Role of Exercise in Chronic Liver Disease Patients Undergoing Liver Transplantation

NCT06163001 | Completed

• 1 other identifier: ILBS-LDLT-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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
• Standard medical therapy along with supervised aerobic and resistance exercises for 4 weeks.
• 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.

Conditions

Chronic Liver Disease and Cirrhosis; Frailty

Keywords

exercise

Outcome Measures

Primary Outcomes (4)

• Liver frailty index

  Robust defined as LFI \<3.2, prefrail defined as LFI between 3.2 and 4.4, and frail defined as LFI ≥4.5

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

• short physical performance battery

  SPPB scores range from zero to 12 possible points. SPPB score of 3-9 points in persons with possible sarcopenia but no mobility disability indicates frailty; SPPB score of 10 or greater for persons with no sarcopenia and no mobility disability indicates robustness

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

• pulmonary function test

  PEF would be tested

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

• pulmonary function test

  FEV1 would be tested

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

Secondary Outcomes (12)

• Time to extubation

  Till Post op day 90

• Need for re-intubation

  Till Post op day 90

• Duration of NIV support

  Till Post op day 90

• Mortality

  90 days

• Myostatin levels in blood

  Post intervention at 4 weeks & on Post op day 14

Study Arms (2)

Exercise Group

EXPERIMENTAL

Behavioral: Supervised aerobic and resistance exercises; Dietary Supplement: Dietary supplementation

Dietary supplementation

ACTIVE COMPARATOR

Dietary Supplement: Dietary supplementation

Interventions

Supervised aerobic and resistance exercises BEHAVIORAL

4 weeks of preoperative supervised aerobic and resistance exercises

Also known as: physiotherapy, exercise therapy

Exercise Group

Dietary supplementation DIETARY_SUPPLEMENT

4 weeks of preoperative Standard medical therapy which will consist of dietary advice and supplementation

Dietary supplementation; Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary adult patient (\>18 years), decompensated chronic liver disease patients planned for LDLT, and Who pass the screening tests done in the OPD
• 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.

You may not qualify if:

• 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-
• Higher corticosteroid dose (\>0.1mg/kg/day),
• BCAA (Branched chain amino acids)
• Growth hormone, testosterone, SARMs,
• Ghrelin agonists, myostatin antibodies,
• Activin IIR antagonists, angiotensin converting enzyme inhibitors,
• Espindolol (mixed beta agonist and antagonists), and
• Fast skeletal muscle troponin activators.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Fibrosis; Frailty; Motor Activity

Interventions

Physical Therapy Modalities; Exercise Therapy; Dietary Supplements

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Viniyendra Pamecha, MS FEBS FRCS(UK)

  Professor and HOD HPB Surgery and Liver Transplantation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: December 8, 2023
• Study Start: December 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)