Effects of Aerobic Exercise on Lean Non-alcoholic Fatty Liver Disease (NAFLD)

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-14

Study Completion Date

2022-09-30

Brief Summary

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NAFLD is increasingly being identified in lean individuals, especially in Chinese population. Among the NAFLD patients, the lean NAFLD accounts for 15.9%-23.0%. Previous studies showed that the lean NAFLD individuals might have a higher risk of severe hepatic disease than those obese individuals. However, the effects of aerobic exercise on the reduction of liver fat content and metabolic risk factors in lean NAFLD individuals remain unknown. In this randomized controlled trial, we will examine the effect of a 3-month exercise training (aerobic exercise) on liver fat content and metabolic risk factors in lean NAFLD individuals.

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Detailed Description

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The whole study is divided into four phases: recruitment phase, training phase (1 month, aim to gradually adapt patients to the target exercise intensity), implementation phase (3 months), and follow-up phase (9 months). And the subjects are randomly assigned to two groups: aerobic exercise intervention group and control group.

Conditions

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Non-alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aerobic Exercise Intervention Group

The subjects receive an intensive aerobic exercise for 3 months and a health education content for 12 months.

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type BEHAVIORAL

The subjects conduct an aerobic exercise at 65-80% maximum oxygen consumption three times per week for 60 min/session (including 5 min warm-up and 5 min cool down) with treadmills, ellipticals, and rowing machine. The subjects attend health education sessions (eg, general health knowledge of NAFLD and metabolic diseases, and elements of a healthy lifestyle) monthly in the 12 months.

Control Group

The subjects do not change their physical activity routine and receive a health education content for 12 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aerobic Exercise

The subjects conduct an aerobic exercise at 65-80% maximum oxygen consumption three times per week for 60 min/session (including 5 min warm-up and 5 min cool down) with treadmills, ellipticals, and rowing machine. The subjects attend health education sessions (eg, general health knowledge of NAFLD and metabolic diseases, and elements of a healthy lifestyle) monthly in the 12 months.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 1\. Subjects with NAFLD determined by MRI-PDFF (liver fat\&gt;5%).

2\. Subjects with BMI\&lt;23 kg/m2.

3\. Subjects with inactive exercise before.

4\. Subjects with basic abilities of understanding, communication and writing.

Exclusion Criteria

* 1\. Regular drinkers (consumed more than an average of 140 grams of ethanol per week in men and 70 grams in women during the past twelve months).

2\. Complicated with other liver diseases (i.e. acute or chronic viral hepatitis, liver cancer, liver cirrhosis, drug-induced liver diseases, and autoimmune hepatitis).

3\. Subjects with abnormal liver function (i.e. more than 3 times the upper limit of normal alanine aminotransferase and aspartate aminotransferase).

4\. Complicated with severe cardiovascular disease \[i.e. myocardial infarction, arrhythmia, heart failure (New York Heart Association III or IV), uncontrolled hypertension (i.e. systolic blood pressure \&gt;180 mmHg, and/or diastolic blood pressure \&gt;100 mmHg)\].

5\. Complicated with severe kidney disease or severe renal insufficiency or tumour.

6\. Currently pregnant or planning to be pregnant or breast feeding women.

7\. Participating in weight loss programs/exercise programs currently or during the past three months.

8\. Having any medical condition that would affect metabolism or limit exercise (i.e. diabetes, known hyperthyroidism or hypothyroidism).

9\. Having a medical condition that would limit exercise participation or alter heart rate during exercise or taking medication that would affect metabolism or weight loss (i.e. glucocorticoids, antithyroid drugs, hypoglycemic drugs, antihypertensive drugs).

10\. Having been doing regular physical exercise for the past three months (i.e. 3 times/week, \&gt;30 min/time).

11\. Subjects with poor adherence.

Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No