Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163001
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-08-28
Brief Title:
Role of Exercise in Chronic Liver Disease Patients Undergoing Liver Transplantation
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
Effects of Supervised Aerobic and Resistance Exercises on Measures of Frailty in Chronic Liver Disease Patients Undergoing Living Donor Liver Transplantation- an Open Label Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
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 randomised clinical trial open label is to test the effect of supervised aerobic and resistance exercises in chronic liver disease patients being planned for living donor liver transplantation LDLT The main question it aims to answer are
If pre-operative supervised aerobic and resistance exercise for 4 weeks can improve the measures of frailty Liver frailty index Short physical performance battery pulmonary function tests in chronic liver disease patients being planned for LDLT
Can this approach also translate into clinically significant benefits in the postoperative outcomes of LDLT
Participants will be randomised into two groups receiving either
1 Standard medical therapy along with supervised aerobic and resistance exercises for 4 weeks
2 Standard medical therapy The two groups will be compared for progression of the measures of frailty ver the course of their participation as well as their post LDLT outcomes
If pre-operative supervised aerobic and resistance exercise for 4 weeks can improve the measures of frailty Liver frailty index Short physical performance battery pulmonary function tests in chronic liver disease patients being planned for LDLT
Can this approach also translate into clinically significant benefits in the postoperative outcomes of LDLT
Participants will be randomised into two groups receiving either
1 Standard medical therapy along with supervised aerobic and resistance exercises for 4 weeks
2 Standard medical therapy The two groups will be compared for progression of the measures of frailty ver the course of their participation as well as their post LDLT outcomes
Detailed Description:
1 Aim and Objective - Primary objective To assess effects of pre-operative aerobic and resistance exercises in decompensated CLD patients planned for LDLT on the measures of frailty after 1 month of supervised exercise
Secondary objectives To assess effects of pre-operative aerobic and resistance exercises in decompensated CLD patients planned for LDLT on the post LDLT outcomes myostatin levels on POD 14 and skeletal muscle mass on POD14
2 Methodology
Study population - Consecutive voluntary adults 18 years with chronic liver disease planned for living donor liver transplantation fulfilling the conditions as per inclusion and exclusion criteria
Study design - Interventional study- Open label randomised controlled trial
Study period - From time of ethical clearance till 31st December 2024
Sample size - Assuming median LFI for CLD patients as 39 03 and assuming an improvement of 5 with introduction of exercise along with SMT after 1 follow up and keeping alpha of 5 and power of study as 90 with 11 ratio of cases and controls then by method of change we need to enroll a total of 54 patients with 27 in each arm Assuming 10 non compliance a total of 60 cases will be enrolled with 30 cases in each arm
Intervention - Pre-operative supervised exercise-based regimen versus standard medical therapy alone for a minimum duration of 4 weeks
Monitoring and assessment - Clinical profile of the patient and symptoms will be serially followed during the patients OPD visits
Adverse effects - Exercise may aggravate encephalopathy metabolic disorders AKIHRS It may also lead to falls due to cardio-pulmonary intolerance or hepatic encephalopathy
Stopping rule - Inability to follow the exercise schedule or development of any of the adverse effects due to exercise as mentioned above
3 Expected outcome of the project Better values of measures of frailty and post LDLT outcomes in patients receiving pre-operative concurrent exerises as an intervention
Secondary objectives To assess effects of pre-operative aerobic and resistance exercises in decompensated CLD patients planned for LDLT on the post LDLT outcomes myostatin levels on POD 14 and skeletal muscle mass on POD14
2 Methodology
Study population - Consecutive voluntary adults 18 years with chronic liver disease planned for living donor liver transplantation fulfilling the conditions as per inclusion and exclusion criteria
Study design - Interventional study- Open label randomised controlled trial
Study period - From time of ethical clearance till 31st December 2024
Sample size - Assuming median LFI for CLD patients as 39 03 and assuming an improvement of 5 with introduction of exercise along with SMT after 1 follow up and keeping alpha of 5 and power of study as 90 with 11 ratio of cases and controls then by method of change we need to enroll a total of 54 patients with 27 in each arm Assuming 10 non compliance a total of 60 cases will be enrolled with 30 cases in each arm
Intervention - Pre-operative supervised exercise-based regimen versus standard medical therapy alone for a minimum duration of 4 weeks
Monitoring and assessment - Clinical profile of the patient and symptoms will be serially followed during the patients OPD visits
Adverse effects - Exercise may aggravate encephalopathy metabolic disorders AKIHRS It may also lead to falls due to cardio-pulmonary intolerance or hepatic encephalopathy
Stopping rule - Inability to follow the exercise schedule or development of any of the adverse effects due to exercise as mentioned above
3 Expected outcome of the project Better values of measures of frailty and post LDLT outcomes in patients receiving pre-operative concurrent exerises as an intervention
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