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The PROAKTIVE Trial

2026年7月6日 更新者：Ottawa Hospital Research Institute

PRO-Active Rehabilitation Prior to Kidney Transplantation to ImproVe Patient-centered Recovery Evaluation

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

Intervention: The intervention will be a multimodal pro-hab program delivered for at least 4 weeks prior to transplant and for 18 weeks after discharge from transplant. The program will be supported virtually using an established, non-commercial platform available on computer, tablet or smartphone.

Outcomes and sample size: The outcomes are: enrollment, program adherence, patient-reported outcome follow-up. The sample size for this stage will be 45, which will provide 80% power to rule out <75% adherence (5% significance) based on our past experience achieving 90% adherence in related populations.

Expertise: Our team features multidisciplinary clinical and methodological experts, nationally representative knowledge users and patient representatives.

Expected outcomes: The PROAKTIVE Pilot Trial will develop, evaluate and implement a multimodal proactive rehabilitation (pro-hab) program that effectively improves patient-centered recovery and resource use for patient waiting for, and recovering after, kidney transplantation.

研究类型

介入性

注册 (估计的)

45

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Emily Hladkowicz, PhD
  • 电话号码：18629 613-798-5555
  • 邮箱：emhladkowicz@toh.ca

研究联系人备份

  • 姓名：Daniel McIsaac, MD
  • 电话号码：14169 613-798-5555
  • 邮箱：dmcisaac@toh.ca

学习地点

  • 加拿大
    • Ontario
      • Ottawa、Ontario、加拿大、K1H 8L6
        • The Ottawa Hospital
        • 接触：
        • 首席研究员：
          • Daniel McIsaac, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    1. Severe valvular heart disease that limits a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea
    2. Severe cardiac dysrhythmias that limit a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea
    3. Recent myocardial infarction (within 6 weeks prior to enrollment - based on the Heart and Stroke Foundation's HeartWalk program)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Intervention (Pro-hab)
The intervention is a multimodal pro-hab program delivered for at least 4 weeks prior to transplant and for 18 weeks after discharge from transplant surgery. The program will be supported virtually using an established, non-commercial platform available on computer, tablet or smartphone.
行为的：Pro-hab program
Multimodal pro-hab program delivered for at least 4 weeks prior to transplant and for 18 weeks after discharge from transplant, including exercise, breathing, nutrition, and psychosocial support.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Enrollment
大体时间：One month
>40% of eligible participants enroll (4/month) would allow us to complete a fully powered (n=312) patient trial in 24 months.
One month
Adequate pro-hab program adherence
大体时间：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.
A minimum of 4 weeks before surgery and 18 weeks after discharged from surgery
Adequate patient-reported outcome follow up
大体时间：One year
>90% complete outcome ascertainment ensures a low risk of bias trial in terms of non-missing data
One year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ottawa Hospital Research Institute

合作者

University of Ottawa Anesthesiology and Pain Medicine
OHRI ELEVATE Kidney Team Grants Competition

调查人员

  • 首席研究员：Daniel McIsaac, MD、The Ottawa Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年1月1日

初级完成 (估计的)

2028年1月1日

研究完成 (估计的)

2029年3月1日

研究注册日期

首次提交

2026年7月6日

首先提交符合 QC 标准的

2026年7月6日

首次发布 (实际的)

2026年7月10日

研究记录更新

最后更新发布 (实际的)

2026年7月10日

上次提交的符合 QC 标准的更新

2026年7月6日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • REB # TBD

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Individual participant data, including data dictionaries, will be available. This includes individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). The Study Protocol, Statistical Analysis Plan and Informed Consent Form will also be made available. Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data. Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.

IPD 共享时间框架

Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data.

IPD 共享访问标准

Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.

IPD 共享支持信息类型

  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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