Weight Bearing Exercise in Preventing Frailty in Stage I-IIIA Breast Cancer Survivors
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About
This trial studies how well weight bearing exercise works in preventing frailty in stage I-IIIA breast cancer survivors. Weight bearing exercise, including muscle-strengthening, aerobic, flexibility, and balance exercises, can decrease fat and increase muscle, which may lead to reduced frailty.
Full description
PRIMARY OBJECTIVES:
I. Demonstrate reproducibility of forearm muscle activation and subcutaneous fat measures in a healthy convenience sample/population (N= 10).
II. Demonstrate that measures of muscle activation and signal attenuation by subcutaneous fat mass can be conducted in a systematic and reproducible fashion in breast cancer survivors prior to and following weight bearing exercise training.
III. In a cross sectional analysis, describe the level of lean muscle mass, muscle activation, strength, insulin resistance, inflammatory cytokines and growth factors, and inter-individual variability in breast cancer survivors prior to training.
IV. Describe the level of lean muscle mass, muscle activation, strength, insulin resistance, inflammatory cytokines (such as IL-6, CRP and others), and growth factors (such as myostatin, IGF-1, IGFBP-3 and others) in breast cancer survivors following weight bearing exercise training.
V. Evaluate the influence of genetic variability on response to prescribed training in breast cancer survivors.
OUTLINE:
Participants undergo a weight bearing exercise program in a group 2 days a week and at home 5 days a week for 8 weeks.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
- Post-menopausal (12 months without menstrual period: naturally, surgically, by hormone suppression).
- History of early stage breast cancer (stage I, II, IIIa).
- At least 6 months from chemotherapy.
- May be receiving hormonal therapy during the study.
- Currently disease-free, including a negative mammogram within 1 year.
- Body mass index (BMI) between 25 and 40kg/m^2.
- In general good health with no acute or chronic disease that could worsen with weight bearing exercise.
- Not currently on a prescribed diet nor reporting weight loss of > 10 pounds (lbs) in previous 3 months.
- Not currently participating in physical activity (PA) independently or a structured program (performing < 120 min of low-intensity, low-impact exercise per week; and no weightlifting or similar physical activity).
- Ability to participate in physical activity, not limited by severe disability (e.g., severe arthritic conditions); chronic back pain, or history or presence of diseases for which increased physical activity would not be advised.
- No severe chronic disease, other than breast cancer (e.g., human immunodeficiency virus/acquired immunodeficiency syndrome [HIV/AIDS], kidney failure, liver failure, chronic obstructive pulmonary disease, congestive heart failure, Alzheimer?s, unstable angina, uncontrolled asthma, uncontrolled diabetes, uncontrolled hypertension).
- No implanted cardiac pacemaker, cardiac defibrillator, or other implanted electronic medical equipment.
- No history of drug or alcohol abuse.
- Able to remain in a lying or sitting position for an extended period (> 30 minutes).
- No history or presence of a significant psychiatric disorder or any other condition that would interfere with participation in the trial.
- Medical clearance by treating physician.
- Willing to discontinue nonsteroidal antiinflammatory drug (NSAID) use, except Tylenol and baby aspirin (80mg), 1 week prior to blood draws.
- Willing to maintain body weight during the study.
- Can be reached by telephone.
- Willing to complete consent process and sign informed consent form.
Trial design
Primary purpose
Allocation
Interventional model
Masking
27 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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