Comparison of Aerobic and Resistance Exercise in Older Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Comparison of the effects of aerobic exercise vs flexibility and relaxation training (control) on fatigue, aerobic capacity, functioning, and health outcomes as measured at baseline and at 3, 6, 12, and 18 months
研究概览
简要总结
RATIONALE: Aerobic exercise, resistance exercise, and flexibility and relaxation training may reduce fatigue and improve the health and quality of life of breast cancer survivors. It is not yet known which type of exercise is more effective for inactive older female breast cancer survivors.
PURPOSE: This randomized clinical trial is studying aerobic exercise to see how well it works compared with resistance exercise or flexibility and relaxation training in improving the health and quality of life of inactive older female breast cancer survivors.
详细描述
OBJECTIVES:
Primary:
- Compare the effects of aerobic exercise vs flexibility and relaxation training (control) on fatigue, aerobic capacity, functioning, and health outcomes in inactive older female breast cancer survivors.
- Compare the effects of resistance exercise vs flexibility and relaxation training (control) on fatigue, muscle strength, functioning, and health outcomes.
Secondary:
- Compare the relative effects of aerobic exercise vs resistance exercise on fatigue, physical functioning, physical health, and mental health.
- Determine the mediating effects of fatigue and fitness on the relationship between exercise and physical functioning.
- Compare the individual and relative effects of aerobic exercise vs resistance exercise vs flexibility and relaxation training (control) on body composition and on biomarkers of cancer recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 120 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of breast cancer
- •Stage 0-III disease
- •Completed chemotherapy or radiotherapy > 2 years ago
- •Is not a regular participant in moderate aerobic exercise (i.e., jogging, swimming) or moderate resistance exercise (> 3 times/week for ≥ 30 minutes/session) OR in vigorous aerobic or resistance exercise (> 3 times/week for ≥ 20 minutes/session)
- •No stage IV breast cancer
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •Has obtained medical clearance to participate in study exercise programs
- •No cognitive difficulties that would preclude answering the survey questions, participating in the performance tests, or giving informed consent
- •No medical condition or movement or neurological disorder that would contraindicate participation in moderate intensity exercise training, as determined by physician clearance and the Principal Investigator
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No concurrent medication that would contraindicate participation in moderate intensity exercise training, as determined by physician clearance and the Principal Investigator
- •Concurrent hormonal therapy (e.g., selective estrogen receptor modulator (SERM) or aromatase inhibitor) for breast cancer allowed
排除标准
- 未提供
研究组 & 干预措施
progressive, aerobic exercise program
Patients undergo aerobic exercise training over approximately 45 minutes (not including warm-up or cool-down exercises) 3 days a week for 18 months.
干预措施: fatigue assessment and management (Procedure)
progressive, aerobic exercise program
Patients undergo aerobic exercise training over approximately 45 minutes (not including warm-up or cool-down exercises) 3 days a week for 18 months.
干预措施: exercise intervention (Behavioral)
progressive, aerobic exercise program
Patients undergo aerobic exercise training over approximately 45 minutes (not including warm-up or cool-down exercises) 3 days a week for 18 months.
干预措施: laboratory biomarker analysis (Other)
progressive, aerobic exercise program
Patients undergo aerobic exercise training over approximately 45 minutes (not including warm-up or cool-down exercises) 3 days a week for 18 months.
干预措施: questionnaire administration (Other)
progressive, aerobic exercise program
Patients undergo aerobic exercise training over approximately 45 minutes (not including warm-up or cool-down exercises) 3 days a week for 18 months.
干预措施: survey administration (Other)
progressive, aerobic exercise program
Patients undergo aerobic exercise training over approximately 45 minutes (not including warm-up or cool-down exercises) 3 days a week for 18 months.
干预措施: assessment of therapy complications (Procedure)
progressive, aerobic exercise program
Patients undergo aerobic exercise training over approximately 45 minutes (not including warm-up or cool-down exercises) 3 days a week for 18 months.
干预措施: management of therapy complications (Procedure)
progressive, aerobic exercise program
Patients undergo aerobic exercise training over approximately 45 minutes (not including warm-up or cool-down exercises) 3 days a week for 18 months.
干预措施: psychosocial assessment and care (Procedure)
progressive, resistance exercise program
Patients undergo resistance exercise training 3 days a week for 18 months.
干预措施: exercise intervention (Behavioral)
progressive, resistance exercise program
Patients undergo resistance exercise training 3 days a week for 18 months.
干预措施: laboratory biomarker analysis (Other)
progressive, resistance exercise program
Patients undergo resistance exercise training 3 days a week for 18 months.
干预措施: questionnaire administration (Other)
progressive, resistance exercise program
Patients undergo resistance exercise training 3 days a week for 18 months.
干预措施: survey administration (Other)
progressive, resistance exercise program
Patients undergo resistance exercise training 3 days a week for 18 months.
干预措施: assessment of therapy complications (Procedure)
progressive, resistance exercise program
Patients undergo resistance exercise training 3 days a week for 18 months.
干预措施: fatigue assessment and management (Procedure)
progressive, resistance exercise program
Patients undergo resistance exercise training 3 days a week for 18 months.
干预措施: management of therapy complications (Procedure)
progressive, resistance exercise program
Patients undergo resistance exercise training 3 days a week for 18 months.
干预措施: psychosocial assessment and care (Procedure)
flexibility and relaxation training [control]
Patients perform a series of whole body flexibility (stretching) and relaxation (guided imagery, progressive neuromuscular relaxation, focused breathing) exercises 3 days a week for 18 months.
干预措施: laboratory biomarker analysis (Other)
flexibility and relaxation training [control]
Patients perform a series of whole body flexibility (stretching) and relaxation (guided imagery, progressive neuromuscular relaxation, focused breathing) exercises 3 days a week for 18 months.
干预措施: questionnaire administration (Other)
flexibility and relaxation training [control]
Patients perform a series of whole body flexibility (stretching) and relaxation (guided imagery, progressive neuromuscular relaxation, focused breathing) exercises 3 days a week for 18 months.
干预措施: survey administration (Other)
flexibility and relaxation training [control]
Patients perform a series of whole body flexibility (stretching) and relaxation (guided imagery, progressive neuromuscular relaxation, focused breathing) exercises 3 days a week for 18 months.
干预措施: assessment of therapy complications (Procedure)
flexibility and relaxation training [control]
Patients perform a series of whole body flexibility (stretching) and relaxation (guided imagery, progressive neuromuscular relaxation, focused breathing) exercises 3 days a week for 18 months.
干预措施: fatigue assessment and management (Procedure)
flexibility and relaxation training [control]
Patients perform a series of whole body flexibility (stretching) and relaxation (guided imagery, progressive neuromuscular relaxation, focused breathing) exercises 3 days a week for 18 months.
干预措施: management of therapy complications (Procedure)
flexibility and relaxation training [control]
Patients perform a series of whole body flexibility (stretching) and relaxation (guided imagery, progressive neuromuscular relaxation, focused breathing) exercises 3 days a week for 18 months.
干预措施: psychosocial assessment and care (Procedure)
结局指标
主要结局
Comparison of the effects of aerobic exercise vs flexibility and relaxation training (control) on fatigue, aerobic capacity, functioning, and health outcomes as measured at baseline and at 3, 6, 12, and 18 months
时间窗: baseline,3 ,6 ,12, and 18 months
Comparison of the effects of resistance exercise vs flexibility and relaxation training (control) on fatigue, muscle strength, functioning, and health outcomes as measured at baseline and at 3, 6, 12, and 18 months
时间窗: baseline, 3 , 6 ,12, and 18 months
次要结局
- Comparison of the individual and relative effects of aerobic exercise vs resistance exercise vs flexibility and relaxation training (control) on body composition and on biomarkers of cancer recurrence as measured at baseline and at 3, 6, 12, and 18 ...(baseline, 3, 6, 12, and 18 months)
- Comparison of the relative effects of aerobic exercise vs resistance exercise on fatigue, physical functioning, physical health, and mental health as measured at baseline and at 3, 6, 12, and 18 months(baseline, 3, 6, 12, and 18 months)
- Determination of the mediating effects of fatigue and fitness on the relationship between exercise and physical functioning as measured at baseline and at 3, 6, 12, and 18 months(baseline, 3, 6, 12, and 18 months)