Recruiting

Exercise Training & Stretching-Yoga

Sponsor:

University of Alberta

Code:

NCT06595147

Conditions

Breast Cancer

Disability Physical

Heart Failure

Cardiotoxicity

Eligibility Criteria

Sex: Female

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Structured Exercise Training

Group-based Yoga and Stretching

Study Details

Brief summary:

The chemotherapy medications used for breast cancer treatment are important for achieving a cure, but a potential side effect is that they can cause a decline in functional capacity (reduced exercise tolerance and impaired physical function) and increase the risk of cardiovascular disease. The risks of decreased functional capacity and cardiovascular disease are highest in breast cancer survivors as they grow older. The factors causing the decline in functional capacity are not well understood, however they may be related to a reduction in cardiac function (e.g. decreased pumping ability of the heart) or skeletal muscle function (reduced muscle blood flow and oxygenation). Exercise training is used for other populations at risk for cardiovascular disease (such as cardiac rehabilitation), but is not routinely offered to breast cancer survivors. Therefore this research study wants to test whether exercise training can improve heart and muscle health, and increase functional capacity in up to 60 older breast cancer survivors aged >60 years old who previously received chemotherapy drugs that can affect the heart.

The purpose of this study is to compare two rehabilitation approaches: a 12-week structured exercise training program or a 12-week stretching-yoga program. The investigators want to compare whether these programs can improve functional capacity, and heart and skeletal muscle function. To do this, some of the participants in this study will be randomly enrolled in the structured exercise training program and others will be randomly enrolled in the stretching-yoga program.

Conditions

Breast Cancer

Disability Physical

Heart Failure

Cardiotoxicity

Study ID

NCT06595147

Start date

Jul 1, 2024

Status verified date

Jan, 2026

Completion date

Dec 20, 2026

Anticipated

Primary completion date

Dec 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥60 years
  • Previously diagnosed with early-stage (I-III) BC
  • Completed (≥1 year post) primary cardiotoxic treatment (anthracycline-based chemotherapy or trastuzumab-based biological therapy).

Exclusion Criteria:

  • Have a history of coronary artery disease, heart failure, persistent and permanent arrhythmia (e.g. currently in atrial fibrillation), stroke, or chronic obstructive pulmonary disease
  • Develop signs or symptoms of myocardial ischemia (≥1mm horizontal or down-sloping ST segment depression on electrocardiogram) during the cardiopulmonary (VO2peak) test
  • Have any research MRI contraindications (e.g. any type of pacemaker), or any orthopedic limitation preventing exercise testing
  • Currently performing structured exercise training (defined as ≥30 mins/day of moderate-to-vigorous aerobic and/or resistance exercise training on ≥4 days/week)
  • Are unwilling to be randomized to either ExT or STRETCH

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Experimental Arm: Structured Exercise Training

Participants randomized to exercise training will be provided with a 12-week structured exercise training program. The program includes 3 weekly sessions of aerobic exercise (e.g treadmill, cycling, elliptical machine) and/or resistance training (i.e lifting weights). The aerobic sessions will include long-endurance (40-60 minutes at moderate intensity), tempo (30-40 minutes at a moderate-vigorous intensity) and high-intensity interval exercise (10-15 intervals of 30-60 seconds at 100% peak aerobic power output, interspersed with 60 seconds of active recovery). Resistance training will include 4-6 lower body exercises performed for 2-3 sets of 8-20 repetitions at a load equivalent to 60-85% of their one repetition maximum. The program will be supervised by an exercise trainer (Clinical Exercise Physiologist, Physiotherapist, Kinesiologist or Research Associate with exercise training experience) and will be individualized each individual's baseline fitness and medical history.

active comparator: Active Comparator: Group-based Yoga and Stretching

Participants allocated to the yoga and stretching group will provided with a once weekly yoga and stretching group class. The classes will consist of a combination of light-intensity yoga, balance and stretching exercises. The yoga and stretching class will be overseen by a yoga instructor, physiotherapist, physiotherapy trainee or research assistant with exercise training background

Interventions

Structured Exercise Training

Participants will complete 12-weeks of supervised, structured moderate-to-high intensity aerobic and resistance training three times per week.

Group-based Yoga and Stretching

Participants will complete 12-weeks of supervised group-based yoga and stretching once per week.

Primary outcome measure

  • Peak arterio-venous oxygen content difference [ Time Frame: 12 Weeks ]
  • Peak cardiac output [ Time Frame: 12 Weeks ]

Central Contacts and Locations

Central contacts

Nathan Weeldreyer, PhD

616.566.6756ageheart@ualberta.ca

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G1C9

Contacts

Nathan Weeldreyer, PhD

616.566.6756ageheart@ualberta.ca

Principal Investigator:

Mark Haykowsky, PhD

More Information

Sponsor

University of Alberta

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Keywords

  • Exercise Training
  • Fitness
  • Heart
  • Muscle
  • Cancer
  • Survivorship

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-01-08.