Breast cancEr, FITness and ExeRcise for Heart Health: The BE-FITTER Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 60
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Canada
University of Alberta
RECRUITING
Edmonton
Contact Information
Primary
Stephen Foulkes, PhD
ageheart@ualberta.ca
+1-780-668-1669
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2025-12-20
Participants
Target number of participants: 60
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: University of Alberta

This content was sourced from clinicaltrials.gov