Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy: POWER Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Cardiovascular disease risk factors
研究概览
简要总结
The purpose of this research is to determine whether a 16-week culturally tailored, technology-based, aerobic and resistance exercise intervention improves cardiovascular risk factors in Black men diagnosed with prostate cancer and are undergoing androgen deprivation therapy (ADT), and whether it will also improve physical fitness and function, body composition, and outcomes such as quality of life, cancer symptoms, and self-esteem.
Participants in this study will be randomly assigned to one of two groups: 1) Aerobic and resistance exercise, or 2) Usual care.
详细描述
The research study procedures include: screening for eligibility, study intervention, and evaluation of blood markers (blood draw), body composition, cardiorespiratory fitness, muscular strength, and surveys at study entry and follow-up visit.
Participants in this study will be randomly assigned to one of two groups: 1) Aerobic and resistance exercise, or 2) Usual care.
- Aerobic and resistance exercise - virtually supervised 16-week aerobic and resistance exercise performed at home via Zoom.The exercise group will be asked to perform exercise at home with virtual supervision, including aerobic exercise. The exercises will be performed three times per week for 16 weeks, and virtually supervised by a professional exercise trainer.
- Usual care - maintenance of baseline exercise levels for 16 weeks with an offer to perform the same exercise program after 16 weeks. The usual care group will be asked to maintain their current exercise levels and will be offered the same exercise intervention after the completion of the study.
All participants will undergo two testing visits throughout the 16-weeks of the study period, with the exercise group part-taking in 1 additional testing visit at week 8 to assess aerobic fitness and muscular strength only.
Participants will be on the research study for 4 months. It is expected that about 62 people will take part in this research study
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all criteria to be eligible, including travel to Dana-Farber Cancer Institute (DFCI) to collect research data to address the study question.
- •Over 18 years old; children under the age of 18 will be excluded due to the rarity of the disease
- •Histologically diagnosed of localized or metastatic prostate cancer
- •Have been receiving androgen deprivation therapy (ADT) (i.e., luteinizing hormone-releasing hormone [LHRH] agonist/antagonist and/or androgen receptor [AR] agonist/antagonist) for at least one month with a plan to continue ADT for at least 4 months at the time of recruitment
- •Self-identify as Black
- •Medically cleared to participate in exercise by their referred physician or a certified clinical exercise physiologist
- •Are without medical conditions that could exacerbate with exercise, such as bone disease (excluding bone metastases) at imminent risk of fracture or uncontrolled cardiopulmonary or metabolic diseases
- •Speak English and/or Spanish
- •Currently participate in less than or equal to 60 minutes of moderate or vigorous structured exercise/week
- •Willing to travel to DFCI for necessary data collection
- •Ability to communicate and complete written forms in English and/or Spanish
排除标准
- •Are not receiving ADT (i.e., LHRH agonist/antagonist and/or AR agonist/antagonist)
- •Pre-existing medical conditions such as uncontrolled cardiopulmonary disease, or metabolic diseases that could exacerbate with exercise
- •Are not English or Spanish speaking
- •Patients with secondary diagnosis (with the exception of basal cell carcinoma)
- •Participate in more than 60 minutes of moderate or vigorous structured exercise/week
- •Unable to travel to DFCI for necessary data collection
- •May not be able to comply with the safety monitoring requirements of the study in the opinion of the investigator.
研究组 & 干预措施
Aerobic and resistance exercise
Virtually supervised 16-week aerobic and resistance exercise performed at home via Zoom.
The exercises will be performed three times per week for 16 weeks, and virtually supervised by a professional exercise trainer.
干预措施: Aerobic and resistance exercise (Other)
Usual care
Maintenance of baseline exercise levels for 16 weeks with an offer to perform the same exercise program after 16 weeks.
干预措施: Usual Care (Other)
结局指标
主要结局
Cardiovascular disease risk factors
时间窗: baseline to 4 months
Framingham Risk Score, an established comprehensive tool for evaluating the risk of developing cardiovascular disease using blood samples (i.e., low-density lipoprotein-cholesterol \[LDL-C\] or total cholesterol \[TC\], high-density lipoprotein-cholesterol \[HDL-C\]), demographic and medical profiles , and lifestyle behaviors (i.e., age, blood pressure, and diabetic and smoking status). The score ranges from -4 to 36 and the 10-year cardiovascular risk will be calculated accordingly (a higher score indicates a higher risk of cardiovascular disease).
次要结局
- Muscular strength(baseline to 4 months)
- Hand grip strength(baseline to 4 months)
- Percent body fat(baseline to 4 months)
- Cardiorespiratory capacity(baseline to 4 months)
- Prostate cancer-specific symptoms - EPIC-26(baseline to 4 months)
- Cancer treatment symptoms - MDASI(baseline to 4 months)
- Short Physical Performance Battery (SPPB)(baseline to 4 months)
- Hip circumference(baseline to 4 months)
- Self-esteem - RSES(baseline to 4 months)
- Percieved implementation outcomes assessed by AIM, IAM, and FIM(baseline to 4 months)
- Fat mass(baseline to 4 months)
- Lean mass(baseline to 4 months)
- Waist circumference(baseline to 4 months)
- Timed-Up-and-Go (TUG)(baseline to 4 months)
- Health-related quality of life - EORTC-QLQ C30(baseline to 4 months)
研究者
Christina Dieli-Conwright, PhD
Principal Investigator
Dana-Farber Cancer Institute