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Completed

NCT Number: NCT03936803

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

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of physical therapy Cairo university

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

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

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 3, 2019
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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