Cardio-Oncology Rehabilitation Exercise
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Toronto
About this trial
Women with breast cancer who are referred to the cardiac rehabilitation program at the Toronto Rehabilitation Institute will be invited to enrol in this observational study. Participants will take part in an established 16-week multimodal cardiac rehabilitation program (HEALTh program) at Toronto Rehabilitation Institute and outcome measures will be assessed before and after program participation to determine the effectiveness of the program in improving cardio metabolic health. Change in VO₂peak will be assessed using Cardiopulmonary Exercise Test (CPET). Traditional cardiac risk factors, lifestyle behaviours, exercise adherence, health-related quality of life, and fatigue will also be assessed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
History of early-stage breast cancer (I-III)
Currently receiving or have completed adjuvant therapy (i.e. chemotherapy, surgery, radiation, targeted therapies)
Able to communicate in English
Disqualifiers
Pregnancy
Metastatic disease (Stage IV)
Unable or unwilling to complete cardiopulmonary exercise test
Trial population
Female early-stage breast cancer survivors.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Cardiopulmonary Fitness
VO2peak assessed using cardiopulmonary exercise test
Time frame
post-intervention (16 weeks)Secondary outcomes
1
Visceral adipose tissue
Measured only in a subset (n=30) of participants via 1.5T MRI.
Time frame
post-intervention (16 weeks)2
Left ventricular ejection fraction
Measured only in a subset (n=30) of participants via 1.5T MRI.
Time frame
post-intervention (16 weeks)3
Native myocardial T1 time
Measured only in a subset (n=30) of participants via 1.5T MRI.
Time frame
post-intervention (16 weeks)4
Left ventricular mass
Measured only in a subset (n=30) of participants via 1.5T MRI.
Time frame
post-intervention (16 weeks)Other outcomes
1
Smoking Status
Smoking assessment history questionnaire
Time frame
post-intervention (16 weeks)2
Moderate-Intensity Physical Activity Time
PiezoRx® will be worn by participants for 7 days with data used to assess moderate activity time (\>100 steps per minute)
Time frame
averaged over 7 days post-intervention3
Vigorous-intensity Physical Activity
PiezoRx® will be worn by participants for 7 days with data used to assess vigorous activity time (\>120 steps per minute)
Time frame
averaged over 7 days post-intervention4
Physical Activity Bouts per Day
PiezoRx® will be worn by participants for 7 days with data used to assess bouts of physical activity per day (greater than 10 minutes of moderate/vigorous activity)
Time frame
averaged over 7 days post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Toronto
Lead sponsor
Toronto Rehabilitation Institute
Collaborator
Source ClinicalTrials.gov