinitiation of active cancer treatment during the study period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Re-Heal Physiotherapist Sude BOYVADAOĞLU Healthy Living Center
Adana
About this study
Official title: Investigating the Effectiveness of Progressive Resistance Exercise Training in the Management of Lymphedema Developing After Breast Cancer Treatment: a Randomized Controlled Trial
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).
Read the 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.
- Conditions
- Lymphedema, Breast Cancer
- Being tested
- control, exercise
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlOther
Classic lymphedema physiotherapy will be applied.
exerciseOther
In addition to classic lymphedema physiotherapy, a progressive resistance exercise training program will be implemented.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | 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. Receives: Other: control |
| exercise group | Experimental | 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. Receives: Other: control; Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of excess limb volume
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.
Measured: Baseline and 12 weeks
Secondary outcomes (2)
LYMphedema Quality of Life
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.
Measured: Baseline and 12 weeks
Disabilities of the Arm, Shoulder and Hand
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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start6 Mar 2026
- Primary completion15 Jun 2026
- Study completion7 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doç.Dr.Ömer Şevgin, Uskudar University
- Investigators
- Sevinj RAFILI, Study chair, Uskudar UniversitySuzan Aydın, Study director, İstanbul Gelişim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448467
- Sponsor's protocol ID
- Uskudar96
- Status last verified
- Aug 2026
- First submitted
- 26 Feb 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The original contributions presented in this study are included in the article. Further inquiries can be directed to the corresponding author
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.
PubMed 41149475Shamsesfandabadi 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.
PubMed 40498485Xue 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.
PubMed 40859515
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effectiveness of Progressive Resistance Exercise Training in the Management of Lymphedema Developing After Breast Cancer Treatment: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07448467
- Acronym / sponsor ID
- Uskudar96
- Conditions
- Lymphedema, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 7 Aug 2026 (actual)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: controlClassic 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. |
| exercise group | Experimental | Other: control, Other: exerciseClassic 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Within the first 3 months after surgery
- Requiring reinitiation of active cancer treatment during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| controlClassic lymphedema physiotherapy will be applied. | Other | control group, exercise group |
| exerciseIn addition to classic lymphedema physiotherapy, a progressive resistance exercise training program will be implemented. | Other | exercise group |
Primary outcome
Percentage of excess limb volume
Time frame: 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.
2 secondary outcomes
LYMphedema Quality of Life
Time frame: Baseline and 12 weeks
Disabilities of the Arm, Shoulder and Hand
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 41149475Leon-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.
- Background: PubMed 40498485Shamsesfandabadi 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.
- Background: PubMed 40859515Xue 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.
- Individual participant dataSharing planned: No. The original contributions presented in this study are included in the article. Further inquiries can be directed to the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevinj RAFILI study chair
Uskudar University
Suzan Aydın study director
İstanbul Gelişim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Lymphedema and Breast Cancer, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of excess limb volume (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07448467, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.