Effects of Exercise on Patients With Nonalcoholic Fatty Liver Disease- A Comparative Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-09

Study Completion Date

2018-12-10

Brief Summary

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background: Obesity, diabetes mellitus type II and fatty liver disease combining with low levels of physical activity are prominent health risks for mortality and morbidity. More than 1/3 of the current population is suffering from obesity with a significant proportion to medical complications which can negatively influence their quality of life. These complications comprise alterations of the metabolism of glucose and fat, insulin resistance and diabetes mellitus. Objectives The purpose of this study was to compare between high intensity interval exercise and moderate intensity continuous on diabetic obese patients with NAFLD. Methods: forty-seven diabetic obese individuals with NAFLD were enrolled in this study. The individuals were randomly divided into 16 in HII group, 15 in MIC group, and 16 in the controls. HII group received HII exercise, MIC group received 8-week MIC exercise while the control group did not receive any exercise intervention. IHTG and visceral lipids were assessed pre- and post-intervention.

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Detailed Description

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This randomized controlled trial initially included 48 diabetic obese patients with NAFLD, their age was 40 to 60 years and divide them equally into three groups. The data went to the analysis were 47 due to drop out of one subject. The 47 patients were randomly classified into 3 groups. Group I included 16 patients, received medical treatment with a program of HII exercise 3 times/wk for 8 weeks (HII group), group II included 15 patients, received moderate-intensity continuous (MIC) exercise 3 times/wk for 8 weeks (MIC group), and group III included 16 patients, received only medical treatment without exercise program (control).

Inclusion criteria: All patients were diagnosed with NAFLD, type II DM, and obesity (body mass index \[BMI\] ≥30 kg/m2). The diagnostic criteria of NAFLD based on the diagnostic guidelines for NAFLD in the Asia-Pacific region.\[29\] All study participants were non-smokers.

Exclusion criteria: Any patient had a severe life limiting illness (cancer, renal failure), uncontrolled heart disease, neuromuscular limitations, orthopedic problems, and endocrine disorders that could affect physical exercise was excluded from the study.

The HII exercise program was performed on a cycle Ergometer with firmly grasping the rails to maintain balance. The exercise session was started with a 5 minute warm up involving cycling exercise without resistance of the Ergometer followed by three sets of 4-min cycling sessions at 80-85% of the VO2max with 2-min interval at 50% of the VO2max between sets. The session was finished with 5 minutes of cool down exercise.

MIC group, each patient was received (MIC 3 times/week) for eight weeks, according to following parameters; 5 minutes warm up, followed by 30 minutes of continuous aerobic exercise on a cycle Ergometer with constant intensity at 70 to 75% of peak HR and 5 minutes cool down. Also, these measures were obtained at the beginning and the end of the intervention.

Conditions

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Diabetes Nonalcoholic Fatty Liver Disease Obesity Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

HII group, each patient in this group were conducted a program of high-intensity aerobic exercise for 8 weeks, three times per week with each exercise session lasting for nearly 40 minutes morning. Each patient was instructed to not eat for 2 hours before the exercise session to avoid exercise induced airway obstruction. MIC group, each patient was received (MIC 3 times/week) for eight weeks, according to following parameters; 5 minutes warm up, followed by 30 minutes of continuous aerobic exercise on a cycle Ergometer with constant intensity at 70 to 75% of peak HR and 5 minutes cool down. Also, these measures were obtained at the beginning and the end of the intervention.

Control group only received medical treatment with no exercise intervention

Study Groups

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Study group 1

High Intensity Interval Excercise

Group Type ACTIVE_COMPARATOR

High-Intensity Interval Exercise & Moderate Intensity Interval Exercise

Intervention Type OTHER

Different Interval intensities Exercise

Study group 2

Moderate Intensity Interval Exercise

Group Type ACTIVE_COMPARATOR

High-Intensity Interval Exercise & Moderate Intensity Interval Exercise

Intervention Type OTHER

Different Interval intensities Exercise

Control group

No Intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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High-Intensity Interval Exercise & Moderate Intensity Interval Exercise

Different Interval intensities Exercise

Intervention Type OTHER

Other Intervention Names

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Exercise

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of NAFLD, type II DM, and obesity.
* Body mass index (BMI) ≥30 kg/m2.
* Age: 40-60 years
* No smoking.

Exclusion Criteria

* Severe life limiting illness (cancer, renal failure),
* Uncontrolled heart disease,
* Neuromuscular limitations,
* Orthopedic problems
* Endocrine disorders that could affect physical exercise

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No