Clinical trial NCT05522959: Cardio-Oncology Rehabilitation Exercise
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: Cardiac Rehabilitation
Cardio-oncology
Cardiometabolic Health
Cardiovascular Disease Risk
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Toronto Rehabilitation Institute
First posted: 2022-08-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female early-stage breast cancer survivors.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Pregnancy
* Metastatic disease (Stage IV)
* Unable or unwilling to complete cardiopulmonary exercise test

Primary outcomes:
measure: Cardiopulmonary Fitness
timeFrame: post-intervention (16 weeks)
Secondary outcomes:
measure: Visceral adipose tissue
timeFrame: post-intervention (16 weeks)
measure: Left ventricular ejection fraction
timeFrame: post-intervention (16 weeks)
measure: Native myocardial T1 time
timeFrame: post-intervention (16 weeks)
measure: Left ventricular mass
timeFrame: post-intervention (16 weeks)
measure: lipid profile
timeFrame: post-intervention (16 weeks)
measure: Fasting glucose
timeFrame: post-intervention (16 weeks)
measure: hemoglobin A1c
timeFrame: post-intervention (16 weeks)
measure: Cancer-specific, health-related quality of life
timeFrame: post-intervention (16 weeks)
measure: Depressive symptoms
timeFrame: post-intervention (16 weeks)
measure: Psychosocial Stress
timeFrame: post-intervention (16 weeks)
measure: Cancer-related fatigue
timeFrame: post-intervention (16 weeks)
Other outcomes:
measure: Smoking Status
timeFrame: post-intervention (16 weeks)
measure: Moderate-Intensity Physical Activity Time
timeFrame: averaged over 7 days post-intervention
measure: Vigorous-intensity Physical Activity
timeFrame: averaged over 7 days post-intervention
measure: Physical Activity Bouts per Day
timeFrame: averaged over 7 days post-intervention
measure: Total daily steps
timeFrame: averaged over 7 days post-intervention
measure: Self-Reported Physical Activity
timeFrame: post-intervention (16 weeks)
measure: Diet quality
timeFrame: post-intervention (16 weeks)
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
Study officials:
affiliation: University of Toronto
name: Amy Kirkham, PhD
role: PRINCIPAL_INVESTIGATOR
References: