The PROAKTIVE Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pro-hab program.
- Who it may be relevant to
- Registry conditions: Kidney Transplant; Complications, Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PRO-Active Rehabilitation Prior to Kidney Transplantation to ImproVe Patient-centered Recovery Evaluation
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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.
Primary outcome measures
- Enrollment [Time frame: One month]
- Adequate pro-hab program adherence [Time frame: A minimum of 4 weeks before surgery and 18 weeks after discharged from surgery]
- Adequate patient-reported outcome follow up [Time frame: One year]
Eligibility criteria
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:
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- The Ottawa Hospital — Ottawa
Identifiers
NCT: NCT07696624 · REB # TBD