Exercise for Breast Cancer Survivors (BE-FITTER Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alberta
No Placebo Group
Trial Summary
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.
What data supports the idea that Exercise for Breast Cancer Survivors is an effective treatment?The available research shows that exercise, including yoga, is beneficial for breast cancer survivors. A six-month yoga program led to improvements in physical fitness, such as reduced body fat. Yoga also helps improve quality of life and psychological health. An umbrella review found that physical activity, especially yoga, enhances physical, mental, and social well-being. Compared to other activities, yoga is highlighted as the most effective complementary treatment for improving life quality in breast cancer survivors.13469
Do I have to stop my current medications for this trial?The protocol does not specify whether you need to stop taking your current medications. However, since the trial focuses on exercise programs, it might not require changes to your medication regimen. Please consult with the trial coordinators for specific guidance.
Is Group-based Yoga and Stretching a promising treatment for breast cancer survivors?Yes, Group-based Yoga and Stretching is a promising treatment for breast cancer survivors. It can improve physical fitness, reduce body fat, and enhance overall well-being, including physical, mental, and social aspects. Yoga, in particular, is highlighted as an effective way to complement medical therapy and improve quality of life.12369
What safety data exists for exercise treatments in breast cancer survivors?The research indicates that yoga and exercise programs are generally safe and beneficial for breast cancer survivors. Studies have shown improvements in physical fitness, quality of life, and psychological health. No specific safety concerns were highlighted in the studies, suggesting these interventions are well-tolerated.35678
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.
I have a history of COPD.
I showed signs of heart strain during a stress test.
I have a history of heart artery disease.
Participant Groups
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.
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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of AlbertaEdmonton, Canada
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Who is running the clinical trial?
University of AlbertaLead Sponsor
Canadian Institutes of Health Research (CIHR)Collaborator
References
Exercise for breast cancer survivors: research evidence and clinical guidelines. [2010]Exercise can have significant benefits for breast cancer survivors during and after treatment. The general aerobic prescription is for moderate-intensity activity (50% to 75% heart rate reserve), 3 to 5 days per week, 20 to 60 minutes per session. Resistance training should also be incorporated into the programs. Psychological health is optimized by exercise that is enjoyable, develops new skills, incorporates social interaction, and takes place in a mind- and spirit-stimulating environment. Conditions that warrant prescription modification include fatigue and nausea, cytopenias, lymphedema, and bone metastasis. Postcancer exercise is facilitated by instilling a positive attitude toward exercise, confidence in overcoming barriers, and a supportive social environment.
Lessons learned in the trenches: facilitating exercise adherence among breast cancer survivors in a group setting. [2021]Improving effectiveness of group exercise counseling for breast cancer survivors is needed.
Yoga for breast cancer patients and survivors: a systematic review and meta-analysis. [2022]Many breast cancer patients and survivors use yoga to cope with their disease. The aim of this review was to systematically assess and meta-analyze the evidence for effects of yoga on health-related quality of life and psychological health in breast cancer patients and survivors.
Yoga and quality-of-life improvement in patients with breast cancer: a literature review. [2012]Women undergoing treatment for breast cancer often turn to complementary and alternative medicine (CAM), including yoga, for improvement of mood, quality of life (QOL), sleep, and treatment-related side effects. The extant literature was reviewed to examine the clinical effects of yoga practice on QOL for patients with breast cancer. QOL was defined as physical well-being, social functioning, emotional health, and function-al adaptation.
Could yoga practice improve treatment-related side effects and quality of life for women with breast cancer? A systematic review and meta-analysis. [2018]To determine if yoga as a complementary and alternative therapy was associated with enhanced health and treatment-related side effects in patients with breast cancer. This systematic review examines whether yoga practice provides any measurable benefit, both physically and psychologically, for women with breast cancer.
Effect of a six-month yoga exercise intervention on fitness outcomes for breast cancer survivors. [2018]Yoga-based exercise has proven to be beneficial for practitioners, including cancer survivors. This study reports on the improvements in physical fitness for 20 breast cancer survivors who participated in a six-month yoga-based exercise program (YE). Results are compared to a comprehensive exercise (CE) program group and a comparison (C) exercise group who chose their own exercises. "Pre" and "post" fitness assessments included measures of anthropometrics, cardiorespiratory capacity, strength and flexibility. Descriptive statistics, effect size (d), dependent sample 't' tests for all outcome measures were calculated for the YE group. Significant improvements included: decreased % body fat (-3.00%, d = -0.44, p
Randomized trial of Tibetan yoga in patients with breast cancer undergoing chemotherapy. [2019]The current randomized trial examined the effects of a Tibetan yoga program (TYP) versus a stretching program (STP) and usual care (UC) on sleep and fatigue in women with breast cancer who were undergoing chemotherapy.
Enhancing Access to Yoga for Older Male Veterans After Cancer: Examining Beliefs About Yoga. [2022]Yoga is an effective clinical intervention for cancer survivors. Most studies of the positive effects of yoga on cancer patients report on predominantly middle-aged women with breast cancer. Less is known about the use of yoga in older adults, veterans, and those from diverse racial or ethnic backgrounds.
The Practice of Physical Activity on Psychological, Mental, Physical, and Social Wellbeing for Breast-Cancer Survivors: An Umbrella Review. [2022](1) Background: The number of breast-cancer patients and survivors is increasing in the last years. Physical activity seems to be a feasible and useful complementary intervention to improve the physical, psychological, and social spheres and decrease some symptoms, especially for survivors. Consequently, the objective of the present umbrella review was to analyze the efficacy of different physical-activity interventions in the physical, mental, and social spheres of breast-cancer survivors. (2) Methods: Systematic reviews and meta-analyses of randomized controlled trials on breast-cancer survivors and physical-activity effects were searched on the electronic databases PubMed, Web of Science, and Scopus till 9 August 2022. The quality of the studies included was evaluated, and the results were narratively analyzed. (3) Results: Physical-activity intervention generally improves the physical, mental, and social spheres of breast-cancer survivors, but the studies included present heterogeneity in the protocols adopted. (4) Conclusions: A well-structured and planned physical-activity intervention is useful for improvements in the physical, mental, and social spheres of breast-cancer survivors, but the studies presented high heterogeneity. Yoga seems to be the most effective physical intervention to complement medical therapy.