High-Intensity Training for Men With Prostate Cancer on Active Surveillance: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Recruitment rate (feasibility target: ≥25% of eligible patients)
研究概览
简要总结
This is a randomized study aiming to assess the feasibility of a phase II randomized controlled trial of different high-intensity training interventions and usual care (UC) in men with prostate cancer (PCa) undergoing active surveillance (AS).
详细描述
Primary objectives:
The primary objective of this study is to assess the feasibility of conducting a three-armed randomized controlled trial comparing high-intensity interval training (HIIT), high-intensity resistance training (HIRT), and usual care (UC) in men with PCa on AS.
The secondary exploratory objective of this study is to assess changes in cardiorespiratory fitness, musculoskeletal strength, body composition, circulating blood markers, and participant-self-reported outcomes (e.g., quality of life, anxiety, fear of disease progression) after 8 weeks of HIIT, HIRT, or UC.
Methods:
Participants will be randomized in a 1:1:1 ratio to HIIT, HIRT or UC group.
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18 years or older;
- •initiating or currently on AS for PCa;
- •not currently engaging in high-intensity aerobic and/or resistance training at 85%HRmax or ≥9 RPE in the Borg 0-10 RPE scale;
- •willing and able to travel to the study-designated facilities;
- •proficient in English;
- •able to provide written informed consent;
- •pass the screening CPET by achieving volitional exhaustion (rate of perceived exertion (RPE) ≥ 9 using the Borg 0-10 RPE scale) in the absence of any cardiorespiratory abnormalities.
排除标准
- •uncontrolled hypertension (≥2/3 of readings of > 160/90), regardless of whether on a regimen of anti-hypertensive therapy or not;
- •been diagnosed with congestive heart failure (New York Heart Association Class II, III or IV);
- •a history of serious cardiovascular events (within 12 months) including, but not limited to, transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI);
- •a medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the study physician, would make this protocol unreasonably hazardous for the patient;
- •a history of a psychiatric illness, which would prevent the patient from giving informed consent or adhering to the study protocol;
- •serious or non-healing wound, ulcer, or bone fracture;
- •experience shortness of breath, chest discomfort, or palpitations when performing activities of daily living;
- •ongoing restriction of physical activity;
- •developed chest pain in the past month
结局指标
主要结局
Recruitment rate (feasibility target: ≥25% of eligible patients)
时间窗: Initiation through end of study recruitment at 26 months
Percent of consenting participants relative to the total number of eligible participants approached
Compliance rate (feasibility target: ≥70% of the prescribed exercises within supervised sessions)
时间窗: Initiation through end of study intervention period at a maximum of 8 weeks post-randomization
Percent of completed repetitions relative to the total number of prescribed repetitions
Attendance rate (feasibility target: ≥70% to facility-based sessions)
时间窗: Initiation through end of study intervention period at a maximum of 8 weeks post-randomization
Percent of completed facility-based sessions relative to the total number of prescribed facility-based sessions
Retention rate (feasibility target: 70% of participants consented to study)
时间窗: Initiation through end of study intervention period at a maximum of 8 weeks post-randomization
Percent of participants that completed the study relative to the total number of participants consented to the study
次要结局
- Changes in circulating cytokines(At baseline and 8 weeks (post-intervention))
- Changes in cardiorespiratory fitness(At baseline and 8 weeks (post-intervention))
- Body composition(At baseline and 8 weeks (post-intervention))
- Changes in body fat and lean body mass(At baseline and 8 weeks (post-intervention))
- Changes in Quality of Life(At baseline and 8 weeks (post-intervention))
- Physical activity status(At baseline and 8 weeks (post-intervention))
- Changes in musculoskeletal strength(At baseline and 8 weeks (post-intervention))
- Changes in circulating growth factors(At baseline and 8 weeks (post-intervention))
- Changes in waist circumference(At baseline and 8 weeks (post-intervention))
- Anxiety(At baseline and 8 weeks (post-intervention))
- Fear of disease progression(At baseline and 8 weeks (post-intervention))
研究者
Daniel Santa Mina, PhD
Assistant Professor
University of Toronto