Exercise for Breast Cancer Survivors

(BE-FITTER Trial)

Overseen By Stephen Foulkes, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Coronary artery disease, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it focuses on exercise programs for breast cancer survivors, so it's best to discuss your medications with the trial team.

What data supports the effectiveness of the treatment Group-based Yoga and Stretching, Yoga and Stretching Program, Group-based Exercise, Structured Exercise Training, Exercise Therapy, Physical Activity Intervention for breast cancer survivors?

Research shows that yoga and physical activity can improve the physical, mental, and social well-being of breast cancer survivors. Yoga, in particular, has been found to enhance quality of life, mood, and physical fitness, making it a beneficial complementary treatment for those recovering from breast cancer. ^{1 2 3 4 5}

Is exercise, like yoga and stretching, safe for breast cancer survivors?

Research shows that yoga and similar exercise programs are generally safe for breast cancer survivors, with studies focusing on improvements in physical fitness and quality of life without reporting significant safety concerns. ^{1 2 6 7 8}

How is the group-based yoga and stretching treatment unique for breast cancer survivors?

This treatment is unique because it combines yoga and stretching in a group setting, which not only improves physical fitness but also enhances psychological and social well-being. Unlike other treatments, it focuses on creating a supportive social environment and stimulating the mind and spirit, which can be particularly beneficial for breast cancer survivors. ^{1 2 3 4 9}

What is the purpose of this trial?

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 Criteria

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.

Inclusion Criteria

I am 60 years old or older.

I was diagnosed with early-stage breast cancer.

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

Exclusion Criteria

I have a long-term heart rhythm problem.

I have had a stroke in the past.

I have a history of heart failure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly enrolled in either a 12-week structured exercise training program or a 12-week stretching-yoga program to improve functional capacity, heart, and skeletal muscle function.

12 weeks

3 visits per week (in-person for exercise group), 1 visit per week (in-person for yoga group)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Group-based Yoga and Stretching
• Structured Exercise Training

Trial Overview 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.

Participant Groups

Group I: Experimental Arm: Structured Exercise Training Experimental Treatment 1 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 Stretching Active Control 1 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

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

Yoga has been shown to have short-term benefits on psychological health in breast cancer patients, significantly reducing anxiety, depression, and perceived stress, based on a systematic review of 12 randomized controlled trials involving 742 participants.

While yoga also appeared to improve health-related quality of life, these effects were less clear and potentially influenced by bias, indicating that yoga is particularly beneficial during active cancer treatment rather than after.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga for breast cancer patients and survivors: a systematic review and meta-analysis. Cramer, H., Lange, S., Klose, P., et al.[2022]

A six-month yoga-based exercise program for 20 breast cancer survivors led to significant improvements in physical fitness, including a 3% reduction in body fat and increased leg strength and flexibility.

Participants in the yoga group outperformed those in a comparison group on measures of forward reach, demonstrating that yoga can be a safe and effective exercise option for enhancing fitness in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a six-month yoga exercise intervention on fitness outcomes for breast cancer survivors. Hughes, DC., Darby, N., Gonzalez, K., et al.[2018]

Physical activity interventions are generally effective in improving the physical, mental, and social well-being of breast cancer survivors, based on a review of systematic reviews and meta-analyses.

Among various physical activities, yoga has been identified as the most effective complementary intervention to enhance the overall quality of life for breast cancer survivors, although the studies reviewed showed significant variability in their methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Practice of Physical Activity on Psychological, Mental, Physical, and Social Wellbeing for Breast-Cancer Survivors: An Umbrella Review. Zanghì, M., Petrigna, L., Maugeri, G., et al.[2022]

Exercise significantly benefits breast cancer survivors, with recommendations for moderate-intensity aerobic activity 3 to 5 days a week for 20 to 60 minutes, along with resistance training.

Psychological health improves with enjoyable exercise that includes social interaction and skill development, while modifications may be needed for conditions like fatigue or lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for breast cancer survivors: research evidence and clinical guidelines. Courneya, KS., Mackey, JR., McKenzie, DC.[2010]

A review of 71 studies indicates that yoga can improve quality of life (QOL) for women undergoing breast cancer treatment, enhancing aspects like physical well-being, emotional health, and social functioning.

Despite the positive findings, the review highlights the need for more rigorous research to pinpoint which specific elements of yoga are most beneficial for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga and quality-of-life improvement in patients with breast cancer: a literature review. Levine, AS., Balk, JL.[2012]

Women with breast cancer undergoing chemotherapy who participated in a Tibetan yoga program (TYP) reported fewer daily sleep disturbances shortly after treatment compared to those in a stretching program (STP) and usual care (UC).

Long-term benefits in sleep quality were observed for TYP participants who practiced regularly (at least 2 times a week), showing improved sleep outcomes at 3 and 6 months after treatment compared to those who did not practice and those in the UC group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of Tibetan yoga in patients with breast cancer undergoing chemotherapy. Chaoul, A., Milbury, K., Spelman, A., et al.[2019]

A systematic review of 16 randomized controlled trials involving 930 breast cancer patients found that yoga significantly improved health-related quality of life, depression, anxiety, and gastrointestinal symptoms compared to control groups.

The benefits of yoga were more pronounced when practiced for over 3 months, particularly in reducing anxiety, suggesting that longer durations of practice may enhance its effectiveness as a complementary therapy for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Could yoga practice improve treatment-related side effects and quality of life for women with breast cancer? A systematic review and meta-analysis. Pan, Y., Yang, K., Wang, Y., et al.[2018]

After educational interventions, interest in yoga among older veterans who are cancer survivors significantly increased from 5.5% to 31.8%, indicating that knowledge can enhance engagement with yoga as a therapeutic option.

Participation in a yoga program led to improved beliefs about its benefits and physical function, particularly for those who initially had higher expectations about yoga, suggesting that targeted interventions can effectively address barriers to access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Access to Yoga for Older Male Veterans After Cancer: Examining Beliefs About Yoga. Auguste, EJ., Weiskittle, RE., Sohl, SJ., et al.[2022]

The study involved 63 breast cancer survivors across 66 group exercise counseling sessions, revealing that while a breast cancer diagnosis creates a common bond, factors like age and expectations can hinder group cohesion.

Key barriers to adherence included feelings of risk for cancer recurrence and people-pleasing behavior, highlighting the need for mental health referrals and effective behavioral modification techniques in group settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned in the trenches: facilitating exercise adherence among breast cancer survivors in a group setting. Rogers, LQ., Vicari, S., Courneya, KS.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Yoga for breast cancer patients and survivors: a systematic review and meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effect of a six-month yoga exercise intervention on fitness outcomes for breast cancer survivors. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Practice of Physical Activity on Psychological, Mental, Physical, and Social Wellbeing for Breast-Cancer Survivors: An Umbrella Review. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Exercise for breast cancer survivors: research evidence and clinical guidelines. [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Yoga and quality-of-life improvement in patients with breast cancer: a literature review. [2012]

6. United States pubmed.ncbi.nlm.nih.gov

Randomized trial of Tibetan yoga in patients with breast cancer undergoing chemotherapy. [2019]

7. Australia pubmed.ncbi.nlm.nih.gov

Could yoga practice improve treatment-related side effects and quality of life for women with breast cancer? A systematic review and meta-analysis. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Enhancing Access to Yoga for Older Male Veterans After Cancer: Examining Beliefs About Yoga. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Lessons learned in the trenches: facilitating exercise adherence among breast cancer survivors in a group setting. [2021]