Chronic Liver Disease and CirrhosisNCT06163001
Role of Exercise in Chronic Liver Disease Patients Undergoing Liver Transplantation
A study testing Supervised aerobic and resistance exercises and Dietary supplementation in people with Chronic Liver Disease and Cirrhosis and Frailty, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease and Cirrhosis, Frailty
- What is being tested?
- Supervised aerobic and resistance exercises and Dietary supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 15 Dec 2023to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
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
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.
Read more
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.
Read the detailed description
- 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).
- 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 3.9 ± 0.3*, 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 1:1 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, AKI/HRS. 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.
- 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.
- Conditions
- Chronic Liver Disease and Cirrhosis, Frailty
- Being tested
- Supervised aerobic and resistance exercises, Dietary supplementation
- Keywords
- exercise
- Medical subject headings
- Fibrosis, Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised aerobic and resistance exercisesBehavioural
Also called physiotherapy, exercise therapy
4 weeks of preoperative supervised aerobic and resistance exercises
Dietary supplementationDietary supplement
4 weeks of preoperative Standard medical therapy which will consist of dietary advice and supplementation
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Not described Receives: Behavioral: Supervised aerobic and resistance exercises; Dietary Supplement: Dietary supplementation |
| Dietary supplementation | Active comparator | Not described Receives: Dietary Supplement: Dietary supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4 weeks post intervention, Post op day 14, Post op day 30
pulmonary function test
PEF would be tested
Measured: 4 weeks post intervention, Post op day 14, Post op day 30
pulmonary function test
FEV1 would be tested
Measured: 4 weeks post intervention, Post op day 14, Post op day 30
Secondary outcomes (12)
Time to extubation
Measured: Till Post op day 90
Need for re-intubation
Measured: Till Post op day 90
Duration of NIV support
Measured: Till Post op day 90
Mortality
Measured: 90 days
Myostatin levels in blood
Measured: Post intervention at 4 weeks & on Post op day 14
Skeletal muscle mass- L3 Skeletal Muscle Index
Measured: Post intervention at 4 weeks & on Post op day 14
Time to mobilization out of bed
Measured: Till Post op day 90
Length (Days) of ICU stay
Measured: Till Post op day 90
Number of days of hospital stay
Measured: Till Post op day 90
Incidence of all septic complications
Measured: Till Post op day 90
Major surgical complications (CDC > grade 3)
Measured: Till Post op day 90
Pulmonary complications- Clinical evaluation
Measured: Till Post op day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start15 Dec 2023
- Primary completion31 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver Disease and CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Viniyendra Pamecha, MS FEBS FRCS(UK), Study chair, Professor and HOD HPB Surgery and Liver Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163001
- Sponsor's protocol ID
- ILBS-LDLT-02
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2023
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06163001
- Acronym / sponsor ID
- ILBS-LDLT-02
- Conditions
- Chronic Liver Disease and Cirrhosis, Frailty
- Keywords
- exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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).
- 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 3.9 ± 0.3*, 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 1:1 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, AKI/HRS. 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: Supervised aerobic and resistance exercises, Dietary Supplement: Dietary supplementation |
| Dietary supplementation | Active comparator | Dietary Supplement: Dietary supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Voluntary adult patient (>18 years), decompensated chronic liver disease patients planned for LDLT, and Who pass the screening tests done in the OPD
Key exclusion criteria (11 listed)
- 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-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised aerobic and resistance exercisesAlso: physiotherapy, exercise therapy4 weeks of preoperative supervised aerobic and resistance exercises | Behavioural | Exercise Group |
| Dietary supplementation4 weeks of preoperative Standard medical therapy which will consist of dietary advice and supplementation | Dietary supplement | Dietary supplementation, Exercise Group |
Primary outcome
Liver frailty index
Time frame: 4 weeks post intervention, Post op day 14, Post op day 30
Robust defined as LFI <3.2, prefrail defined as LFI between 3.2 and 4.4, and frail defined as LFI ≥4.5
short physical performance battery
Time frame: 4 weeks post intervention, Post op day 14, Post op day 30
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
pulmonary function test
Time frame: 4 weeks post intervention, Post op day 14, Post op day 30
PEF would be tested
pulmonary function test
Time frame: 4 weeks post intervention, Post op day 14, Post op day 30
FEV1 would be tested
12 secondary outcomes
Time to extubation
Time frame: Till Post op day 90
Need for re-intubation
Time frame: Till Post op day 90
Duration of NIV support
Time frame: Till Post op day 90
Mortality
Time frame: 90 days
Myostatin levels in blood
Time frame: Post intervention at 4 weeks & on Post op day 14
Skeletal muscle mass- L3 Skeletal Muscle Index
Time frame: Post intervention at 4 weeks & on Post op day 14
Time to mobilization out of bed
Time frame: Till Post op day 90
Length (Days) of ICU stay
Time frame: Till Post op day 90
Number of days of hospital stay
Time frame: Till Post op day 90
Incidence of all septic complications
Time frame: Till Post op day 90
Major surgical complications (CDC > grade 3)
Time frame: Till Post op day 90
Pulmonary complications- Clinical evaluation
Time frame: Till Post op day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viniyendra Pamecha, MS FEBS FRCS(UK) study chair
Professor and HOD HPB Surgery and Liver Transplantation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised aerobic and resistance exercises and Dietary supplementation in people with Chronic Liver Disease and Cirrhosis and Frailty, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver frailty index (time frame: 4 weeks post intervention, Post op day 14, Post op day 30). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.