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)

NCT ID: NCT02527889

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-08-31

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.

Conditions

Lymphedema; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: OTHER

8-week resistive exercise training

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise training

8-week resistive exercise training

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Queen Elizabeth Hospital, Hong Kong

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Rufina Lau

Clinical Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

BCRL-1

Identifier Type: -

Identifier Source: org_study_id