PRO-Active Rehabilitation Prior to Kidney Transplantation to ImproVe Patient-centered Recovery Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Enrollment
研究概览
简要总结
The PRO-Active rehabilitation prior to Kidney Transplantation to ImproVe patient-centered recovery Evaluation trial tests an approach where people are supported to exercise, improve diet, and receive emotional support at home before and after kidney transplant surgery to understand the ideal process and benefits.
详细描述
Background: Many Canadians are waiting for a kidney transplant, using this wait time to improve health before surgery could mean better outcomes. Proactive rehabilitation (pro-hab) is an approach where people are supported to exercise, improve their diet, and have emotional support before surgery, and during their recovery at home.
Overarching Aim: The PROAKTIVE Pilot Trial will test an approach where people are supported to exercise, improve diet, and receive emotional support at home before and after kidney transplant surgery to understand the ideal process and benefits.
Methods:
Design, setting and participants: The PROAKTIVE Pilot trial is a single arm, prospective trial design where eligible participants are enrolled into the pro-hab program.
People >/= 18 years old who will undergo kidney transplant surgery will be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Scheduled, or on the pathway, for kidney transplant surgery
- •Expected surgery date between at least 4 weeks from enrollment
- •Access to internet-enabled device
- •Email address
排除标准
- •Inability to read and communicate in English
- •Cognitive impairment preventing ability to provide informed consent independently
- •No telephone/cell phone
- •Any of the following cardiovascular conditions:
- •Severe valvular heart disease that limits a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea
- •Severe cardiac dysrhythmias that limit a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea
- •Recent myocardial infarction (within 6 weeks prior to enrollment - based on the Heart and Stroke Foundation's HeartWalk program)
结局指标
主要结局
Enrollment
时间窗: One month
\>40% of eligible participants enroll (4/month) would allow us to complete a fully powered (n=312) patient trial in 24 months.
Adequate pro-hab program adherence
时间窗: A minimum of 4 weeks before surgery and 18 weeks after discharged from surgery
\>75% adherence is required to meaningfully benefit from multimodal health-promotion interventions.
Adequate patient-reported outcome follow up
时间窗: One year
\>90% complete outcome ascertainment ensures a low risk of bias trial in terms of non-missing data
次要结局
未报告次要终点