The PROAKTIVE Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Inability to read and communicate in English
Cognitive impairment preventing ability to provide informed consent independently
No telephone/cell phone
Severe valvular heart disease that limits a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea
Trial design
Design model
Single group
Treatments tested in this trial
Pro-hab program
BehavioralMultimodal 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.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Intervention (Pro-hab)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Enrollment
\>40% of eligible participants enroll (4/month) would allow us to complete a fully powered (n=312) patient trial in 24 months.
Time frame
One month2
Adequate pro-hab program adherence
\>75% adherence is required to meaningfully benefit from multimodal health-promotion interventions.
Time frame
A minimum of 4 weeks before surgery and 18 weeks after discharged from surgery3
Adequate patient-reported outcome follow up
\>90% complete outcome ascertainment ensures a low risk of bias trial in terms of non-missing data
Time frame
One yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ottawa Hospital Research Institute
Lead sponsor
OHRI ELEVATE Kidney Team Grants Competition
Collaborator
University of Ottawa Anesthesiology and Pain Medicine
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: