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

NCT ID: NCT03936803

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2019-05-25

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

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

Conditions

Non-Alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

aerobic interval training exercise .

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

electro acupuncture

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ramy Salama Atia Draz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

zahra 63 serry, prof

Role: STUDY_DIRECTOR

Cairo University

Locations

faculty of physical therapy Cairo university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/001579

Identifier Type: -

Identifier Source: org_study_id