← Back to Search

Behavioral Intervention

Exercise for Breast Cancer Survivors (BE-FITTER Trial)

N/A

Recruiting

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥60 years

Previously diagnosed with early-stage (I-III) BC

Must not have

History of persistent and permanent arrhythmia (e.g. currently in atrial fibrillation)

History of stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effects of exercise training on heart and muscle health, as well as functional capacity in older breast cancer survivors who have undergone chemotherapy. The study will compare a 12-week structured

Who is the study for?

This trial is for older breast cancer survivors over 60 who've had chemotherapy that might affect the heart. They should be interested in improving their heart and muscle health, and increasing physical function. Participants must not have conditions that would limit safe engagement in exercise or yoga.

What is being tested?

The BE-FITTER Study compares a structured exercise training program with a group-based stretching-yoga program to see which is better at improving functional capacity, as well as heart and skeletal muscle function in older breast cancer survivors.

What are the potential side effects?

Potential side effects from participating may include typical risks associated with physical activity such as muscle soreness, fatigue, or injury. The study aims to monitor participants closely to minimize these risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 60 years old or older.

Select...

I was diagnosed with early-stage breast cancer.

Select...

It's been over a year since I finished treatment with heart-risky cancer drugs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a long-term heart rhythm problem.

Select...

I have had a stroke in the past.

Select...

I have a history of heart failure.

Select...

I have a history of COPD.

Select...

I showed signs of heart strain during a stress test.

Select...

I have a history of heart artery disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Peak arterio-venous oxygen content difference

Peak cardiac output

Secondary study objectives

10-year Framingham Risk Score

Aerobic endurance

Calf muscle aerobic capacity

+10 more

Other study objectives

C-reactive protein

Fasting Glycaemic Control

Fasting Insulin Resistance

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Arm: Structured Exercise TrainingExperimental Treatment1 Intervention

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.

Group II: Active Comparator: Group-based Yoga and StretchingActive Control1 Intervention

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

0 / 9Eligibility criteria met