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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 ).
A) Evaluation equipment:
All patients will be evaluated before and after treatment protocol.
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).
Fig (1) Body composition analyzer (in body 230)
Mercury and digital sphygmomanometer and stethoscope: it will be used to measure blood pressure. (Niscomed PW-216)
Pulse oximeter: It will be used to monitor heart rate and oxygen saturation continuously during exercise (SantaMedical Generation 2 Fingertip).
Fig (2) Pulse oximeter
Bruce protocol:-to assess functional capacity (Vo2) max and intensity of exercise.
Tape measurement: - to assess waist circumference, waist / hip ratio.
Clini-chem 2 analyzer: - to analyze blood lipid profile and liver enzymes.
Fig (3) Clini-chem 2 analyzer
Abdominal 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.
International Physical Activity Questionnaire-Short Version (IPAQ)):- to assess level of physical activity that patients do as part of their daily lives.
Borg scale: - to estimate effort, exertion, breathlessness and fatigue during physical work.
B. Training equipment:-
A) History and physical examination:
Complete history taking will be conducted to collect data about patient's general condition, physical activity, current medication, and measuring blood pressure.
B) Anthropometric measurement:
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).(World Health Organization .2000) 3- 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=9.5 .(Khurana and Oommen 2016) C) Liver enzymes analysis:- According to American Gastroenterological association ,the normal values of liver enzymes (alanine amino transferase ( ALT) 7-55 U/L, aspartate aminotransferase (AST) 8-48 U/L ,gamma glutamyl transferase (GGT) 9-85U/L ). (American Gastroenterological association. 2002)
D) Blood lipid profile analysis:- According to The National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III), the normal reference range of lipid profile (total cholesterol < 200 mg\dl, low- density lipoprotein cholesterol (LDL-C) <100 mg\dl, triglyceride (TG) <150 mg\dl, high density lipoprotein cholesterol (HDL-C) ≥60mg\dl, LDL/HDL3.5/1 mg\dl). (Cleeman et al., 2001) E) Abdominal Ultrasonography (USG):- A 10 MHZ sonosite 180 plus US sanner (penetration depth of 2.2 cm) will be used, Ultrasonographic findings in the liver will be as the following:-
F) The International Physical Activity Questionnaire-Short Version (IPAQ)):-It is self - report questionnaire, It consists of seven Open-ended questions surrounding individuals' last seven-day recall of physical activity. The IPAQ records the activity of four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting. Appendix II G) Borg scale: - It is a scale of 0-10;. The scale will allow individuals to subjectively rate their level of exertion during exercise or exercise testing. Appendix III (2) Treatment procedure:- Group (A):- that included 30 non-alcoholic fatty liver patients will participate in calisthenics exercise for eight weeks, Three times/week based on the following program:-
Exercise prescription:
Mode of exercise: Strengthening exercise.
Modality of exercise: Bodyweight exercises and require little equipment.
Forms of exercises:
Sit-Ups that work on Lower abs, mid abs, upper abs, hip flexors, chest, shoulders, quads, and hamstrings.
Fig (4) Sit -up exercise
Push-Ups that work on Pectorals (chest), biceps, lats, back and core.
Fig (5) Push-up exercise
3- Plank:-That works on abs, shoulders, back, core and glutes,
Fig (6) Plank exercise
4- Squats that work on quads, hamstring, glutes, lower abs and core.
Fig (7) squat exercise
Group (B): that included 30 non-alcoholic fatty liver patients will participate in high intensity interval training on treadmill for eight weeks, three times/week based on the following program:-
All patients will be trained at the lower intensity limit for the first 2 weeks of the program before increasing the intensity levels toward the upper limit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group A (Calisthenics exercise) | Experimental | Group (A) (n =30) will receive calisthenics exercise three times /week for eight weeks, patients in this group will receive four forms of calisthenics exercise (squats, curl up, push up, blank) starting free and upgrading intensity according to ability of the patients. |
|
| Study group B (High intensity interval training) | Experimental | Group (B) (n =30) will receive high intensity interval training three times /week for eight weeks, A motorized treadmill device (KETTLER, laufband alpha run 600, German) with a minimum speed of 0.5km/hr and capability to display the distance in kilometer per hour will be used in this study. Intensity of HIIT will be measured using Bruce protocol to calculate target heart rate of each patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calisthenics exercise and High intensity interval training | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Blood lipid profile | Cholosterol,TAG,HDL,LDLand LDL/HDL ratio | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Waist circumference(WC) and waist hip ratio(WHR) |
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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:-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatma Y mahmoud, AI | Contact | +201551832272 | drfatmayounis069@gmail.com | |
| NESREEN G EL-NAHAS, Professor | Contact | +201002227242 | Nessrien.elnahass@pt.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Fatma Y mahmoud, AI | faculty of physical therapy | Principal Investigator |
| NESREEN G EL-NAHAS, Professor | faculty of physical therapy | Study Chair |
| Hend A ABD EL-MONAEM, Lecturer |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fatma Younis Mahmoud | Recruiting | Giza | 12944 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30896648 | Background | 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. | |
| 14070531 |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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|
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 |
| 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 |
| 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 |
| Level of exertion and fatigue | By using borg scale: - to estimate effort, exertion, breathlessness and fatigue during physical work. | up to 8 weeks |
| faculty of physical therapy |
| Study Director |
| KHALED Y MOHAMED, Professor | National research center | Study Director |
| MOHAMED K MITKES, Researcher | National research center | Study Director |
| Background |
| 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. |
| 12360497 | Background | 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. |
| 30945129 | Background | 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. |
| 28714183 | Background | 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. |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |