Group Exercise Training for Fall Prevention and Functional Improvements During and After Treatment for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Number of Falls
研究概览
简要总结
The GET FIT Prostate trial (Group Exercise Training for Fall prevention and functional Improvements during and after Treatment for Prostate cancer) is a single-blind, parallel group, randomized controlled trial comparing - 1) tai ji quan (functional balance) and 2) strength training (functional strength) against each other and vs. 3) a stretching control (functional mobility) - over a 6-mos. supervised intervention and 6-mos. follow-up. Two million prostate cancer survivors are alive in the U.S. and nearly half (45%) will receive androgen deprivation therapy (ADT) to reduce tumor androgen exposure and slow down cancer progression. While beneficial for cancer survival, significant treatment-induced side effects from ADT may lead to serious health consequences including falls, frailty, and dysfunction that contribute to morbidity and mortality
详细描述
PRIMARY OBJECTIVE:
I. To determine and compare the efficacy of tai ji quan training and strength training in reducing the incidence of falls in prostate cancer survivors on antiandrogen therapy (ADT).
SECONDARY OBJECTIVE:
I. To determine and compare the efficacy of tai ji quan training and strength training to reduce frailty and dysfunction in prostate cancer survivors on ADT.
TERTIARY 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)
盲法说明
Outcomes assessors will be masked to the participants assigned study arm. Participants will not be formally masked from knowing whether or not they are assigned to an experimental or control group, but every effort will be made not to overemphasize expected outcomes.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with histologically confirmed prostate cancer (confirmed by self-report on Health History Questionnaire. In the case a participant isn't able to confirm this criterion, a letter will be sent to his physician.)
- •Currently on ADT for >= 6 months OR not currently receiving ADT, but received >= 6-month course within the last 10 years (confirmed by self-report on Health History Questionnaire. In the case a participant isn't able to confirm this criterion, a letter will be sent to his physician.)
- •If they have had other treatment, such as surgery, radiation or chemotherapy, it must have been completed >= 6 weeks prior to enrollment and no concurrent adjuvant therapy other than ADT for prostate cancer (confirmed by self-report on Health History Questionnaire. In the case a participant isn't able to confirm this criterion, a letter will be sent to his physician).
- •Meets criteria for having experienced >= 1 fall in the last year (confirmed by self-report on Health History Questionnaire) or if no falls, meets criteria for slow Timed Up and Go (TUG) time (>= 12.0 seconds) OR slow chair stand time (>= 10.0 seconds) (confirmed by baseline screening testing).
排除标准
- •Current participation in moderate or vigorous lower-body strength training two or more times per week for 30 minutes or more or participating in tai chi two or more times per week for 30 minutes or more (confirmed by self-report on Health History Questionnaire or by discretion of the principal investigator).
- •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/or 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.).
- •Not medically cleared for participation in moderate intensity exercise. (Confirmed by physician clearance.).
- •Knowingly unable to attend > 75% of the intervention classes due to conflict with the designated time of day, days of the week, and/or location for the exercise class which they initially enrolled. (Confirmed by documentation in the Case Report Form titled "CRF - Participant Contact Info_GET FIT Prostate").
- •Not fluent in English and therefore incapable of answering survey questions, participating in class, following directions during performance testing, and providing informed consent when English is the language used. (Confirmed by documentation in the Case Report Form titled "CRF - Participant Contact Info_GET FIT Prostate" or the professional opinion of the principal investigator, Dr. Kerri Winters-Stone.).
研究组 & 干预措施
Strength Training
Participants wear a weighted vest while performing exercises using functional movement patterns used in everyday activities (chair rises, 90° squats, side-to-side squats, toe raises, lunges (forward, lateral, backward, walking), multi-directional step ups). Participants attend supervised, group-based moderate-intensity strength training program remotely 3 times per week for 60 minutes per session.
干预措施: Resistance Training (Other)
Stretching Control
Participants attend a supervised flexibility program where they will perform a series of whole body stretching exercises with a focus on developing and maintaining a healthy back. Participants attend a supervised, group-based supervised flexibility program remotely 3 times per week for 60 minutes per session.
干预措施: Stretching (Other)
Tai Ji Quan Training
An integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements. Participants attend a supervised, group-based tai ji quan program remotely where they perform an integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements 3 times per week for 60 minutes per session.
干预措施: Tai Chi (Other)
结局指标
主要结局
Number of Falls
时间窗: Baseline up to 6 months
Prospective assessment of falls will be done by collecting monthly 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
- Fatigue-general(Baseline up to 12 months)
- Fatigue-cancer(Baseline up to 12 months)
- Flexibility(Baseline up to 12 months)
- Lean Body Mass(Baseline up to 12 months)
- Change in Functional Mobility(Baseline up to 12 months)
- Muscle Strength(Baseline up to 12 months)
- Fatigue-cancer(Baseline up to 12 months)
- Flexibility(Baseline up to 12 months)
- Physical Activity(Baseline up to 12 months)
- Change in Perceived Physical Function(Baseline up to 12 months)
- Change in Total Frailty Score(Baseline up to 12 months)
- Fatigue-general(Baseline up to 12 months)
- Walk Speed(Baseline up to 12 months)
- Change in Functional Balance(Baseline up to 12 months)
研究者
Kerri Winters
Principal Investigator
OHSU Knight Cancer Institute