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)
1 other identifier
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 16, 2015
CompletedFirst Posted
Study publicly available on registry
August 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedMarch 23, 2021
March 1, 2021
2.1 years
July 16, 2015
March 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Arm circumference measurement
20 weeks
Extent of lymphoedema
20 weeks
Self-reported lymphoedema symptoms survey
20 weeks
Hand grip strength
20 weeks
Upper limb range of motion measurement
20 weeks
- +1 more secondary outcomes
Study Arms (2)
Exercise Group
EXPERIMENTALThe 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 INTERVENTIONThe control group will receive no exercise training and continue to receive standard medical care.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- active breast cancer
- have bilateral lymphedema or unstable lymphedema
- have musculoskeletal, cardiovascular and/ or neurological disorders that could inhibit them from exercising.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate
Study Record Dates
First Submitted
July 16, 2015
First Posted
August 19, 2015
Study Start
July 1, 2015
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
March 23, 2021
Record last verified: 2021-03