LymphedemaNCT02527889
The Effect of Resistive Exercise on Forearm Blood Flow and Tissue Oxygenation Among Breast Cancer Survivors With or at Risk for Breast Cancer-related Lymphoedema (BCRL)
A study testing Exercise training in people with Lymphedema and Breast Cancer, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The purpose of the study is to evaluate the effect of resistive exercise on forearm blood flow and tissue oxygenation among breast cancer survivors with or at risk for breast cancer-related lymphoedema (BCRL). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Lymphedema, Breast Cancer
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2015to Aug 2017
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female breast cancer survivors
- remained disease free, as defined by unremarkable clinical examination within recent 6 months, with a clinical diagnosis of stable lymphoedema and without lymphedema.
Who cannot join
- active breast cancer
- have bilateral lymphedema or unstable lymphedema
- have musculoskeletal, cardiovascular and/ or neurological disorders that could inhibit them from exercising.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to evaluate the effect of resistive exercise on forearm blood flow and tissue oxygenation among breast cancer survivors with or at risk for breast cancer-related lymphoedema (BCRL).
Read the detailed description
160 subjects who have a diagnosis of breast cancer , 80 with and 80 without BCRL, will be recruited. Eligible subjects are Chinese ethnicity female breast cancer survivors, aged younger than 70 years old and body mass index less than 30kg/m2, remained disease free with a clinical diagnosis of stable BCRL and without BCRL. Subjects will be excluded if they have bilateral or unstable BCRL, defined as significant changes to the arm or receiving intensive therapy (i.e. decongestive therapy or antibiotics for infection) within the past 3 months, or musculoskeletal, cardiovascular and/ or neurological disorders that could inhibit them from exercising.
Primary outcomes include brachial artery blood flow measured by a Doppler ultrasound device and tissue oxygenation measured by near-infrared spectroscopy (NIRS). Additional outcomes and measures include arm circumference measurement, bioelectrical impedance spectroscopy, self-reported lymphoedema symptoms survey, handgrip dynamometer strength testing, upper limb range of motion measurements and quality of life measures using Functional Assessment of Cancer Therapy-Breast Cancer subscale (FACT-B) questionnaire will be obtained.
All outcomes measures will be assessed on both affected and contralateral unaffected arms of all subjects at pre-exercise, immediately post-exercise and 3-month after exercise. Comparison of the baseline measurements between breast cancer survivors with and without BCRL will be obtained.
Subjects will be randomly assigned by computer programme to exercise group and control group. Randomization will be stratified by whether axillary dissection and/ or axilla radiotherapy was given or not. The exercise group will receive supervised resistive exercise programme. Subjects in the exercise group will attend small group-based exercise sessions twice a week for 8 weeks supervised by physiotherapists. The duration of each exercise session will last for approximately 1 hour. Prior to resistive exercises, the subjects will perform warm up with movements of large joints and shoulder girdle for 15 minutes. Resistive exercises will focus on the major muscle groups in the upper body. Loading of resistive exercises will be prescribed and progressed according to individual capacity reaching a level of moderate to high loading (6 -12 repetition maximum). The subjects will also be instructed to perform stretching exercises specific to the muscle groups trained after the session. Symptoms responses will be monitored using self-reported lymphoedema symptoms survey before and after each exercise session. Rate of perceived exertion will also be recorded immediately after each exercise session.
- Conditions
- Lymphedema, Breast Cancer
- Being tested
- Exercise training
- Keywords
- Exercise, blood flow velocity, tissue oxygenation, BCRL
- Medical subject headings
- Lymphedema, Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
8-week resistive exercise training
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | The exercise group will receive a supervised resistive exercise training. Subjects in the exercise group will attend small group-based exercise sessions twice a week for 8 weeks supervised by physiotherapists. Receives: Other: Exercise training |
| Control Group | No intervention | The control group will receive no exercise training and continue to receive standard medical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery blood flow
Measured by a Doppler ultrasonic device with a linear probe
Measured: 20 weeks
Tissue oxygenation
Measured by Near-infrared spectroscopy
Measured: 20 weeks
Secondary outcomes (6)
Arm circumference measurement
Measured by tape measure at 10cm-interval from the ulnar styloid process
Measured: 20 weeks
Extent of lymphoedema
Measured by bioelectrical impedance spectroscopy
Measured: 20 weeks
Self-reported lymphoedema symptoms survey
Measured: 20 weeks
Hand grip strength
Measured by hand grip dynamometer
Measured: 20 weeks
Upper limb range of motion measurement
Measured shoulder range of motion with standard goniometer
Measured: 20 weeks
Quality of life measures
Measured using Functional Assessment of Cancer Therapy - Breast Cancer Subscale (FACT-B) Questionnaire
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Elizabeth Hospital, Hong Kong
- Responsible party
- Principal investigator, Rufina Lau, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527889
- Sponsor's protocol ID
- BCRL-1
- Status last verified
- Mar 2021
- First submitted
- 16 Jul 2015
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Resistive Exercise on Forearm Blood Flow and Tissue Oxygenation Among Breast Cancer Survivors With or at Risk for Breast Cancer-related Lymphoedema (BCRL)
- ClinicalTrials.gov ID
- NCT02527889
- Acronym / sponsor ID
- BCRL-1
- Conditions
- Lymphedema, Breast Cancer
- Keywords
- Exercise, blood flow velocity, tissue oxygenation, BCRL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Queen Elizabeth Hospital, Hong Kong
- Study start
- Jul 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 19 Aug 2015 (estimated)
- 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.
The purpose of the study is to evaluate the effect of resistive exercise on forearm blood flow and tissue oxygenation among breast cancer survivors with or at risk for breast cancer-related lymphoedema (BCRL).
Detailed description
160 subjects who have a diagnosis of breast cancer , 80 with and 80 without BCRL, will be recruited. Eligible subjects are Chinese ethnicity female breast cancer survivors, aged younger than 70 years old and body mass index less than 30kg/m2, remained disease free with a clinical diagnosis of stable BCRL and without BCRL. Subjects will be excluded if they have bilateral or unstable BCRL, defined as significant changes to the arm or receiving intensive therapy (i.e. decongestive therapy or antibiotics for infection) within the past 3 months, or musculoskeletal, cardiovascular and/ or neurological disorders that could inhibit them from exercising.
Primary outcomes include brachial artery blood flow measured by a Doppler ultrasound device and tissue oxygenation measured by near-infrared spectroscopy (NIRS). Additional outcomes and measures include arm circumference measurement, bioelectrical impedance spectroscopy, self-reported lymphoedema symptoms survey, handgrip dynamometer strength testing, upper limb range of motion measurements and quality of life measures using Functional Assessment of Cancer Therapy-Breast Cancer subscale (FACT-B) questionnaire will be obtained.
All outcomes measures will be assessed on both affected and contralateral unaffected arms of all subjects at pre-exercise, immediately post-exercise and 3-month after exercise. Comparison of the baseline measurements between breast cancer survivors with and without BCRL will be obtained.
Subjects will be randomly assigned by computer programme to exercise group and control group. Randomization will be stratified by whether axillary dissection and/ or axilla radiotherapy was given or not. The exercise group will receive supervised resistive exercise programme. Subjects in the exercise group will attend small group-based exercise sessions twice a week for 8 weeks supervised by physiotherapists. The duration of each exercise session will last for approximately 1 hour. Prior to resistive exercises, the subjects will perform warm up with movements of large joints and shoulder girdle for 15 minutes. Resistive exercises will focus on the major muscle groups in the upper body. Loading of resistive exercises will be prescribed and progressed according to individual capacity reaching a level of moderate to high loading (6 -12 repetition maximum). The subjects will also be instructed to perform stretching exercises specific to the muscle groups trained after the session. Symptoms responses will be monitored using self-reported lymphoedema symptoms survey before and after each exercise session. Rate of perceived exertion will also be recorded immediately after each exercise session.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Exercise trainingThe exercise group will receive a supervised resistive exercise training. Subjects in the exercise group will attend small group-based exercise sessions twice a week for 8 weeks supervised by physiotherapists. |
| Control Group | No intervention | –The control group will receive no exercise training and continue to receive standard medical care. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- female breast cancer survivors
- remained disease free, as defined by unremarkable clinical examination within recent 6 months, with a clinical diagnosis of stable lymphoedema and without lymphedema.
Key exclusion criteria (3 listed)
- active breast cancer
- have bilateral lymphedema or unstable lymphedema
- have musculoskeletal, cardiovascular and/ or neurological disorders that could inhibit them from exercising.
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 |
|---|---|---|
| Exercise training8-week resistive exercise training | Other | Exercise Group |
Primary outcome
Brachial artery blood flow
Time frame: 20 weeks
Measured by a Doppler ultrasonic device with a linear probe
Tissue oxygenation
Time frame: 20 weeks
Measured by Near-infrared spectroscopy
6 secondary outcomes
Arm circumference measurement
Time frame: 20 weeks
Extent of lymphoedema
Time frame: 20 weeks
Self-reported lymphoedema symptoms survey
Time frame: 20 weeks
Hand grip strength
Time frame: 20 weeks
Upper limb range of motion measurement
Time frame: 20 weeks
Quality of life measures
Time frame: 20 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 23 Mar 2021.
Related trials for Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Recruiting
Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer
Lymphedema Arm
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.
The record lists no contact. Use the official record to reach the sponsor.
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 training in people with Lymphedema and Breast Cancer, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 2 inclusion and 3 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 23 Mar 2021. 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 Hong Kong. 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?
Brachial artery blood flow (time frame: 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2021; AzTrials last refreshed its copy on 6 Nov 2026.