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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03936803

Recruitment Status Completed

First Posted May 3, 2019

Last update posted November 13, 2019

Study Description

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

  • Condition or Disease:Non-Alcoholic Fatty Liver Disease
  • Intervention/Treatment: Behavioral: aerobic interval training exercise .
    Device: electro acupuncture
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Actual Enrollment: 50 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment
  • Official Title: Interval Training Versus Electro Acupuncture on Liver Functions in Patients With Non-alcoholic Fatty Liver Disease
  • Actual Study Start Date: May 2017
  • Actual Primary Completion Date: December 2018
  • Actual Study Completion Date: May 2019
Arms and interventions
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
Outcome Measures
  • Primary Outcome Measures: 1. body mass index [ Time Frame: about 4 weeks ]
    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
  • 2. lab investigations [ Time Frame: about 12 weeks ]
    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.
  • 3. lab investigations [ Time Frame: about 14weeks ]
    lab investigation of Triglycerides (TG) mg/dl and c-reactive protein mg/l
Eligibility Criteria
  • Ages Eligible for Study: 30 to 55 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts
Locations

Egypt
faculty of physical therapy Cairo university
Cairo

Sponsors and Collaborators

Cairo University

Investigators

Study Director: zahra 63 serry, prof Cairo University

More Information
  • Responsible Party: Cairo University
  • ClinicalTrials.gov Identifier: NCT03936803 History of Changes
  • Other Study ID Numbers: P.T.REC/012/001579
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: November 13, 2019
  • Last Verified: November 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Liver Diseases
    Fatty Liver
    Non-alcoholic Fatty Liver Disease