Efficacy of Cardio-Oncology Rehabilitation Exercise for Women With Breast Cancer and Treatment Related Cardiotoxicity (CORE)
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|ClinicalTrials.gov Identifier: NCT03089502|
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : October 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Left Ventricular Dysfunction Heart Failure, Systolic||Other: Exercise Rehabilitation||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Control Trial of the Efficacy of a Cardio-Oncology Rehabilitation Exercise Program to Improve Cardiorespiratory Fitness in Women With Breast Cancer and Treatment Related Cardiotoxicity (CORE Study).|
|Estimated Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||December 1, 2018|
|Estimated Study Completion Date :||April 1, 2019|
Experimental: Exercise Rehabilitation
The intervention group will participate in the exercise rehabilitation program for a total of 12 weeks. This includes performing aerobic training five times per week and resistance training two to three times per week. Participants will also be expected to attend the education sessions following their supervised exercise rehabilitation sessions each week.
Other: Exercise Rehabilitation
The intervention will consist of a walking or biking program performed at an intensity of 60-80% of VO2peak, progressing to a minimum of 150 minutes/week. Each session will include a warm up and cool down. One weekly exercise session will be supervised and participants will be expected to complete four additional aerobic training sessions at home or in the community each week. Resistance training will be introduced during the 4th week of the program and will consist of 10 exercises targeting all major muscle groups. One weekly resistance training session will be supervised following the aerobic training, and participants will be expected to complete one to two additional sessions at home or in the community each week. Weekly education sessions will follow the supervised exercise session.
No Intervention: Usual Care
Participants in the control group will be encouraged to continue with their regular physical activity routine and will receive regular standard of care by their Cardiologist and Oncologist.
- Cardiopulmonary Fitness [ Time Frame: Baseline and 12 weeks ]A cardiopulmonary exercise test will be completed following the Bruce or modified Bruce protocol. Breath-by-breath gas samples will be collected and averaged over a 20-second period using a calibrated metabolic cart (Vmax Encore, SensorMedics, Yoba Linda, CA).
- Cardiovascular Risk Profile [ Time Frame: Baseline and 12 weeks ]This will be assessed using a standard blood requisition blood form including measurement of lipids, cholesterol, and triglyceride levels. Anthropometrics including body mass index, waist circumference, body fat percent and hemodynamic profiles including heart rate, systolic and diastolic blood pressure values (resting and during exercise) will also be collected.
- Cardiac Function and Structure at Rest [ Time Frame: Baseline and 12 weeks. ]2D Echocardiography will be used for the measurement of left ventricular volumes, cardiac output, stroke volume, left ventricular ejection fraction, diastolic function, left ventricular wall thickness and left ventricular cavity size. Strain and Strain Rate via 2D-Speckle tracking imaging will also be collected at rest to assess cardiac function.
- Cardiac Function During Stress (Exercise) [ Time Frame: Baseline and 12 weeks ]Exercise will be performed following a standardized stress echocardiography protocol. 2D-echocardiography assessments will be conducted at rest, during exercise and within 30 seconds of exercise completion.
- Endothelial Function [ Time Frame: Baseline and 12 weeks ]Endothelial dependant flow mediated dilation of the brachial artery will be assessed using a portable ultrasound unit (Vivid 9E GE Healthcare), and a 8-14-MHz transducer (GE Medical Systems Wauwatosa, WI USA).
- Arterial Stiffness [ Time Frame: Baseline and 12 weeks ]Arterial Stiffness will be measured by pulse-wave velocity (Sphygmocor® system).
- Autonomic Function [ Time Frame: Baseline and 12 weeks ]Baroreceptor sensitivity will be collected as a measure of autonomic function. Each participant will be secured with a three-lead ECG and finger plethysmography worn on the middle finger, while measures of a beat-by-beat blood pressure are recorded (Finapres; Ohmeda Inc, Englewood, CO).
- Quality of Life [ Time Frame: Baseline and 12 weeks ]
The Kansas City Cardiomyopathy Questionnaire will be used to assess health related quality of life for heart failure.
The FACT-B questionnaire will be used as a measurement of health related quality of life for individuals with breast cancer.
- Exercise Adherence [ Time Frame: Throughout the exercise training program (up to 12 weeks) ]Adherence will be assessed using an attendance sheet for each the supervised sessions. If participants do not complete their target exercise prescription, the reasons will be recorded. The participants will also complete weekly exercise diaries at home each week and will be asked to record reasons for missed sessions or if they were unable to meet their exercise prescription. A step counter (PiezoRx®) that monitors the participants' moderate/vigorous activity time (>100 steps per minute) as well as bouts per week (greater than 10 minutes of moderate/vigorous activity) will also be recorded. These measurements will be used to confirm the reported exercise sessions to be completed at home each week.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089502
|Contact: Alis J Bonsignore, MSc||416-597-3422 ext firstname.lastname@example.org|
|Contact: Paul Oh, MD,MScemail@example.com|
|Toronto Rehabilitation Institute||Recruiting|
|Toronto, Ontario, Canada|
|Contact: Alis Bonsignore, MSc firstname.lastname@example.org|
|Principal Investigator: Paul Oh|
|Principal Investigator:||Paul Oh, MD,MSc||University Health Network, Toronto|