Behavioral Exercise Training to Reduce Cardiovascular Disease Risk in Men Undergoing Androgen Deprivation Therapy (EXTRA-PC)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change from baseline in maximal exercise capacity (VO2 peak) at 12 weeks
研究概览
简要总结
To test the preliminary effectiveness of a home-based exercise training (ET) intervention to improve exercise capacity (VO2 peak & 6-minute walk distance [6MWD]) among prostate cancer (PC) patients compared to controls receiving healthy living education (HLE) at 12 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
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Be diagnosed with stage II/III/IV prostate cancer
- •Be currently undergoing treatment with ADT (intermittent or prolonged)
- •Have completed local curative-intent treatment, including prostatectomy or definitive radiation;
- •Be >40 years of age up to 85;
- •Be willing to sign an informed consent with HIPAA authorization form;
- •Not have any hearing or sight impairments that result in the inability to use the telephone or hear normal conversation;
- •Must be able to join an intervention group by personal computer, smartphone or telephone call and should agree to recording of an interview;
- •Be without any serious medical condition that precludes safe participation in an exercise program;
- •Speak English
排除标准
- •Be unable to undergo MRI (i.e., ferromagnetic materials in body, inability to lie flat, claustrophobia);
- •Have contraindications to exercise testing;
- •Have pre-existing overt cardiovascular disease/heart failure;
- •Active illness/infection;
- •Hemoglobin < 7.0 grams/dL
- •Platelet count < 10 x 109/L
研究组 & 干预措施
Exercise Training Intervention
The exercise program (ET) is tailored to each participant depending on his initial functional capacity, cardiorespiratory fitness and strength, to achieve ≥150 moderate to vigorous physical activity
干预措施: Exercise Training Intervention (Behavioral)
Healthy Living Education Control
Educational modules delivered remotely (or manual and telephone call) in a group-based setting to approximately match contact frequency and structure with the ET arm.
干预措施: Healthy Living Education (Behavioral)
结局指标
主要结局
Change from baseline in maximal exercise capacity (VO2 peak) at 12 weeks
时间窗: Baseline, 12 weeks, and 24 weeks
Exercise capacity will be measured by the maximal volume of oxygen utilization (VO2 peak) during a supine graded cardiopulmonary exercise test done in conjunction with cardiac magnetic resonance (exeCMR+CPET). VO2 will be measured in both relative (ml/kg/minute) and absolute (L/minute) terms.
Change from baseline in sub-maximal exercise capacity (6MWD) at 12 weeks
时间窗: Baseline, 12 weeks, and 24 weeks
The distance walked in a sub-maximal 6-minute walk test (6MWD). 6MWD will be reported as meters walked (m).
次要结局
- Change in fat mass(Baseline, 12 weeks)
- Change in physical activity assessed with the Godin Leisure-Time Exercise Questionnaire (GLTEQ)(Baseline, 12 weeks, 24 weeks)
- Left ventricular ejection fraction (LVEF) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.(Baseline, 12 weeks)
- Cardiac output (CO) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.(Baseline, 12 weeks)
- Neighborhood Environment & Walkability Survey (NEWS-A)(Baseline, 12 weeks, 24 weeks)
- Change in physical function measured with the patient reported outcomes measurement information system (PROMIS) - Physical Functioning scores(Baseline, 12 weeks, 24 weeks)
- Change in depressive symptoms measured with the patient reported outcomes measurement information system (PROMIS) - Depression scores(Baseline, 12 weeks, 24 weeks)
- Change in perceived stress as measured with Cohen's perceived stress scale (PSS)(Baseline, 12 weeks, 24 weeks)
- Stroke Volume (SV) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.(Baseline, 12 weeks)
- Arterial-venous oxygen (a-vO2) difference as a musculoskeletal determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.(Baseline, 12 weeks)
- Change in self-efficacy to walk for increasing periods of time.(Baseline, 12 weeks, 24 weeks)
- Change in emotional distress measured with the patient reported outcomes measurement information system (PROMIS) - Emotional Distress scores(Baseline, 12 weeks, 24 weeks)
- Change in fatigue measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale(Baseline, 12 weeks, 24 weeks)
- Change in lean body mass(Baseline, 12 weeks)
- Change in self-efficacy to navigate barriers to engaging in exercise(Baseline, 12 weeks, 24 weeks)
- Change in health-related quality of life (SF-36) scores(Baseline, 12 weeks, 24 weeks)
- Change in Functional Assessment of Cancer Therapy - Prostate (FACT-P) scores(Baseline, 12 weeks, 24 weeks)
- Change in fatigue measured with the patient reported outcomes measurement information system (PROMIS) - Fatigue scores(Baseline, 12 weeks, 24 weeks)
- Change in anxiety measured with the patient reported outcomes measurement information system (PROMIS) - Anxiety scores(Baseline, 12 weeks, 24 weeks)
- Change in physical activity assessed with Accelerometry(Baseline, 12 weeks, 24 weeks)
- Change in sleep disturbance measured with the patient reported outcomes measurement information system (PROMIS) - Sleep Disturbance scores(Baseline, 12 weeks, 24 weeks)
- Change in physical function assessed with the Short Physical Performance Battery (SPPB)(Baseline, 12 weeks, 24 weeks)