CompletedNot Applicable

Role of Exercise in Chronic Liver Disease Patients Undergoing Liver Transplantation

India60 participantsStarted 2023-12-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Able to follow the introductory level exercises as per the protocol in the OPD without any adverse event.
. No drop in the spO2 less than 93% on a 6 minute walk test.

Exclusion criteria

. Patients with a physical disability (upper or lower limb deformity/abnormality)
. Exercise intolerance or inability to follow exercise regime.
. Patients who fail the screening tests.
. Patients on the following drugs-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Liver frailty index

Timeframe: 4 weeks post intervention, Post op day 14, Post op day 30

short physical performance battery

Timeframe: 4 weeks post intervention, Post op day 14, Post op day 30

pulmonary function test

Timeframe: 4 weeks post intervention, Post op day 14, Post op day 30

pulmonary function test

Timeframe: 4 weeks post intervention, Post op day 14, Post op day 30

Trial details

NCT IDNCT06163001

SponsorInstitute of Liver and Biliary Sciences, India

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Chronic Liver Disease and Cirrhosis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Able to follow the introductory level exercises as per the protocol in the OPD without any adverse event.
. No drop in the spO2 less than 93% on a 6 minute walk test.

Exclusion criteria

. Patients with a physical disability (upper or lower limb deformity/abnormality)
. Exercise intolerance or inability to follow exercise regime.
. Patients who fail the screening tests.
. Patients on the following drugs-

What they're measuring

Liver frailty index

Timeframe: 4 weeks post intervention, Post op day 14, Post op day 30

short physical performance battery

Timeframe: 4 weeks post intervention, Post op day 14, Post op day 30

pulmonary function test

Timeframe: 4 weeks post intervention, Post op day 14, Post op day 30

pulmonary function test

Timeframe: 4 weeks post intervention, Post op day 14, Post op day 30