RecruitingNAINTERVENTIONAL

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

The BE-FITTER study is for women over 60 who've received chemotherapy for breast cancer. While chemotherapy is vital, it can sometimes affect the heart and make daily activities harder. We want to see if structured exercise or a stretching-yoga program can help improve heart and muscle health, and make people feel fitter. Participants will be randomly assigned to either a 12-week exercise program or a 12-week stretching and yoga program. The aim is to compare which approach is more effective at improving overall fitness and how well the heart and muscles work.

At a glance

Status

Recruiting

Phase

Sponsor

University of Alberta

Enrolment target

Start

01 Jul 2024

Estimated completion

20 Dec 2026

Breast Cancer Disability Physical Heart Failure Cardiotoxicity

What is this study about?

Chemotherapy is a very important treatment for breast cancer, helping many people get better. However, some chemotherapy drugs, while effective against cancer, can sometimes affect your heart over time and make it harder to do daily activities like walking or climbing stairs. This can be more noticeable as you get older.

Doctors don't fully understand why some people experience these effects, but it might be related to how well your heart pumps or how your muscles work. We know that exercise can be very good for heart health in other situations, but it's not often suggested as a routine part of recovery for breast cancer survivors. This study wants to find out if specific exercise programs can make a difference.

We are looking to compare two different approaches: a structured exercise program or a stretching and yoga program. The study will last 12 weeks, and we will carefully check if these programs can help improve your heart and muscle health, and ultimately make you feel fitter and more able to do your usual activities.

Key takeaways

This study is for women aged 60 and over who have completed breast cancer chemotherapy.
It compares a structured exercise program with a stretching-yoga program.
The goal is to improve heart health, muscle function, and overall fitness.
The study lasts 12 weeks, with health checks before and after.
Participation involves being randomly assigned to one of two activity groups.

Who may be eligible?

This study is looking for women who are 60 years old or older. You should have been diagnosed with early-stage breast cancer (Stage I, II, or III) in the past.

It's also important that you finished your main breast cancer treatment, including any chemotherapy that might affect the heart (like anthracycline-based chemo or trastuzumab-based therapy), at least one year ago.

There are also some reasons why you might not be able to join. For example, if you have a history of certain heart problems, lung disease, or conditions that prevent you from doing exercise or having an MRI scan. Also, if you are already doing a lot of structured exercise (like working out 4 or more days a week for at least 30 minutes), or if you wouldn't be comfortable with being randomly put into either the exercise or the stretching/yoga group, then this study might not be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 60 or older?
Did you have early-stage breast cancer (Stage I-III)?
Did you finish your main chemotherapy (like anthracycline-based or trastuzumab-based) at least one year ago?
Do you *not* have a history of serious heart problems, lung disease, or conditions that stop you from exercising or having an MRI scan?
Are you comfortable with being randomly placed into either an exercise or a yoga/stretching group?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to either a 12-week structured exercise program or a 12-week stretching and yoga program. This means a computer decides which group you are in, like flipping a coin for fairness. Both programs involve regular sessions.

Throughout the study, you will have various health checks and tests. These may include tests to see how well your heart and muscles are working, and how fit you are. Some checks might involve a special type of scan called an MRI to look at your heart and muscles in detail. These assessments will happen at the beginning and end of the 12-week program.

There will be no new medications given as part of this study. The total duration of your active involvement will be around 12 weeks, with some assessments before and after.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as improving your heart health, muscle strength, and general fitness, which could make everyday tasks feel easier. There are always some potential risks with exercise, such as muscle soreness or minor injury, but the programs are designed to be safe and supervised. You’ll have tests like MRI scans, which carry their own small risks, but trained staff will ensure your safety. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University of Alberta
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What kind of exercise will I do?

You will either be in a group doing structured exercise training or a group doing yoga and stretching. The study will randomly assign you to one of these.

How long will the study last?

The exercise or yoga program itself lasts for 12 weeks. You'll have health checks before and after this period.

Will I have to take any new medicines?

No, this study does not involve any new medications. It focuses on physical activities.

Why is this study important?

This study hopes to find the best ways to help women who've had breast cancer chemotherapy stay healthy and active, especially protecting their heart health as they get older.

Can I choose which group to be in?

No, participants are randomly put into either the exercise or the stretching/yoga group, just like drawing lots, to make the comparison fair.

How to find out more

Nathan Weeldreyer, PhD

ageheart@ualberta.ca 616.566.6756 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.