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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Hong Kong1 site
  • The Hong Kong Polytechnic University

    Hong Kong

Other trials in Hong Kong

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.

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.

Study groups in NCT02527889
Study groupRoleWhat they receive
Exercise GroupExperimentalThe 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 GroupNo interventionThe 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.

  1. Brachial artery blood flow

    Measured by a Doppler ultrasonic device with a linear probe

    Measured: 20 weeks

  2. Tissue oxygenation

    Measured by Near-infrared spectroscopy

    Measured: 20 weeks

Secondary outcomes (6)
  1. Arm circumference measurement

    Measured by tape measure at 10cm-interval from the ulnar styloid process

    Measured: 20 weeks

  2. Extent of lymphoedema

    Measured by bioelectrical impedance spectroscopy

    Measured: 20 weeks

  3. Self-reported lymphoedema symptoms survey

    Measured: 20 weeks

  4. Hand grip strength

    Measured by hand grip dynamometer

    Measured: 20 weeks

  5. Upper limb range of motion measurement

    Measured shoulder range of motion with standard goniometer

    Measured: 20 weeks

  6. 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.

  1. First posted19 Aug 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionAug 2017
  4. Study completionAug 2017

Resources

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)
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

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.

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