LKS Faculty of Medicine
Hong Kong
NCT Number: NCT05741957
This study aims to examine the comparative effectiveness of different exercise frequencies (once-a-week vs. thrice-a-week) for reducing liver fat in centrally obese adults with non-alcoholic fatty liver disease (NAFLD), with weekly exercise volumes aligned with the World Health Organization's physical activity recommendations.
This study is active but is not currently recruiting participants.
Notify Me18 year–69 year
All sexes
Interventional
Not applicable
Hong Kong
This study is a three-arm randomized controlled trial. Participants will be randomly allocated to the once-a-week exercise group, thrice-a-week exercise group, or usual care control group. The exercise intervention groups will receive once-a-week or thrice-a-week exercise (with matched weekly exercise volumes). The usual care control group will receive general health education. All interventions will last for 4 months. Outcome measures will be examined at baseline, 4 months (post-intervention), and 10 months (6-month follow-up).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in this group will participate in a supervised treadmill exercise program delivered by certified fitness instructors. The prescribed program will involve one session weekly for 4 months, and the duration of vigorous-intensity treadmill exercise per session will be 75 min. Participants will exercise with an exercising heart rate at 6-7 metabolic equivalents (METs). Health information provided to the usual care control group will be made available to the participants in this group.
Participants in this group will participate in a supervised treadmill exercise program delivered by certified fitness instructors. The prescribed program will involve three sessions weekly for 4 months, and the duration of vigorous-intensity treadmill exercise per session will be 25 min. Participants will exercise with an exercising heart rate at 6-7 METs. Health information provided to the usual care control group will be made available to the participants in this group.
Participants in this group will receive health education delivered by research personnel. This program will consist of eight two-hour bi-weekly sessions covering major health issues relating to general health and NAFLD, such as non-communicable diseases, infectious diseases, and a healthy lifestyle.
Time frame: Baseline and 4 months (post-intervention)
Intrahepatic triglycerides will be assessed using proton magnetic resonance spectroscopy (1H-MRS) in a 3×3×3 cm voxel.
Time frame: Baseline and 10 months (follow-up)
Intrahepatic triglycerides will be assessed using 1H-MRS in a 3×3×3 cm voxel.
Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Abdominal visceral fat will be assessed using magnetic resonance imaging (MRI).
Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Total body fat mass will be assessed using dual-energy x-ray absorptiometry (DXA).
Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Weight and height will be assessed using a calibrated electronic digital weighing scale and a stadiometer, respectively.
Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Waist circumference will be assessed using an inelastic measuring tape to the nearest 0.1 cm on bare skin.
Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Maximal oxygen consumption will be assessed using the modified Bruce protocol.
Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Physical health-related quality of life will be assessed using the Physical Component Summary scale of the 12-Item Short-Form Health Survey (SF-12). Scores on the scale range from 0 to 100, with higher scores indicating better physical health-related quality of life.
Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Mental health-related quality of life will be assessed using the Mental Component Summary scale of the 12-Item Short-Form Health Survey (SF-12). Scores on the scale range from 0 to 100, with higher scores indicating better mental health-related quality of life.
Time frame: Baseline, 4 months (post-intervention), and 10 months (follow-up)
Adverse events related or unrelated to the intervention will be assessed.
The University of Hong Kong
Other
Examining the Optimal Exercise Frequency for Alleviating Liver Fat in Centrally Obese Adults With Non-Alcoholic Fatty Liver Disease (NAFLD): A Comparative Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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