Diet and Exercise Frailty Intervention in Cardiac Device Patients Trial Pilot
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Rate of identification of eligible patients
研究概览
简要总结
DEFINIT-P is a prospective pilot study of frailty in cardiac device recipients, comprised of a registry and randomized control trial. The RCT is a supervised exercise program and nutritional supplement intervention for pre-frail and frail cardiac device participants. The registry will be used to describe all cardiac device recipients, regardless of frailty status.
详细描述
DEFINIT-P is a single center randomized controlled trial and registry.
This pilot study will determine the feasibility of a larger, multi-center randomized clinical trial which aims to evaluate the efficacy of a supervised exercise program and nutritional supplement program in reversing or preventing progression of frailty in cardiac device recipients.
The future trial would also examine the physiologic effects of exercise and nutritional supplementation to understand their effects on blood biomarker profiles, which will provide insight into potentially targetable mechanisms underlying frailty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Rate of identification of eligible patients
时间窗: 1 year
The primary outcome will be the number of patients that meet eligibility criteria.
The change in the rate of adherence to the trial interventions from baseline to 12 months
时间窗: 3 months, 6 months, 1 year
The intervention adherence of both the exercise intervention and nutritional supplement
The proportion of eligible patients consenting to participate and randomized
时间窗: 1 year
The number of eligible patients that agree to participate in the randomized control trial and the number of eligible patients that consent to participate in the observational trial
Barriers and facilitators of adherence to the intervention
时间窗: 1 year
The identification of barriers to exercise and nutritional supplement adherence
次要结局
- Physical activity levels as measured by the cardiac device (Permanent pacemaker or Implantable cardioverter defibrillator)(1 year)
- Myocardial infarction, stroke, heart failure hospitalization, atrial fibrillation or ventricular tachyarrhythmia(1 year)
- Injury from a fall or fractures(1 year)
- Frailty biomarker levels(1 year)
- Cardiac device complications(1 year)