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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change in Liver Fat
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cantonese, Mandarin, or English speaking Chinese;
- •Aged 18-69;
- •Male or female;
- •Centrally obese according to the Asian-specific cut-off (waist circumference ≥90 cm for males; ≥80 cm for females) and with BMI ≥23;
- •With NAFLD (defined as >5% intrahepatic triglycerides assessed by 1H-MRS);
- •Willing to participate in exercise training to improve NAFLD.
排除标准
- •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, therapy, or medication for obesity or weight loss in the past 6 months (e.g., gastric bypass, gastric band, sleeve gastrectomy, gastric reduction duodenal switch, or dietitian-prescribed dietary program);
- •Physical changes that considerably affect body composition and weight (e.g., anorexia nervosa, bulimia nervosa, prolonged gastrointestinal and digestive disorders) during the study period.
研究组 & 干预措施
Once-a-week Exercise
Once-a-week vigorous-intensity exercise for 4 months.
干预措施: Once-a-week Exercise (Behavioral)
Thrice-a-week Exercise
Thrice-a-week vigorous-intensity exercise for 4 months.
干预措施: Thrice-a-week Exercise (Behavioral)
Usual Care Control
Bi-weekly health education for 4 months.
干预措施: Usual Care Control (Other)
结局指标
主要结局
Change in Liver Fat
时间窗: 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.
次要结局
- Change in Abdominal Visceral Fat(Baseline, 4 months (post-intervention), and 10 months (follow-up))
- Change in Body Mass Index(Baseline, 4 months (post-intervention), and 10 months (follow-up))
- Change in Maximal Oxygen Consumption(Baseline, 4 months (post-intervention), and 10 months (follow-up))
- Number of Adverse Events(Baseline, 4 months (post-intervention), and 10 months (follow-up))
- Change in Liver Fat(Baseline and 10 months (follow-up))
- Change in Body Fat(Baseline, 4 months (post-intervention), and 10 months (follow-up))
- Change in Mental Component Summary Score of the 12-Item Short-Form Health Survey(Baseline, 4 months (post-intervention), and 10 months (follow-up))
- Change in Waist Circumference(Baseline, 4 months (post-intervention), and 10 months (follow-up))
- Change in Physical Component Summary Score of the 12-Item Short-Form Health Survey(Baseline, 4 months (post-intervention), and 10 months (follow-up))
研究者
Parco M. Siu, PhD
Associate Professor and Division Head
The University of Hong Kong