Cardio-Oncology Rehabilitation Exercise

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT05522959
• Lead Sponsor: University of Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-14
• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-08-28
• Study First Posted: 2022-08-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-04
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary Fitness	post-intervention (16 weeks)	VO2peak assessed using cardiopulmonary exercise test

Secondary Outcome Measures

Name	Time	Method
Visceral adipose tissue	post-intervention (16 weeks)	Measured only in a subset (n=30) of participants via 1.5T MRI.
hemoglobin A1c	post-intervention (16 weeks)	Assessed via fasting blood draw
lipid profile	post-intervention (16 weeks)	Assessed via fasting blood draw
Left ventricular ejection fraction	post-intervention (16 weeks)	Measured only in a subset (n=30) of participants via 1.5T MRI.
Native myocardial T1 time	post-intervention (16 weeks)	Measured only in a subset (n=30) of participants via 1.5T MRI.
Fasting glucose	post-intervention (16 weeks)	Assessed via fasting blood draw
Psychosocial Stress	post-intervention (16 weeks)	Perceived Stress Scale (PSS). Minimum value = 0, maximum value = 56, where higher score represents more perceived stress.
Depressive symptoms	post-intervention (16 weeks)	Patient Health Questionnaire 9 scale. Minimum value = 0, maximum value = 27, where higher score represents more depressive symptoms.
Left ventricular mass	post-intervention (16 weeks)	Measured only in a subset (n=30) of participants via 1.5T MRI.
Cancer-related fatigue	post-intervention (16 weeks)	Fatigue sub-scale of the Functional Assessment of Cancer Therapy (FACT) questionnaire. Minimum score = 0, maximum score = 52, with higher score representing less fatigue.
Cancer-specific, health-related quality of life	post-intervention (16 weeks)	Functional Assessment of Cancer Therapy (FACT) questionnaire. Minimum score = 0, maximum score = 108, with higher score representing better quality of life.

Trial Locations

Locations (1)

Toronto Rehabilitation Institute; 🇨🇦 Toronto, Ontario, Canada