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)

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).

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Lymphedema
• Intervention / Treatment: Other: Exercise training

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Group; 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.	Other: Exercise training; 8-week resistive exercise training
No Intervention: Control Group; The control group will receive no exercise training and continue to receive standard medical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brachial artery blood flow	Measured by a Doppler ultrasonic device with a linear probe	20 weeks
Tissue oxygenation	Measured by Near-infrared spectroscopy	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arm circumference measurement	Measured by tape measure at 10cm-interval from the ulnar styloid process	20 weeks
Extent of lymphoedema	Measured by bioelectrical impedance spectroscopy	20 weeks
Self-reported lymphoedema symptoms survey		20 weeks
Hand grip strength	Measured by hand grip dynamometer	20 weeks
Upper limb range of motion measurement	Measured shoulder range of motion with standard goniometer	20 weeks
Quality of life measures	Measured using Functional Assessment of Cancer Therapy - Breast Cancer Subscale (FACT-B) Questionnaire	20 weeks

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Queen Elizabeth Hospital, Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: July 16, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Exercise; tissue oxygenation; blood flow velocity; BCRL
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Lymphedema
• Other Study ID Numbers: BCRL-1