Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change from Baseline in Physical Performance at 12 weeks
研究概览
简要总结
This research study is evaluating the impact and feasibility of a 12-week brisk walking and moderate strength training exercise intervention including a virtual component in men who are initiating androgen deprivation therapy (ADT) for prostate cancer
详细描述
Androgen deprivation therapy (ADT) is a key treatment of prostate cancer. While this therapy improves prostate cancer outcomes, ADT also has a variety of short- and long-term adverse effects, including increased body weight, loss of lean muscle mass, reductions in quality of life, and increased risk of cardiovascular disease. Studies have shown that among men with prostate cancer, physical activity is associated with improved outcomes, including a reduced risk of mortality, from prostate cancer and other causes. Our hypothesis is that physical activity will improve some of the physical and emotional side effects associated with ADT. Physical activity, such as brisk walking and moderate strength training, offers a lifestyle factor that may improve some of the side effects, and is low-cost and easy to do.
The investigators are conducting this study to evaluate the impact and feasibility of a 12-week moderate-intensity aerobic and strength training exercise intervention, including a virtual component. The intervention includes brisk walking and moderate strength training, and involves home-based exercises, in-person sessions with an oncology-trained exercise physiologist, optional group training sessions, and weekly training goals. Participants will have access to a personalized web-based platform called Postwire, which will include videos of training sessions, and will allow participants to easily communicate with the study staff and with other study participants.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Written informed consent prior to any study-related procedures
- •History of histologically confirmed prostate cancer
- •Initiating or within 30 days of initiating ADT
- •ECOG performance status of 0 or 1
- •At least 18 years old and no older than 80 years
- •Physically able to exercise and have physician consent from their treating physician to start a physical activity program
- •English speaking and able to read English
- •Have access to and are able to use the internet at a minimum of once per week
- •Sufficient proficiency and confidence to use the internet and follow video-based instructions, as determined by the eligibility questionnaire to be completed by the participant
- •Willingness to be randomized
排除标准
- •Self-reported inability to walk 2 blocks (at any pace)
- •Currently physically active (> 90 minutes of moderate or vigorous physical activity per week) as determined by Leisure Score Index of Godin Leisure-Time Exercise Questionnaire [LSI])
- •Previously on ADT
- •Radiologic evidence of distant disease
- •Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
- •Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g., untreated major depression or psychosis, substance abuse, severe personality disorder)
结局指标
主要结局
Change from Baseline in Physical Performance at 12 weeks
时间窗: Baseline and 12 weeks
The 6 Minute Walk Test will be performed at the clinic, where the participants will wear tennis shoes and will walk indoors on a flat surface for 6 minutes.
Change from Baseline in Body Composition at 12 weeks
时间窗: Baseline and 12 weeks
Obtain body composition (total fat and lean body mass) by conducting dual energy X-ray absorptiometry (DEXA) scans.
Change from Baseline in Blood Pressure at 12 weeks
时间窗: Baseline and 12 weeks
The investigators will obtain participant's blood pressure from the most recent clinical visit.
Change from Baseline in Physiologic Measurements at 12 weeks
时间窗: Baseline and 12 weeks
Measuring heart rate and resting pulse by counting the number of beats per minute at the wrist of each participant.
次要结局
- Minutes of Physical Activity(Baseline and 12 weeks)
- Physical Functioning(Baseline and 12 weeks)
- Fatigue(Baseline and 12 weeks)
- Measure adherence(Baseline and 12 weeks)
- Measure feasibility(Baseline and 12 weeks)
- Anthropometric Measures(Baseline and 12 weeks.)
- Biomarkers(Baseline and 12 weeks.)
研究者
Paul Nguyen, MD
Principal Investigator
Dana-Farber Cancer Institute