NCT06032650

Brief 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; 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 ).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

September 3, 2023

Last Update Submit

January 9, 2024

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

NAFLD , Calisthenics , High intensity interval training

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (5)

  • Body composition analyzer

    up to 8 weeks

  • Waist circumference(WC) and waist hip ratio(WHR)

    up to 8 weeks

  • Functional capacity (VO2)Max

    up to 8 weeks

  • Physical activity level

    up to 8 weeks

  • Level of exertion and fatigue

    up to 8 weeks

Study Arms (2)

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.

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.

Other: Calisthenics exercise and High intensity interval training

Interventions

Calisthenics exercise and High intensity interval trainingOTHER

1. 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

Study group A (Calisthenics exercise)Study group B (High intensity interval training)

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Sixty patients with non-alcoholic fatty liver disease (NAFLD) of both genders.
  • \. 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).
  • \. 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).
  • \. Low levels of physical activity (using the International Physical Activity Questionnaire- Short Version (IPAQ)) ≤ 10 min walking per day.
  • \. Liver size estimated by ultrasonography more than 5% from the normal liver size without hepatocellular damage.

You may not qualify if:

  • 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.
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatma Younis Mahmoud

Giza, 12944, Egypt

RECRUITING

Related Publications (5)

  • 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.

    PMID: 30896648BACKGROUND

  • 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.

    PMID: 14070531BACKGROUND

  • 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.

    PMID: 12360497BACKGROUND

  • 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.

    PMID: 30945129BACKGROUND

  • 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.

    PMID: 28714183BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • 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

    faculty of physical therapy

    STUDY DIRECTOR

  • KHALED Y MOHAMED, Professor

    National research center

    STUDY DIRECTOR

  • MOHAMED K MITKES, Researcher

    National research center

    STUDY DIRECTOR

Central Study Contacts

Fatma Y mahmoud, AI

CONTACT

+201551832272drfatmayounis069@gmail.com

NESREEN G EL-NAHAS, Professor

CONTACT

+201002227242Nessrien.elnahass@pt.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 3, 2023

First Posted

September 13, 2023

Study Start

October 15, 2023

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

January 10, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)