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

NCT03936803 | Completed

• 1 other identifier: P.T.REC/012/001579
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

exercise group

ACTIVE COMPARATOR

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 .

electro-acupuncture group

ACTIVE COMPARATOR

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

Interventions

aerobic interval training exercise . BEHAVIORAL

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

exercise group

electro acupuncture DEVICE

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

electro-acupuncture group

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of physical therapy Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• zahra 63 serry, prof

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 3, 2019
• Study Start: May 1, 2017
• Primary Completion: December 5, 2018
• Study Completion: May 25, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

EG (1)