Cardio-Oncology Rehabilitation Exercise
CORE
A Single Arm Intervention Study to Assess the Role of Structured Cardio-Oncology Rehabilitation Exercise to Improve Cardiovascular Health in Early Stage Breast Cancer Survivors (CORE Study)
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2022
Longer than P75 for all trials
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
March 14, 2022
CompletedFirst Submitted
Initial submission to the registry
July 15, 2022
CompletedFirst Posted
Study publicly available on registry
August 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
October 1, 2025
September 1, 2025
4.7 years
July 15, 2022
September 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiopulmonary Fitness
VO2peak assessed using cardiopulmonary exercise test
post-intervention (16 weeks)
Secondary Outcomes (11)
Visceral adipose tissue
post-intervention (16 weeks)
Left ventricular ejection fraction
post-intervention (16 weeks)
Native myocardial T1 time
post-intervention (16 weeks)
Left ventricular mass
post-intervention (16 weeks)
lipid profile
post-intervention (16 weeks)
- +6 more secondary outcomes
Other Outcomes (7)
Smoking Status
post-intervention (16 weeks)
Moderate-Intensity Physical Activity Time
averaged over 7 days post-intervention
Vigorous-intensity Physical Activity
averaged over 7 days post-intervention
- +4 more other outcomes
Eligibility Criteria
Female early-stage breast cancer survivors.
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Metastatic disease (Stage IV)
- Unable or unwilling to complete cardiopulmonary exercise test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Torontolead
- Toronto Rehabilitation Institutecollaborator
Study Sites (1)
Toronto Rehabilitation Institute
Toronto, Ontario, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Kirkham, PhD
University of Toronto
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 15, 2022
First Posted
August 31, 2022
Study Start
March 14, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
October 1, 2025
Record last verified: 2025-09