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

NCT04882644 | Completed

• 1 other identifier: NMU20212022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Lean NAFLD

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in the liver fat content at 3 months after intervention.

  The magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) is used to detect the liver content. An diagnosis of NAFLD is the liver fat content \> 5%. Changes = (liver fat content at 3 months after intervention - liver fat content at baseline)

  3 months

Secondary Outcomes (12)

• Changes from baseline in body mass index (BMI) at 3/12 months after intervention.

  3 months, 12 months

• Changes from baseline in waist hip ratio(WHR) at 3/12 months after intervention.

  3 months, 12 months

• Changes from baseline in abdominal fat at 3/12 months after intervention.

  3 months, 12 months

• Changes from baseline in blood pressure at 3/12 months after intervention.

  3 months, 12 months

• Changes from baseline in triglycerides at 3/12 months after intervention.

  3 months, 12 months

Study Arms (2)

Aerobic Exercise Intervention Group

EXPERIMENTAL

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

Behavioral: Aerobic Exercise

Control Group

NO INTERVENTION

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

Interventions

Aerobic Exercise 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.

Aerobic Exercise Intervention Group

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Subjects with NAFLD determined by MRI-PDFF (liver fat\>5%).
• \. Subjects with BMI\<23 kg/m2.
• \. Subjects with inactive exercise before.
• \. Subjects with basic abilities of understanding, communication and writing.

You may not qualify if:

• \. 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).
• \. Complicated with other liver diseases (i.e. acute or chronic viral hepatitis, liver cancer, liver cirrhosis, drug-induced liver diseases, and autoimmune hepatitis).
• \. Subjects with abnormal liver function (i.e. more than 3 times the upper limit of normal alanine aminotransferase and aspartate aminotransferase).
• \. Complicated with severe cardiovascular disease \[i.e. myocardial infarction, arrhythmia, heart failure (New York Heart Association III or IV), uncontrolled hypertension (i.e. systolic blood pressure \>180 mmHg, and/or diastolic blood pressure \>100 mmHg)\].
• \. Complicated with severe kidney disease or severe renal insufficiency or tumour.
• \. Currently pregnant or planning to be pregnant or breast feeding women.
• \. Participating in weight loss programs/exercise programs currently or during the past three months.
• \. Having any medical condition that would affect metabolism or limit exercise (i.e. diabetes, known hyperthyroidism or hypothyroidism).
• \. 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).
• \. Having been doing regular physical exercise for the past three months (i.e. 3 times/week, \>30 min/time).
• \. Subjects with poor adherence.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Nanjing Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, China, 210029, China

Location

Related Publications (4)

• Lee S, Bacha F, Hannon T, Kuk JL, Boesch C, Arslanian S. Effects of aerobic versus resistance exercise without caloric restriction on abdominal fat, intrahepatic lipid, and insulin sensitivity in obese adolescent boys: a randomized, controlled trial. Diabetes. 2012 Nov;61(11):2787-95. doi: 10.2337/db12-0214. Epub 2012 Jun 29.

  PMID: 22751691 BACKGROUND

• Zhang HJ, He J, Pan LL, Ma ZM, Han CK, Chen CS, Chen Z, Han HW, Chen S, Sun Q, Zhang JF, Li ZB, Yang SY, Li XJ, Li XY. Effects of Moderate and Vigorous Exercise on Nonalcoholic Fatty Liver Disease: A Randomized Clinical Trial. JAMA Intern Med. 2016 Aug 1;176(8):1074-82. doi: 10.1001/jamainternmed.2016.3202.

  PMID: 27379904 BACKGROUND

• Houghton D, Thoma C, Hallsworth K, Cassidy S, Hardy T, Burt AD, Tiniakos D, Hollingsworth KG, Taylor R, Day CP, McPherson S, Anstee QM, Trenell MI. Exercise Reduces Liver Lipids and Visceral Adiposity in Patients With Nonalcoholic Steatohepatitis in a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2017 Jan;15(1):96-102.e3. doi: 10.1016/j.cgh.2016.07.031. Epub 2016 Aug 10.

  PMID: 27521509 BACKGROUND

• Kistler KD, Brunt EM, Clark JM, Diehl AM, Sallis JF, Schwimmer JB; NASH CRN Research Group. Physical activity recommendations, exercise intensity, and histological severity of nonalcoholic fatty liver disease. Am J Gastroenterol. 2011 Mar;106(3):460-8; quiz 469. doi: 10.1038/ajg.2010.488. Epub 2011 Jan 4.

  PMID: 21206486 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Qun Zhang, Professor

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 12, 2021
• Study Start: May 14, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)