An Exercise Intervention to Mitigate Side-Effects Related to Androgen Deprivation Therapy Among Prostate Cancer Survivors.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Bone Mineral Density
研究概览
简要总结
This main purpose of this study is to examine the effects of an exercise intervention to counteract adverse side effects related to Androgen Deprivation Therapy (ADT) in prostate cancer patients. Specifically, a supervised and home-based exercise program will be used to assess its impact on clinical and behavioral variables related to ADT in prostate cancer patients.
详细描述
This study will assess the feasibility of an exercise intervention to counteract adverse side effects related to ADT in prostate cancer (PCa) patients. Specifically, we will use an exercise intervention and assess its impact on bone mass density, Body Mass Index (BMI), hip/waist circumference levels, biomarkers (i.e., glucose, lipids), step count, grip strength, and health-related quality of life (HRQOL) using the Patient Reported Outcomes Measurement Information System (PROMIS®). In this 8-week two-arm randomized clinical trial, 40 PCa patients receiving ADT will be randomly assigned to an exercise (n=20) or a stretching control group (n=20) with a follow-up at 8-weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •(1) Caucasian or African-American/Black men; (2) histologically confirmed non-metastatic PCa; (3) receiving ADT treatment for 9-months or less upon recruitment (and continue to receive treatment during the duration of the study); (4) 40 to 75 years old; (5) sedentary defined as <60 minutes of recreation or work requiring modest PA/week; (6) ability to perform the level of physical activity assessed by the Physical Activity Readiness Questionnaire (PAR-Q); (6) has access to a smartphone or computer with internet capabilities
排除标准
- •(1) severe cardiac disease; (2) recent myocardial infarction; (3) treated for any other cancer; (4) any physical, psychological illness, and/or medical problems that restricted them from exercise; (5) and not willing or able to follow procedures specified by the study and/or instructions of the researcher.
研究组 & 干预措施
Exercise Group
8-weeks of supervised and home based exercise intervention, 3 times a week, 50-minutes a session for a total of 150/minutes a week
干预措施: Supervised and Home Based Exercise (Behavioral)
Stretching Control group
Informational booklet containing stretching exercises (20-minutes a day)
干预措施: Stretching Control Group (Behavioral)
结局指标
主要结局
Bone Mineral Density
时间窗: 8-weeks
BMD will be measured by a DXA scan
次要结局
- Physical Fitness(8-weeks)
- Muscle strength(8-weeks)
- Step Count(8-weeks)
- Quality of Life (HRQOL)(8-weeks)
- Hip/Waist Circumference(8-weeks)
- Body Mass Index (BMI)(8-weeks)
- Glucose/Lipid levels(8-weeks)