Interval Training Versus Electro Acupuncture on Liver Functions in Patients With Non-alcoholic Fatty Liver Disease

in this study, the investigators compare the effect of interval training exercise and electroacupuncture on liver functions in non-alcoholic fatty liver disease patients

Study Overview

• Status: Completed
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Behavioral: aerobic interval training exercise .; Device: electro acupuncture

Detailed Description

fifty patients suffering from Nonalcoholic fatty liver disease (NAFLD) will be recruited in this study with age ranged from 30-55 years old from both sexes, chosen from internal medicine department at Kasr El Aini hospital and from the outpatient clinic of nutrition and cardiovascular disorders at the faculty of Physical Therapy Cairo University, they were divided in to two groups:Group (1):

Twenty-five patients suffering from Nonalcoholic fatty liver disease (NAFLD), and taking their standard medications In addition to electroacupuncture at points of LR3 (Taichong), LR14 (Qimen), GB 34(Yanglingquan) and ST36 (Zu San Li). Group (2):

Twenty-five patients suffering from Nonalcoholic fatty liver disease(NAFLD) and taking their standard medications in addition to aerobic interval training exercise.Lab investigations of:

Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Triglycerides (TG) and C-reactive protein (CRP).to judge liver functions

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Physical Therapy Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Sixty patients suffering from Nonalcoholic fatty liver disease (NAFLD).
2. Their age will be ranged from 30-55 years old.
3. Body mass index (30 - 40)
4. All patients are medically stable.

Exclusion Criteria:

• Patients with Hepatitis C & b
• Acute and chronic significant illnesses that may interfere with actual training, severe ventricular arrhythmia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing.
• Co-morbidities that limit exercise tolerance (hemoglobin 10 g/dl, a chronic obstructive pulmonary disease with FEV1 50%).
• Hypertension (resting blood pressure >140/90 mmHg).
• Heart failure, inability to exercise, or drug abuse.
• Pacemakers
• Pregnancy
• Epileptic Seizures
• Cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: exercise group; Twenty-five patients suffering from Nonalcoholic fatty liver disease (NAFLD) and taking their standard medications in addition to aerobic interval training exercise .Its consisted of cycle ergometer training, 3 days a week for 6 weeks. Aerobic interval training consisted of ( 8 )minutes warm-up, followed by 4 times of 4-minute intervals with heart rate (HR) at 85% of sub maximum HR, with active pauses of 3 minutes of walking at 60% of sub maximum heart rate HR. The exercise session was terminated by 5 minutes cool-down	Behavioral: aerobic interval training exercise .; Its consisted of cycle ergometer training, 3 days a week for 6 weeks. Aerobic interval training consisted of ( 8 )minutes warm-up, followed by 4 times of 4-minute intervals with HR at 85% of sub maximum HR, with active pauses of 3 minutes of walking at 60% of sub maximum HR. The exercise session was terminated by 5 minutes cool-down
Active Comparator: electro-acupuncture group; Twenty-five patients suffering from Nonalcoholic fatty liver disease (NAFLD), and taking their standard medications In addition to electro acupuncture (EA) of (2 Hz, 4 mA) was applied at points of: liver 3 (LR3) ,liver 14 (LR14), gall bladder 34 (GB 34) and stomach 36 (ST36) . Duration of the session was 15 min / each, three sessions per week for six weeks	Device: electro acupuncture; electroacupuncture (EA) of (2 Hz, 4 mA) was applied at points of:liver 3 LR3,liver 14 LR 14, gall bladder 34 (GB 34) and stomach 36 (ST36) . Duration of the session was 15 min / each, three sessions per week for six weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body mass index	was used for measuring the weight and height of each patient to calculate the body mass index (BMI) (figure). BMI = weight kg / (height m)2	about 4 weeks
lab investigations	lab investigation of aminotransferase (ALT) iu/l and Aspartate aminotransferase (AST) iu/l There was a subjective evaluation of the level of exhaustion throw observation of ventilation, walking action and fascial expression in patients at the end stage of test.; Subjects initially performed submaximal exercise stress test (increasing 1 W every 2 s) on an electronically braked cycle ergometer to determine sub maximum heart rate.	about 12 weeks
lab investigations	lab investigation of Triglycerides (TG) mg/dl and c-reactive protein mg/l	about 14weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: zahra 63 serry, prof, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): December 5, 2018
• Study Completion (Actual): May 25, 2019

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (Actual): May 3, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 10, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: P.T.REC/012/001579

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No