Feasibility Study of a Home-Based Exercise Intervention Program for Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Androgen Deprivation Therapy (ADT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Percentage of Patients Who Complete the Pre/Post Exercise Intervention Testing.
研究概览
简要总结
This single arm, multi-site pilot study aims to evaluate the feasibility of recruiting and adherence to a 12 week home-based exercise intervention to be conducted in men with metastatic castration resistant prostate cancer (mCRPC) receiving androgen deprivation therapy (ADT). Thirty patients will be enrolled, with the expectation that 20-25 will complete all follow-up measures.
详细描述
The purpose of this trial is to evaluate the feasibility and adherence to a home-based 12 week exercise intervention in mCRPC patients receiving ADT. It will also examine if a home-based exercise intervention can improve muscle strength, body composition, physical function, cardiopulmonary function fatigue, and patient reported outcomes (fatigue, depression, quality of life (QoL)).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Metastatic disease that has progressed despite castrate levels of testosterone (surgically or medically castrated, with testosterone levels of < 50 ng/dL) receiving ADT. This will be verified by assessing total testosterone levels within 4 weeks prior to enrollment.
- •No current chemotherapy.
- •Patients may be receiving additional hormonal therapy agents including but not limited to antiandrogens (e.g. bicalutamide, enzalutamide) and CYP17 inhibitors (e.g. abiraterone).
- •Ability to engage safely in moderate exercise as determined by their treating physician.
- •Not previously engaged in regular exercise training (<3 or more d/wk for > 30 min/d or <90 mins per week total including strength training, aerobic training, or walking) in the past 6 months.
- •Access to a computer or a smart phone for syncing and uploading wearable activity data.
- •Be able to speak and read English.
排除标准
- •Any condition that causes severe pain with exertion.
- •History of bone fractures.
- •Active cardiovascular disease including any of the following:
- •New York Heart Association (NYHA) Grade II or greater congestive heart failure .
- •History of myocardial infarction or unstable angina within 6 months prior to Day
- •History of stroke or transient ischemic attack within 6 months prior to Day
- •Acute or chronic respiratory disease that is severe enough to compromise the ability of the participant to safely engage in exercise training protocol.
- •Acute or chronic bone/joint/muscular abnormalities compromising their ability to exercise.
- •Neurological conditions that affect balance and, or muscle strength.
- •Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent.
结局指标
主要结局
Percentage of Patients Who Complete the Pre/Post Exercise Intervention Testing.
时间窗: 12 weeks after baseline testing
To estimate the feasibility of a 12 week, home-based exercise intervention in metastatic castrate resistant prostate cancer (mCPRC) patients undergoing androgen deprivation therapy by reporting the percentage of patients who complete the pre/post testing following the intervention. This was calculated as the number of subjects who completed the trial compared to the total number who completed baseline testing.
次要结局
- Patient Reported Outcomes: Depression(12 weeks after baseline testing)
- Lean Mass(12 weeks after baseline testing)
- Physical Function: 6m Walk(12 weeks after baseline testing)
- Muscle Quality(12 weeks after baseline testing)
- Chest Press Maximal Strength(12 weeks after baseline testing)
- Chest Press Muscle Endurance(12 weeks after baseline testing)
- Fat Mass(12 weeks after baseline testing)
- Physical Function: Timed Up and Go(12 weeks after baseline testing)
- Patient Reported Outcomes: Quality of Life(12 weeks after baseline testing)
- Muscle Size (Cross-sectional Area)(12 weeks after baseline testing)
- Leg Press Muscle Endurance(12 weeks after baseline testing)
- Adherence to the Intervention(12 weeks after baseline testing)
- Patient Reported Outcomes: Fatigue(12 weeks after baseline testing)
- Cardiopulmonary Function(12 weeks after baseline testing)
- Physical Function: Stair Climb(12 weeks after baseline testing)
- Physical Function: 400m Walk(12 weeks after baseline testing)
- Patient Reported Outcomes: Anxiety(12 weeks after baseline testing)
- Leg Press Maximal Strength(12 weeks after baseline testing)
- Percent Body Fat(12 weeks after baseline testing)