Project 451864
OPAL: Online Prehabilitation for Patients Awaiting Liver transplantation - a multicenter randomized controlled trial to reduce physical frailty and improve health outcomes
OPAL: Online Prehabilitation for Patients Awaiting Liver transplantation - a multicenter randomized controlled trial to reduce physical frailty and improve health outcomes
Project Information
| Study Type: | Unclear |
| Research Theme: | Clinical |
Institution & Funding
| Principal Investigator(s): | Tandon, Puneeta; Mcneely, Margaret L |
| Co-Investigator(s): | Bemeur, Chantal; Brahmania, Mayur; Cutumisu, Maria; Ezekowitz, Justin A; Harback, Katherine; Ismond, Kathleen P; Marquez Azalgara, Vladimir; Prado, Carla M; Rose, Christopher; Round, Jeff; Selzner, Nazia; Spence, John C; Wong, Philip; Yaskina, Maryna |
| Institution: | University of Alberta |
| CIHR Institute: | Nutrition, Metabolism and Diabetes |
| Program: | |
| Peer Review Committee: | Randomized Controlled Trials |
| Competition Year: | 2021 |
| Term: | 4 yrs 0 mth |
Abstract Summary
Physical frailty is common in patients awaiting liver transplantation and has been associated with poor health outcomes. There is promising data from small studies showing that nutrition and exercise therapy improves physical function in patients while they are waiting for a liver transplant. A large-scale, multicentre trial is needed to provide the evidence needed so that pre-habilitation can become part of routine healthcare for patients on the liver transplant wait list. The proposed trial will assess if a 14-week exercise and nutrition program improves physical function in patients listed for liver transplantation. Over 4 years, 221 patients will be recruited from 4 centres across Canada and will be randomized to receive either the exercise and nutrition interventional program or usual care. The primary outcome will be the change in distance walked in 6 minutes between the beginning and end of the study. This is a commonly used measure of physical function that is sensitive to changes and clinically meaningful. We will also measure changes in physical activity (minutes), daily step counts, nutrition intake, health-related quality of life, mental and cognitive health, and post-transplant health-related outcomes. Results will be compared between the intervention and usual care groups. An economic evaluation will compare the costs and benefits of the prehabilitation program versus usual care. This study will be the first multicentre trial to address pre-habilitation in patients awaiting liver transplantation. A feasibility study in early 2021 showed that online delivery of the exercise and nutrition program is preferred by participants and had high rates of adherence across the 14-weeks.
No special research characteristics identified
This project does not include any of the advanced research characteristics tracked in our database.