Non-Alcoholic Fatty Liver Disease Clinical Trial
Official title:
Calisthenics Versus High-intensity Interval Exercises on Health-related Outcomes in Patients With Non-alcoholic Fatty Liver
According to sample size calculation and after achieving the inclusion criteria, sixty patients with non-alcoholic fatty liver (NAFL) of both genders will be enrolled in this study and their ages will be ranged from30s-40s; they will be selected from internal medicine-outpatient clinics, Cairo University Hospitals; they will participate in the study for 8 weeks, and randomly be assigned into two equal groups in number. Group (A) (n =30) will receive calisthenics exercise three times /week for eight weeks, group (B) (n =30) will receive HIIT for three times /week for eight weeks and all patients in both groups will receive their prescribed medication (Statin 5mg ).
Status | Recruiting |
Enrollment | 60 |
Est. completion date | November 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Fatma Younis Mahmoud | Giza |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Abdelbasset WK, Tantawy SA, Kamel DM, Alqahtani BA, Soliman GS. A randomized controlled trial on the effectiveness of 8-week high-intensity interval exercise on intrahepatic triglycerides, visceral lipids, and health-related quality of life in diabetic obese patients with nonalcoholic fatty liver disease. Medicine (Baltimore). 2019 Mar;98(12):e14918. doi: 10.1097/MD.0000000000014918. Erratum In: Medicine (Baltimore). 2020 Sep 11;99(37):e22388. — View Citation
American Gastroenterological Association. American Gastroenterological Association medical position statement: evaluation of liver chemistry tests. Gastroenterology. 2002 Oct;123(4):1364-6. doi: 10.1053/gast.2002.36060. No abstract available. — View Citation
BRUCE RA, BLACKMON JR, JONES JW, STRAIT G. EXERCISING TESTING IN ADULT NORMAL SUBJECTS AND CARDIAC PATIENTS. Pediatrics. 1963 Oct;32:SUPPL 742-56. No abstract available. — View Citation
Brunner KT, Henneberg CJ, Wilechansky RM, Long MT. Nonalcoholic Fatty Liver Disease and Obesity Treatment. Curr Obes Rep. 2019 Sep;8(3):220-228. doi: 10.1007/s13679-019-00345-1. — View Citation
Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi: 10.1002/hep.29367. Epub 2017 Sep 29. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Liver ultrasound parameters | Ultrasonography (USG) (Siemens, ACUSON NX3 ELITE, and German):- to measure size of the liver, thickness of fat outside liver, as well as severity of the fat infiltration
Ultrasound :-(Siemens, ACUSON NX3 ELITE, and German):- to measure size of the liver, thickness of fat outside liver, as well as severity of the fat infiltration |
up to 8 weeks | |
Primary | Blood lipid profile | Cholosterol,TAG,HDL,LDLand LDL/HDL ratio | up to 8 weeks | |
Secondary | Body composition analyzer | In body 230:- It will be used for estimating body composition, to measure the percentage of the body free fat mass, lean body mass and body mass index (BMI). | up to 8 weeks | |
Secondary | Waist circumference(WC) and waist hip ratio(WHR) | Placing a tape horizontal in the midpoint between iliac crest and last rib, and take the measure just after expiration.
Hip circumference will be measured from the widest point of the hip; then dividing waist circumference by hip circumference to calculate waist to hip ratio. According to world health organization, normal cut off values of waist circumference (WC < 88 cm for men; WC < 102 cm or less for women) and waist to hip ratio (WHR < .95 cm for men ; WHR < .80 cm for women |
up to 8 weeks | |
Secondary | Functional capacity (VO2)Max | Using Bruce protocol for multistage treadmill testing of maximal exercise testing will be used as the following 3-min stages: Stage I (2 mph, 10% grade), Stage II (2.5 mph, 12% grade), Stage III (3.4 mph, 14% grade), and Stage IV (4.2 mph, 16%). (Bruce et al., 1963) VO2 max will be estimated from treadmill time based on following equation: For Men VO2 max = 14.8 - (1.379 x T) +(0.451 x T²) - (0.012 x T³) For Women VO2 max = 4.38 x T - 3.9 T = Total time on the treadmill measured as a fraction of a minute i.e.: A test time of 9 minutes 30 seconds would be written as T=9. | up to 8 weeks | |
Secondary | Physical activity level | to assess level of physical activity that patients do as part of their daily lives by using International Physical Activity Questionnaire-Short Version (IPAQ)) | up to 8 weeks | |
Secondary | Level of exertion and fatigue | By using borg scale: - to estimate effort, exertion, breathlessness and fatigue during physical work. | up to 8 weeks |
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