Non-Alcoholic Fatty Liver DiseaseNCT06032650
Calisthenics Versus High Intensity Interval Training in NAFL
A study testing Calisthenics exercise and High intensity interval training in people with Non-Alcoholic Fatty Liver Disease, run by Cairo University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Calisthenics exercise and High intensity interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2023to Nov 2024
- 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 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- The patient will be excluded if he has one of the following:-
- Unstable cardiovascular problems like arrhythmia and heart failure.
- Active Hepatitis C virus HCV.
- Diabetes mellitus (DM).
- Hypertensive patients (>140/90mmHg).
- Active Smoker.
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- Chronic chest disease.
- Patients on medications affecting muscle power as steroids.
- Auditory and visual problems.
- Pregnancy \& lactation.
- Clinically significant peripheral vascular disease (ABPI < 80 %).
- Patients who take beta-blockers.
- Severe anemia.
- Patients with chronic renal failure.
- Musculoskeletal or neurological limitation to physical exercise.
- Any cognitive impairment that interferes with prescribed exercise procedures.
- .Participation in regular exercise training of any type in the previous 3 months
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Fatma Younis Mahmoud
Giza, 12944
fatma Y mahmoud, ASS-LEC, +201551832272, drfatmayounis069@gmail.com
NESREEN G EL-NAHAS, Prof-D, +201002227242, Nessrien.elnahass@pt.cu.edu.eg
About this study
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 ).
Read the detailed description
- 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.
- Training equipment:-
- 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.
- Weighted vest progressions and elastic bands: - for calisthenics exercise. -Procedure of the study:- -Assessment procedure:-
- 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.
- Anthropometric measurement:
- Body composition analysis: - By using body composition analyzer device (In body 230). The patient will put off his shoes and socks and stand on the device. The device measures his weight and height automatically then the patient will hold the arms of the device to measure total body fat (free fat mass), lean mass and body mass index (BMI). Free fat mass (FM) % 18-24%for men; 25-31%for women and lean mass (LBM) for men 76-82%; for women 69-75% according to The American Council on Exercise (ACE) .
- Waist circumference (WC) and Waist to 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).(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)
- 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:-
- Increase in hepatic echogenicity.
- Decreased penetration of the deep part of the liver.
- Decreased echogenicity of the diaphragm and intrahepatic portal vessels. (Ma et al., 2011)
- 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
- Repetitions: 10-15 for each exercise.
- Sets: 1-3 sets.
- Intensity of exercise: Moderate-intensity strength exercise training (65%-85%) of (HRmax). (Guzel et al .,2012 )
- Duration: 5-10 minutes warming-up in the form of simple stretching exercises .This is followed by the active phase (20 to 30 minutes) during which a 5-10 seconds passive rest will be allowed in-between repetitions and 1-2 minute passive recovery will be permitted in-between sets. There will be also a cooling down phase for 5 minutes simple stretching exercises.
- Frequency: 3 days/week for 8 weeks.
- Progression: the exercise program will be progressed gradually by increasing the number of sets, repetitions and by using elastic bands and weighted vest progression.
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:-
- Warming up period for 5 min at intensity corresponding to 65-75% of heart rate maximum (HRmax).
- Training phase for 30 min divided into four sets of 4-min length each at intensity equals 85- 90% of HRmax interspersed by 3 minutes low intensity walking at the level of 65-75% of HRmax.
- Cooling down period for 5 min of at 50-60% of the HRmax. (El-Deeb et al., 2018)
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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Calisthenics exercise and High intensity interval training
- Keywords
- NAFLD , Calisthenics , High intensity interval training
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calisthenics exercise and High intensity interval trainingOther
- The calisthenics exercise focuses on big muscles and can be combined with breathing exercises and applied rhythmically,10-15 for each exercise,1-3 sets,3 days/week for 8 weeks. It will be progressed gradually by increasing the number of sets, repetitions and by using elastic bands and weighted vest progression.
- High intensity interval training will be on treadmill for eight weeks, three times/week based on the following program:-Warming up period for 5 min at intensity corresponding to 65-75% of heart rate maximum (HRmax).Training phase for 30 min divided into four sets of 4-min length each at intensity equals 85- 90% of HRmax interspersed by 3 minutes low intensity walking at the level of 65-75% of HRmax.Cooling down period for 5 min of at 50-60% of the HRmax
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Calisthenics exercise and High intensity interval training |
| 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. Receives: Other: Calisthenics exercise and High intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 8 weeks
Blood lipid profile
Cholosterol,TAG,HDL,LDLand LDL/HDL ratio
Measured: up to 8 weeks
Secondary outcomes (5)
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).
Measured: up to 8 weeks
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
Measured: 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.
Measured: 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))
Measured: up to 8 weeks
Level of exertion and fatigue
By using borg scale: - to estimate effort, exertion, breathlessness and fatigue during physical work.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start15 Oct 2023
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Younis Mahmoud Abdel-Salam, Cairo University
- Investigators
- Fatma Y mahmoud, AI, Principal investigator, faculty of physical therapyNESREEN G EL-NAHAS, Professor, Study chair, faculty of physical therapyHend A ABD EL-MONAEM, Lecturer, Study director, faculty of physical therapyKHALED Y MOHAMED, Professor, Study director, National research centerMOHAMED K MITKES, Researcher, Study director, National research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032650
- Sponsor's protocol ID
- P.T.REC/012/004531
- Status last verified
- Jan 2024
- First submitted
- 3 Sep 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30896648BRUCE 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.
PubMed 14070531American 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.
PubMed 12360497Brunner 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.
PubMed 30945129Chalasani 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.
PubMed 28714183
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calisthenics Versus High-intensity Interval Exercises on Health-related Outcomes in Patients With Non-alcoholic Fatty Liver
- ClinicalTrials.gov ID
- NCT06032650
- Acronym / sponsor ID
- P.T.REC/012/004531
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- NAFLD , Calisthenics , High intensity interval training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 13 Sep 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.
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 ).
Detailed description
- 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.
- Training equipment:-
- 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.
- Weighted vest progressions and elastic bands: - for calisthenics exercise. -Procedure of the study:- -Assessment procedure:-
- 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.
- Anthropometric measurement:
- Body composition analysis: - By using body composition analyzer device (In body 230). The patient will put off his shoes and socks and stand on the device. The device measures his weight and height automatically then the patient will hold the arms of the device to measure total body fat (free fat mass), lean mass and body mass index (BMI). Free fat mass (FM) % 18-24%for men; 25-31%for women and lean mass (LBM) for men 76-82%; for women 69-75% according to The American Council on Exercise (ACE) .
- Waist circumference (WC) and Waist to 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).(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)
- 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:-
- Increase in hepatic echogenicity.
- Decreased penetration of the deep part of the liver.
- Decreased echogenicity of the diaphragm and intrahepatic portal vessels. (Ma et al., 2011)
- 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
- Repetitions: 10-15 for each exercise.
- Sets: 1-3 sets.
- Intensity of exercise: Moderate-intensity strength exercise training (65%-85%) of (HRmax). (Guzel et al .,2012 )
- Duration: 5-10 minutes warming-up in the form of simple stretching exercises .This is followed by the active phase (20 to 30 minutes) during which a 5-10 seconds passive rest will be allowed in-between repetitions and 1-2 minute passive recovery will be permitted in-between sets. There will be also a cooling down phase for 5 minutes simple stretching exercises.
- Frequency: 3 days/week for 8 weeks.
- Progression: the exercise program will be progressed gradually by increasing the number of sets, repetitions and by using elastic bands and weighted vest progression.
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:-
- Warming up period for 5 min at intensity corresponding to 65-75% of heart rate maximum (HRmax).
- Training phase for 30 min divided into four sets of 4-min length each at intensity equals 85- 90% of HRmax interspersed by 3 minutes low intensity walking at the level of 65-75% of HRmax.
- Cooling down period for 5 min of at 50-60% of the HRmax. (El-Deeb et al., 2018)
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group A (Calisthenics exercise) | Experimental | Other: Calisthenics exercise and High intensity interval trainingGroup (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 | Other: Calisthenics exercise and High intensity interval trainingGroup (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. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- The patient will be excluded if he has one of the following:-
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 |
|---|---|---|
| Calisthenics exercise and High intensity interval training1. The calisthenics exercise focuses on big muscles and can be combined with breathing exercises and applied rhythmically,10-15 for each exercise,1-3 sets,3 days/week for 8 weeks. It will be progressed gradually by increasing the number of sets, repetitions and by using elastic bands and weighted vest progression. 2. High intensity interval training will be on treadmill for eight weeks, three times/week based on the following program:-Warming up period for 5 min at intensity corresponding to 65-75% of heart rate maximum (HRmax).Training phase for 30 min divided into four sets of 4-min length each at intensity equals 85- 90% of HRmax interspersed by 3 minutes low intensity walking at the level of 65-75% of HRmax.Cooling down period for 5 min of at 50-60% of the HRmax | Other | Study group A (Calisthenics exercise), Study group B (High intensity interval training) |
Primary outcome
Liver ultrasound parameters
Time frame: up to 8 weeks
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
Blood lipid profile
Time frame: up to 8 weeks
Cholosterol,TAG,HDL,LDLand LDL/HDL ratio
5 secondary outcomes
Body composition analyzer
Time frame: up to 8 weeks
Waist circumference(WC) and waist hip ratio(WHR)
Time frame: up to 8 weeks
Functional capacity (VO2)Max
Time frame: up to 8 weeks
Physical activity level
Time frame: up to 8 weeks
Level of exertion and fatigue
Time frame: up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Background: PubMed 30896648Abdelbasset 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.
- Background: PubMed 14070531BRUCE 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.
- Background: PubMed 12360497American 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.
- Background: PubMed 30945129Brunner 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.
- Background: PubMed 28714183Chalasani 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.
- 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.
Fatma Y mahmoud, AI principal investigator
faculty of physical therapy
NESREEN G EL-NAHAS, Professor study chair
faculty of physical therapy
Hend A ABD EL-MONAEM, Lecturer study director
faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calisthenics exercise and High intensity interval training in people with Non-Alcoholic Fatty Liver Disease, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 10 Jan 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Y mahmoud, AI (+201551832272, drfatmayounis069@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver ultrasound parameters (time frame: up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06032650, which also lists 5 linked publications.
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 10 Jan 2024.