The PROAKTIVE Trial
PRO-Active Rehabilitation Prior to Kidney Transplantation to ImproVe Patient-centered Recovery Evaluation
1 other identifier
interventional
45
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2027
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2026
CompletedFirst Posted
Study publicly available on registry
July 10, 2026
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
Study Completion
Last participant's last visit for all outcomes
March 1, 2029
July 10, 2026
July 1, 2026
1 year
July 6, 2026
July 6, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Enrollment
\>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
\>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
\>90% complete outcome ascertainment ensures a low risk of bias trial in terms of non-missing data
One year
Study Arms (1)
Intervention (Pro-hab)
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel McIsaac, MD
The Ottawa Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2026
First Posted
July 10, 2026
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
March 1, 2029
Last Updated
July 10, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- Time Frame
- Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data.
- Access Criteria
- 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.
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.