NCT04044963 The Effect of a Prehabilitation Exercise Program on Physical Functioning for Patients Undergoing Kidney Transplantation
| NCT ID | NCT04044963 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | End Stage Renal Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2019-08-27 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2019-08-27 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pre-operative physical functioning has been acknowledged as a factor influencing post-operative complication risk, recovery progression and mortality risk. Current guidelines have yet to focus on the pre-operative period as a potential target to improve levels of physical functioning before renal transplantation. This project proposes the introduction of an exercise intervention pre-operatively to mitigate functional decline pre-operatively and improve post-operative outcomes following renal transplantation. We hypothesize that a home-based exercise prehabilitation program prior to kidney transplantation will result in improved functional outcomes including the 6-minute walk test, 60-second timed sit to stand, Fried Frailty Score, quality of life and fatigue. Further we hypothesize that prehabilitation will result in improved outcomes regarding post-operative recovery, complication rate, length of stay and mortality. Objectives A) Identify whether a prehabilitation program can mitigate functional decline pre-operatively regarding walking speed, strength, endurance, quality of life and fatigue B) To determine whether a tailored home-based exercise program prior to kidney transplantation is feasible with regards to adherence in patients with Chronic Kidney Disease (CKD) and End Stage Renal Disease (ESRD). C) To determine if a prehabilitation program results in improved clinical outcomes within one week following Kidney Transplantation (KT) as well as at 30 and 90 days including but not limited to time to first ambulation, time to first bowel movement, postoperative complications (Clavien-Dindo classification), mortality and length of stay. D) Quantify the differences described above, if any exist.
Eligibility Criteria
Inclusion Criteria: 1. Ability to physically participate in a home-based prehabilitation program and all functional outcome measures 2. Ability to read and write in English to respond to study questionnaires 3. Age = to or \> 19 and any gender 4. Receiving care at Vancouver General Hospital or St. Paul's Hospital 5. Has been fully worked up for suitability for renal transplantation 6. Received physician clearance to participate Exclusion Criteria: 1. Unstable pulmonary or symptomatic cardiac disease 2. Recent fracture or acute musculoskeletal injury that precludes the ability to exercise 4\. Is unable to understand the purpose of the study, or cannot give written consent
Contact & Investigator
Christopher Nguan, MD
PRINCIPAL INVESTIGATOR
University of British Columbia
Frequently Asked Questions
Who can join the NCT04044963 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying End Stage Renal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04044963 currently recruiting?
Yes, NCT04044963 is actively recruiting participants. Contact the research team at chris.nguan@ubcurology.com for enrollment information.
Where is the NCT04044963 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT04044963 clinical trial?
NCT04044963 is sponsored by University of British Columbia. The principal investigator is Christopher Nguan, MD at University of British Columbia. The trial plans to enroll 150 participants.