Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT06302205
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2023-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Study Overview
Official Title:
A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity - a Monocenter Randomized Controlled Trial [PHOENIX-Liver]
Status:
RECRUITING
Status Verified Date:
2023-11
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:
PHOENIX-L
Brief Summary:
Research demonstrated that transplant recipients benefit from physical activity, but there is a gap in knowledge regarding the required intensity. In the PHOENIX-Liver study, researchers aim to investigate the adequate intensity of rehabilitation programs after liver transplantation. Patients will be randomized into one of the three PHOENIX-Liver training groups (low, moderate, moderate to high). The six months rehabilitation program is conducted from the patient's home but supervised by a PHOENIX-investigator.
At baseline, after three months of rehabilitation and after six months of rehabilitation, a test moment takes place at which physical fitness, cardiovascular health, liver function, and body composition will be assessed. Questionnaires are taken monthly to survey well-being, safety, quality of life, physical activity, and cost-effectiveness.
To gather information on the potential for implementation in a real-world setting, a 15-month-long physical activity phase will start after the intervention phase. This entails a maintenance physical activity program tailored to the patients' preferences. A follow-up at UZ Leuven is planned at three and at 15 months where the same clinical evaluations will be conducted as during the test moments of the intervention phase.
At baseline, after three months of rehabilitation and after six months of rehabilitation, a test moment takes place at which physical fitness, cardiovascular health, liver function, and body composition will be assessed. Questionnaires are taken monthly to survey well-being, safety, quality of life, physical activity, and cost-effectiveness.
To gather information on the potential for implementation in a real-world setting, a 15-month-long physical activity phase will start after the intervention phase. This entails a maintenance physical activity program tailored to the patients' preferences. A follow-up at UZ Leuven is planned at three and at 15 months where the same clinical evaluations will be conducted as during the test moments of the intervention phase.
Detailed Description:
Liver transplantation constitutes the only curative treatment for patients with end-stage liver disease. Advances in the field have led to favourable short- and medium term (1-3 year) post-transplant survival rates, but improvement in long-term survival rates remains disappointing. Due to the immunosuppressive therapy, a sedentary lifestyle and a poor recovery of post-transplant physical fitness, the proportion of liver transplant recipients that develop a new-onset or a deteriorating unfavourable cardiovascular risk profile is alarmingly high, and cardiovascular disease is the leading cause of death in this population. By consequence, in order to improve long-term outcome after liver transplantation, prevention of cardiovascular disease should be prioritized. The investigators are convinced that the challenge of cardiovascular disease and lack of physical fitness in liver transplant recipients should and can be addressed by subjecting these patients to a structured physical rehabilitation program. The aim of this project is implement a structured, individually-tailored, home-based but supervised physical rehabilitation and maintenance program for de novo liver transplantation recipients, and to demonstrate the feasibility and safety of such approach as well as its efficacy to improve physical fitness. The program will consist of a 2-phase intervention of i) home-based exercise training (aerobic exercise training as well as strength, flexibility and stability exercises under in-person and subsequently remote guidance) and ii) an 15-month maintenance phase of physical activity. This program will be studied in an open-label randomized trial where the regimen will be compared with a regimen of standard of posttransplant care. In addition to the interventional arm, two different regimens of exercise training intensity will also be studied.
Study Oversight
Has Oversight DMC:
True
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?: