| CTRI Number |
CTRI/2026/02/103972 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
12/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effects Of Strength Training Versus Endurance Training On Hepatic Steatosis, Function, Central Adiposity And Quality Of Life In Individuals With Non-Alcoholic Fatty Liver Disease |
|
Scientific Title of Study
|
Effects Of Strength Training Versus Endurance Training On Hepatic Steatosis, Function, Central Adiposity And Quality Of Life In Individuals With Non-Alcoholic Fatty Liver Disease: A Randomized Clinical Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krupa Prabhu |
| Designation |
Postgraduate Student (Orthopaedic Physiotherapy) |
| Affiliation |
KAHER Institute of Physiotherapy, Belagavi |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room
Nagar, Belagavi, Karnataka-590010 Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
590010
India |
| Phone |
9980725555 |
| Fax |
|
| Email |
krupa.prabhu2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kage |
| Designation |
Professor and Dean, Department of Orthopaedic Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy, Belagavi |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room
Nagar, Belagavi, Karnataka-590010 Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Kage |
| Designation |
Professor and Dean, Department of Orthopaedic Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy, Belagavi |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room
Nagar, Belagavi, Karnataka-590010 Belgaum KARNATAKA 590010 India
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@yahoo.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Krupa Prabhu |
| Address |
KAHER Institute of Physiotherapy,Belagavi, Karnataka, India 590010 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Krupa Prabhu |
KLES Dr. Prabhakar Kore Hospital and MRC Nehru Nagar, Belagavi |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced
Physiotherapy Centre Orthopaedic Physiotherapy Department Room
No. 18, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
9980725555
krupa.prabhu2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committe, KLEU Institute of Physiotherapy, Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Endurance Training (Aerobic Exercises) |
Participants will receive a graded aerobic exercise intervention consisting of brisk walking or stationary cycling performed at moderate intensity. The aerobic training will be administered under the supervision of a trained physiotherapist, with intensity monitored using heart rate reserve and perceived exertion. Each session will last 30 minutes, and the intervention will be carried out for 3 sessions per week over a period of 8 weeks, with gradual progression of intensity based on individual tolerance. |
| Intervention |
Strength Training (Calisthenics) |
Participants will receive a graded strength training intervention consisting of structured calisthenics exercises targeting major muscle groups. The program will include body-weight exercises such as squats, lunges, push-ups, glute bridges, and core stabilization exercises, performed at moderate intensity. All exercises will be administered under the supervision of a trained physiotherapist. The intervention will be conducted for 3 sessions per week over a period of 8 weeks, with gradual progression based on tolerance and perceived exertion. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals of all genders aged 25-50 years diagnosed with Non-Alcoholic Fatty Liver Disease by a Gastroenterologist.
2. Ultrasound confirmed Grade 1-2 hepatic steatosis.
3. Body Mass Index (BMI) between 25-35 kg per m2, indicating overweight or class 1 obesity.
4. Elevated or borderline liver enzyme levels ( ALT and or or AST), ALT greater than 56 units per liter and or or AST greater than 40 units per liter.
5. Willingness to participate and provide Informed Consent.
|
|
| ExclusionCriteria |
| Details |
1. Alcohol intake greater than 21 units per week (men) or greater than 14 units per week (women).
2. Other liver diseases or cirrhosis
3. Uncontrolled cardiovascular, respiratory, or endocrine disorders.
4. Participants with a history of regular exercise
5. Musculoskeletal limitations preventing exercise.
6. Use of hepatotoxic or lipid-lowering medications (e.g., corticosteroids, statins)
7. Pregnancy or lactating
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Hepatic steatosis assessed using ultrasonography (USG) through standardized grading of liver echogenicity.
2. Hepatic function evaluated using serum liver enzyme levels (ALT and AST) obtained through laboratory blood tests. |
1. Hepatic steatosis assessed using ultrasonography (USG) through standardized grading of liver echogenicity at baseline and end of 8 weeks.
2. Hepatic function evaluated using serum liver enzyme levels (ALT and AST) obtained through laboratory blood tests at baseline and end of 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Central adiposity assessed using the waist–hip ratio (WHR) measured with a non-elastic measuring tape.
2. Quality of life assessed using the Short Form-36 (SF-36) questionnaire. |
1. Central adiposity (waist–hip ratio) will be assessed pre-intervention & post-intervention, at baseline & end of 8 weeks.
2. Quality of life (SF-36) will be assessed pre-intervention & post-intervention, at baseline & end of 8 weeks. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Non-alcoholic fatty liver disease (NAFLD), recently termed metabolic dysfunction–associated steatotic liver disease (MASLD), is a common metabolic liver disorder associated with obesity, insulin resistance, and increased cardiometabolic risk. Structured exercise is recommended as the primary management strategy; however, evidence comparing different exercise modalities remains limited. This randomized clinical trial aims to compare the effects of strength training (calisthenics) and endurance training (aerobic exercise) on hepatic steatosis, liver function, central adiposity, and quality of life in adults with NAFLD. A total of 36 participants aged 25–50 years will be randomly allocated into two groups, one receiving supervised strength training (calisthenics) and the other receiving supervised aerobic exercise. Both interventions will be administered three times per week for eight weeks. Outcome measures including ultrasound grading of hepatic steatosis, liver enzymes (ALT and AST), waist–hip ratio, and quality of life will be assessed before and after the intervention period. The findings of this study may help identify an effective and accessible exercise-based intervention for the management of NAFLD |