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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)

Primary Purpose

Lymphedema, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Exercise training
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lymphedema focused on measuring Exercise, blood flow velocity, tissue oxygenation, BCRL

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • active breast cancer
  • have bilateral lymphedema or unstable lymphedema
  • have musculoskeletal, cardiovascular and/ or neurological disorders that could inhibit them from exercising.

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise Group

Control Group

Arm Description

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.

The control group will receive no exercise training and continue to receive standard medical care.

Outcomes

Primary Outcome Measures

Brachial artery blood flow
Measured by a Doppler ultrasonic device with a linear probe
Tissue oxygenation
Measured by Near-infrared spectroscopy

Secondary Outcome Measures

Arm circumference measurement
Measured by tape measure at 10cm-interval from the ulnar styloid process
Extent of lymphoedema
Measured by bioelectrical impedance spectroscopy
Self-reported lymphoedema symptoms survey
Hand grip strength
Measured by hand grip dynamometer
Upper limb range of motion measurement
Measured shoulder range of motion with standard goniometer
Quality of life measures
Measured using Functional Assessment of Cancer Therapy - Breast Cancer Subscale (FACT-B) Questionnaire

Full Information

First Posted
July 16, 2015
Last Updated
March 22, 2021
Sponsor
The Hong Kong Polytechnic University
Collaborators
Queen Elizabeth Hospital, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02527889
Brief 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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Queen Elizabeth Hospital, Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Breast Cancer
Keywords
Exercise, blood flow velocity, tissue oxygenation, BCRL

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will receive no exercise training and continue to receive standard medical care.
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
8-week resistive exercise training
Primary Outcome Measure Information:
Title
Brachial artery blood flow
Description
Measured by a Doppler ultrasonic device with a linear probe
Time Frame
20 weeks
Title
Tissue oxygenation
Description
Measured by Near-infrared spectroscopy
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Arm circumference measurement
Description
Measured by tape measure at 10cm-interval from the ulnar styloid process
Time Frame
20 weeks
Title
Extent of lymphoedema
Description
Measured by bioelectrical impedance spectroscopy
Time Frame
20 weeks
Title
Self-reported lymphoedema symptoms survey
Time Frame
20 weeks
Title
Hand grip strength
Description
Measured by hand grip dynamometer
Time Frame
20 weeks
Title
Upper limb range of motion measurement
Description
Measured shoulder range of motion with standard goniometer
Time Frame
20 weeks
Title
Quality of life measures
Description
Measured using Functional Assessment of Cancer Therapy - Breast Cancer Subscale (FACT-B) Questionnaire
Time Frame
20 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: active breast cancer have bilateral lymphedema or unstable lymphedema have musculoskeletal, cardiovascular and/ or neurological disorders that could inhibit them from exercising.
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Learn more about this trial

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)

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