Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06089473
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2023-10-05
Brief Title:
Virtual Home-based Physical Pre-habilitation in Kidney Transplant Candidates
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Virtual Home-based Physical Pre-habilitation in Kidney Transplant Candidates a Pilot RCT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this RCT is to address the feasibility of conducting a 12-week virtual pre-habilitation intervention which includes exercise and education in kidney transplant candidates The intervention also includes a 5-month maintenance phase with independent home exercises maximum of 8 months of interventionended early if the participant undergoes a kidney transplant The main questions it aims to answer are
estimate the proportion of screened patients who meet eligibility criteria
estimate the proportion of eligible patients who consent to randomization
estimate the proportion of patients who adhere to the interventions
estimate follow-up completion rates
inform the calculation of sample size requirements for a full-scale RCT
assess the acceptability of the intervention by the participants
Participants in the control group will receive usual outpatient care
estimate the proportion of screened patients who meet eligibility criteria
estimate the proportion of eligible patients who consent to randomization
estimate the proportion of patients who adhere to the interventions
estimate follow-up completion rates
inform the calculation of sample size requirements for a full-scale RCT
assess the acceptability of the intervention by the participants
Participants in the control group will receive usual outpatient care
Detailed Description:
While waiting for kidney transplant candidates face many challenges related to their physical health These physical impairments are strongly associated with pre- and post-transplant mortality and morbidity Pre-habilitation is the process of enhancing patient functional capacity prior to surgery with the objective of improving tolerance for the stressor In the context of this protocol pre-habilitation is referring to an exercise-based program with education prior to transplant Pre-habilitation has been shown to contribute to a reduction of postoperative recovery time and quicker return to functional ability after thoracic and abdominal surgery There is however limited evidence for the effects of pre-habilitation in kidney transplant candidates
The investigators are following up previous work conducted with a very small n8 pilot pre-post study on pre-habilitation MUHC REB number 2020-5951 specifically with kidney transplant candidates The results were encouraging
The current multicenter pilot randomized controlled trial RCT will address the following research question is it feasible to conduct a full-scale multicenter RCT to assess the comparative effectiveness of a virtual home-based pre-habilitation versus usual care for kidney transplant candidates The investigators specific objectives are to 1 estimate the proportion of screened patients who meet eligibility criteria 2 estimate the proportion of eligible patients who consent to randomization 3 estimate the proportion of patients who adhere to the interventions 4 estimate follow-up completion rates 5 inform the calculation of sample size requirements for a full-scale RCT and 6 assess the acceptability of the intervention by the participants The assessor-blind pilot RCT will be conducted in three hospitals in Canada MUHC CHUM and University of Alberta Hospital Eligible subjects will be randomized 11 to receive either i virtual home-based multimodal pre-habilitation plus usual outpatient care or ii usual outpatient care Participants will be drawn from the transplant clinics at the 3 sites and the investigators aim to recruit 30 participants 22 of which will be recruited from MUHC over 9 months
While some of the assessment appointments will be in person the intervention is virtual so as not to burden the participants with extra hospital visits The exercise portion of the study will include a 12-week virtual home-based supervised exercise program and a 5-month maintenance phase with independent home exercises maximum of 8 months of interventionended early if the participant undergoes transplantation Participants in the intervention group will also watch short educational videos about their kidney assessment and waitlist surgery and recovery medication and their new life after transplantation Additionally participants will be provided a document PDF of evidence-based strategies to help cope with stress
Patients in the control group will receive usual outpatient care All participants in the control group will receive educational resources received by intervention group participants at trial completion
All participants will undergo a nutrition screening and will complete questionnaires regarding anxiety and depression The corresponding transplant team will be notified should participants score abnormal on these assessment tools Additionally all study participants will be asked questions regarding the following whether they have had previous nutritional counselling or received any nutritional interventions whether they have nutritional concernsneeds whether they face any challenges in maintaining a balanced diet whether they have had previous psychological counseling as part of the transplant assessment This information will be collected as part of a needs assessment to inform inclusion of a nutritional and psychological interventions in subsequent trials
The investigators are following up previous work conducted with a very small n8 pilot pre-post study on pre-habilitation MUHC REB number 2020-5951 specifically with kidney transplant candidates The results were encouraging
The current multicenter pilot randomized controlled trial RCT will address the following research question is it feasible to conduct a full-scale multicenter RCT to assess the comparative effectiveness of a virtual home-based pre-habilitation versus usual care for kidney transplant candidates The investigators specific objectives are to 1 estimate the proportion of screened patients who meet eligibility criteria 2 estimate the proportion of eligible patients who consent to randomization 3 estimate the proportion of patients who adhere to the interventions 4 estimate follow-up completion rates 5 inform the calculation of sample size requirements for a full-scale RCT and 6 assess the acceptability of the intervention by the participants The assessor-blind pilot RCT will be conducted in three hospitals in Canada MUHC CHUM and University of Alberta Hospital Eligible subjects will be randomized 11 to receive either i virtual home-based multimodal pre-habilitation plus usual outpatient care or ii usual outpatient care Participants will be drawn from the transplant clinics at the 3 sites and the investigators aim to recruit 30 participants 22 of which will be recruited from MUHC over 9 months
While some of the assessment appointments will be in person the intervention is virtual so as not to burden the participants with extra hospital visits The exercise portion of the study will include a 12-week virtual home-based supervised exercise program and a 5-month maintenance phase with independent home exercises maximum of 8 months of interventionended early if the participant undergoes transplantation Participants in the intervention group will also watch short educational videos about their kidney assessment and waitlist surgery and recovery medication and their new life after transplantation Additionally participants will be provided a document PDF of evidence-based strategies to help cope with stress
Patients in the control group will receive usual outpatient care All participants in the control group will receive educational resources received by intervention group participants at trial completion
All participants will undergo a nutrition screening and will complete questionnaires regarding anxiety and depression The corresponding transplant team will be notified should participants score abnormal on these assessment tools Additionally all study participants will be asked questions regarding the following whether they have had previous nutritional counselling or received any nutritional interventions whether they have nutritional concernsneeds whether they face any challenges in maintaining a balanced diet whether they have had previous psychological counseling as part of the transplant assessment This information will be collected as part of a needs assessment to inform inclusion of a nutritional and psychological interventions in subsequent trials
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None