Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 444
- 试验地点
- 1
- 主要终点
- Falls
研究概览
简要总结
This research is being done to compare the physical and quality of life benefits of two different types of exercise- tai chi versus strength training- for female cancer survivors who have had chemotherapy. Each exercise- tai chi and strength training- will be compared to participants in a group that performs flexibility and relaxation exercises, which is expected to have different benefits than either tai chi or strength training.
详细描述
PRIMARY OBJECTIVES:
I. Compare the relative efficacy of tai chi and strength training to prevent falls in female cancer survivors.
II. Determine the mechanism by which tai chi and strength training each reduces the risk of falls.
III. Determine how well the benefits of each intervention persist after structured training stops.
SECONDARY OBJECTIVE:
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with stage I-III cancer other than cancers of the brain or spinal cord (confirmed by patient self-report on the Health History Questionnaire; if patient is unable to confirm either the site of her cancer or that her stage of cancer is < stage IV, we will send a letter to her physician to confirm this criterion)
- •Completed chemotherapy > 3 months prior to enrollment and no concurrent adjuvant therapy other than hormone manipulation therapy for breast cancer (confirmed by patient self-report on the Health History Questionnaire; if patient is unable to confirm whether or not she completed chemotherapy 3 months prior to enrollment, we will send a letter to her physician to confirm eligibility on this criterion)
- •Postmenopausal (confirmed by self-report on the Health History Questionnaire; menopausal status could also be confirmed by a recent [< 6 months from enrollment] laboratory report documenting serum follicle-stimulating hormone [FSH] > 30 mIU/ml and/or serum estradiol < 30 pg/ml)
- •Currently underactive (< 60 minutes of moderate intensity exercise per week in the last month) (confirmed by self-report on the Health History Questionnaire)
排除标准
- •Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent (confirmed by the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone)
- •A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise (confirmed by self-report on the Health History Questionnaire, and by physician clearance; if in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible)
研究组 & 干预措施
Arm I (strength training)
Patients attend strength training classes for 1 hour 2 days per week.
干预措施: Exercise Intervention (Behavioral)
Arm I (strength training)
Patients attend strength training classes for 1 hour 2 days per week.
干预措施: Questionnaire Administration (Other)
Arm II (tai chi)
Patients attend tai chi classes for 1 hour 2 days per week.
干预措施: Exercise Intervention (Behavioral)
Arm II (tai chi)
Patients attend tai chi classes for 1 hour 2 days per week.
干预措施: Questionnaire Administration (Other)
Arm III (control)
Patients attend supervised stretching and relaxation classes for 1 hour 2 days per week.
干预措施: Exercise Intervention (Behavioral)
Arm III (control)
Patients attend supervised stretching and relaxation classes for 1 hour 2 days per week.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Falls
时间窗: Baseline up to 12 months
Prospective assessment of falls will be done by collecting monthly and quarterly reports returned by postal and/or electronic mail. A fall is defined as unintentionally coming to rest on the ground or at some other lower level, not as a result of a major intrinsic event (e.g., stroke or syncope) or overwhelming hazard.
次要结局
- Flexibility(Baseline, 3 and 6 months during study treatment and 6 months after completion of study)
- Injurious falls(Baseline up to 12 months)
- Postural stability(Baseline, 3 and 6 months during study treatment and 6 months after completion of study treatment)
- Physical Function(Baseline, 3 and 6 months during study treatment and 6 months after completion of study)
- Muscle strength(Baseline, 3 and 6 months during study treatment and 6 months after completion of study treatment)
研究者
Kerri Winters
Principal Investigator
OHSU Knight Cancer Institute