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NCT Number: NCT05522959

Cardio-Oncology Rehabilitation Exercise

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Toronto Rehabilitation Institute

Toronto, Ontario, Canada

Location status: Recruiting

Location contact

Paul Oh, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cardiopulmonary Fitness

    Time frame: post-intervention (16 weeks)

    VO2peak assessed using cardiopulmonary exercise test

Secondary outcomes

  1. Visceral adipose tissue

    Time frame: post-intervention (16 weeks)

    Measured only in a subset (n=30) of participants via 1.5T MRI.

  2. Left ventricular ejection fraction

    Time frame: post-intervention (16 weeks)

    Measured only in a subset (n=30) of participants via 1.5T MRI.

  3. Native myocardial T1 time

    Time frame: post-intervention (16 weeks)

    Measured only in a subset (n=30) of participants via 1.5T MRI.

  4. Left ventricular mass

    Time frame: post-intervention (16 weeks)

    Measured only in a subset (n=30) of participants via 1.5T MRI.

  5. lipid profile

    Time frame: post-intervention (16 weeks)

    Assessed via fasting blood draw

  6. Fasting glucose

    Time frame: post-intervention (16 weeks)

    Assessed via fasting blood draw

  7. hemoglobin A1c

    Time frame: post-intervention (16 weeks)

    Assessed via fasting blood draw

  8. Cancer-specific, health-related quality of life

    Time frame: 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.

  9. Depressive symptoms

    Time frame: post-intervention (16 weeks)

    Patient Health Questionnaire 9 scale. Minimum value = 0, maximum value = 27, where higher score represents more depressive symptoms.

  10. Psychosocial Stress

    Time frame: post-intervention (16 weeks)

    Perceived Stress Scale (PSS). Minimum value = 0, maximum value = 56, where higher score represents more perceived stress.

  11. Cancer-related fatigue

    Time frame: 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.

Other outcomes

  1. Smoking Status

    Time frame: post-intervention (16 weeks)

    Smoking assessment history questionnaire

  2. Moderate-Intensity Physical Activity Time

    Time frame: averaged over 7 days post-intervention

    PiezoRx® will be worn by participants for 7 days with data used to assess moderate activity time (>100 steps per minute)

  3. Vigorous-intensity Physical Activity

    Time frame: averaged over 7 days post-intervention

    PiezoRx® will be worn by participants for 7 days with data used to assess vigorous activity time (>120 steps per minute)

  4. Physical Activity Bouts per Day

    Time frame: averaged over 7 days post-intervention

    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)

  5. Total daily steps

    Time frame: averaged over 7 days post-intervention

    PiezoRx® will be worn by participants for 7 days with data used to assess total daily steps

  6. Self-Reported Physical Activity

    Time frame: post-intervention (16 weeks)

    Godin Leisure Time Physical Activity Questionnaire

  7. Diet quality

    Time frame: post-intervention (16 weeks)

    Rapid Eating and Activity Assessment for Participants (REAP) questionnaire. Minimum score = 13, maximum score = 39, with a higher score indicating a higher diet quality.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy A Kirkham, PhD

CONTACT

[email protected]

(416) 946-4069‬‬

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Toronto Rehabilitation Institute

Registry information

Official study 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)

Acronym: CORE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2022
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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