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

Nanjing Medical University

Status

Completed

Conditions

Non-alcoholic Fatty Liver Disease

Treatments

Behavioral: Aerobic Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT04882644

NMU20212022

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 patients

Sex

All

Ages

30 to 55 years old

Volunteers

No Healthy Volunteers

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.