Vigorous- Versus Moderate-intensity Exercise to Reduce Liver Fat in Adults With Obesity and NAFLD

NCT06124456 | Recruiting

• 1 other identifier: HKU-NFI
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

Non-alcoholic fatty liver disease (NAFLD) arising from obesity has become a global health concern. Although exercise is a cornerstone approach for managing NAFLD, detailed exercise prescription guidelines are unavailable. According to World Health Organization (WHO) recommendations, 1 minute of vigorous-intensity physical activity can achieve equivalent health benefits to 2 minutes of moderate-intensity physical activity. It is not known whether this relationship is applicable to exercise prescribed as an adjunct therapy in NAFLD treatment. The answer has public health implications because people living with NAFLD can potentially opt for safe higher-intensity exercise requiring less of a time commitment, whereas those in older age groups or with comorbidities, for whom vigorous exercise is unsuitable, can adopt a moderate-intensity regimen of longer duration to acquire equivalent therapeutic outcomes. Adults with obesity and NAFLD will be randomly allocated to a supervised vigorous- or moderate-intensity walking group or usual care control group. Each exercise group will receive a 16-week intervention comprising three walking sessions weekly, whereas the usual care group will receive general health education as the attention control. The per-session walking time will be 25 minutes for the vigorous group and 50 minutes for the moderate group, equating to the same weekly exercise volume and caloric expenditure for each group according to the WHO's minimum physical activity recommendation. Outcome measures, including liver fat, visceral and body fat, body anthropometry, intervention adherence, psychological measures, health-related quality of life, medication usage, adverse events, habitual physical activity, and diet, will be examined by assessors blinded to the group allocation at baseline, 16 weeks (post-intervention), and 42 weeks (26-week post-intervention follow-up). Data will be analyzed by generalized estimating equations and linear contrasts. The proposed study will provide evidence on the presumed equivalent benefits of vigorous- and moderate-intensity exercise, with a follow-up period allowing assessment of the efficacy, safety, adherence, and sustainability of each. The findings will inform practitioners of the role of exercise intensity in reducing liver fat and refine the exercise guidelines for NAFLD patients.

Conditions

Obesity; NAFLD

Keywords

NAFLD; Obesity; Liver Fat; exercise

Outcome Measures

Primary Outcomes (1)

• Liver Fat

  Intrahepatic triglycerides will be examined using 1H-MR spectroscopy in a 3×3×3 cm voxel using a 3.0T system. A trained MRI technician will operate the machine, position the subjects, and analyze the results.

  16 weeks

Secondary Outcomes (11)

• Liver Fat

  42 weeks

• Visceral Adiposity

  16 weeks, 42 weeks

• Body Adiposity

  16 weeks, 42 weeks

• Body Anthropometry-Height

  16 weeks, 42 weeks

• Body Anthropometry- Weight

  16 weeks, 42 weeks

Study Arms (3)

Usual Care Control Group

PLACEBO COMPARATOR

Other: Usual Care Control Group

Moderate-intensity Exercise Intervention

EXPERIMENTAL

Other: Moderate-intensity Exercise Intervention

Vigorous-intensity Exercise Intervention

EXPERIMENTAL

Other: Vigorous-intensity Exercise Intervention

Interventions

Usual Care Control Group OTHER

Subjects in the usual care control group will receive health education as the attention control. The program will consist of eight 150-minute bi-weekly sessions covering major health issues relating to general health and NAFLD, to be obtained from publicly accessible resources from the Hong Kong Department of Health. Health education information on non-communicable diseases (e.g., cancers, diabetes, coronary heart diseases, obesity, and mental illness), infectious diseases (e.g., COVID-19), and a healthy lifestyle (e.g., balanced diet, physical activity, good sleep, tobacco use, alcohol cessation, and stress management) will also be distributed to the subjects in the exercise groups through recorded presentation videos and leaflets/pamphlets during the first 16 weeks.

Usual Care Control Group

Moderate-intensity Exercise Intervention OTHER

The walking time in each session will be 50 minutes for the moderate-intensity group. The overall weekly exercise volume for the two groups will be the same based on total energy expenditure, as per the WHO's physical activity recommendation (150 minutes of moderate-intensity physical activity weekly is equivalent to 75 minutes of vigorous-intensity physical activity weekly). Five minutes of walking at a normal pace will be included for warm-up and cool-down.

Moderate-intensity Exercise Intervention

Vigorous-intensity Exercise Intervention OTHER

The walking time in each session will be 25 minutes for the vigorous-intensity group. The overall weekly exercise volume for the two groups will be the same based on total energy expenditure, as per the WHO's physical activity recommendation (150 minutes of moderate-intensity physical activity weekly is equivalent to 75 minutes of vigorous-intensity physical activity weekly). Five minutes of walking at a normal pace will be included for warm-up and cool-down.

Vigorous-intensity Exercise Intervention

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cantonese, Mandarin, or English-speaking Chinese,
• aged 18-69,
• centrally obese according to the Asia-specific cut-off (waist circumference 90 cm for males, 80 cm for females) and BMI ≥23 (i.e., overweight as defined by the Hong Kong government),
• with NAFLD (defined as \>5% intrahepatic triglycerides assessed by 1H-MR spectroscopy),
• able to perform the prescribed exercise program. Both men and women will be included to enhance generalizability.

You may not qualify if:

• regular exercise training (\>3 sessions of \>60 min of moderate-intensity exercise training weekly) in the past 6 months,
• medical history of cardiovascular disease, chronic pulmonary or kidney disease, heart failure, cancer, and/or liver disease except NAFLD,
• somatic conditions that limit exercise participation (e.g., limb loss),
• impaired mobility due to chronic disease (e.g., chronic arthritis/osteoarthritis, neurological, musculoskeletal, and autoimmune diseases),
• daily smoking habit,
• excess alcohol consumption (daily ≥20 g of alcohol for men and ≥10 g for women) in the past 1 year,
• consumption of certain drugs (e.g., tamoxifen and estrogen) known to be secondary causes of steatosis,
• surgery and therapy for morbid obesity in the past 6 months and during the study period (e.g., gastric bypass, gastric band, sleeve gastrectomy, gastric reduction duodenal switch, or dietitian-prescribed dietary program).

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

LKS Faculty of Medicine

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Obesity; Non-alcoholic Fatty Liver Disease; Fatty Liver; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Behavior

Study Officials

• Parco M Siu, PhD

  LKS Faculty of Medicine, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Parco M Siu, PhD

CONTACT

28315262; pmsiu@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Random allocation will be performed after subjects have completed the baseline assessments. Subjects and the research personnel delivering the walking program and health education cannot be blinded to group allocation, but the latter will not be involved in the outcome assessments. All personnel involved in the outcome assessments will be blinded to the group allocation, and subjects will be instructed not to disclose their allocation during the assessments. The research personnel conducting the statistical analysis cannot be fully blinded to the treatment allocation for the between-group comparisons but will be blinded to subjects' identity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Division Head

Model Details: Subjects will be randomly allocated to the usual care control or moderate- or vigorous-intensity walking groups on a 1:1:1 basis using block randomization with a block size between 6 and 12. Randomization will be implemented by the biostatistician Co-I or his delegate, who will not interact with the subjects or research personnel during recruitment to avoid allocation bias. The research personnel will then obtain the sequence for each subject to ensure allocation concealment.

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 9, 2023
• Study Start: May 23, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 3 years following the publication of the article.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Proposals should be directed to pmsiu@hku.hk to gain access and for data request, a data-access agreement needs to be signed.

Locations

HK (1)