Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT06032650
Eligibility Criteria:
Inclusion Criteria:
* 1\. Sixty patients with non-alcoholic fatty liver disease (NAFLD) of both genders.
2\. Patients with mild non-alcoholic fatty liver disease (NAFLD) according to ultrasonography fatty liver indicator (US-FLI) score (2-4).( Chen et al.,2020) 3. Their age will be ranged from 30s-40s. 4. Body mass index (BMI) from 30 to 34.9 kg/m2. 5. Body free fat mass (FFM) percentage \> 25 % for men,\> 35 % for women. 6. Lean body mass (LBM) parentage \< 76 % for men; \< 69% for women. 7. Waist circumference ≥ 102 cm for men, \> 88 cm for women. 8. Waist/Hip ratio \> 0.9% for men and \> 0.8% for women. 9. Elevated liver enzymes (ALT\> 55 U/L, AST\> 48 UL, GGT\>85 U/L, AST/ALT \<1 U/L).
10\. Patient with dyslipidemia who has one or more from the following blood lipid values (total cholesterol \> 200 mg\\dl, LDL \> 130 mg\\dl, TG \>150 mg\\dl, HDL\< 40mg\\dl or LDL/HDL ratio \> 4).
11\. Low levels of physical activity (using the International Physical Activity Questionnaire- Short Version (IPAQ)) ≤ 10 min walking per day.
12\. Liver size estimated by ultrasonography more than 5% from the normal liver size without hepatocellular damage.
Exclusion Criteria:
* The patient will be excluded if he has one of the following:-
1. Unstable cardiovascular problems like arrhythmia and heart failure.
2. Active Hepatitis C virus HCV.
3. Diabetes mellitus (DM).
4. Hypertensive patients (\>140/90mmHg).
5. Active Smoker.
6. Chronic chest disease.
7. Patients on medications affecting muscle power as steroids.
8. Auditory and visual problems.
9. Pregnancy \& lactation.
10. Clinically significant peripheral vascular disease (ABPI \< 80 %).
11. Patients who take beta-blockers.
12. Severe anemia.
13. Patients with chronic renal failure.
14. Musculoskeletal or neurological limitation to physical exercise.
15. Any cognitive impairment that interferes with prescribed exercise procedures.
16. .Participation in regular exercise training of any type in the previous 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
45 Years
Study:
NCT06032650
Study Brief:
Protocol Section:
NCT06032650