Cardiopulmonary Exercise Testing-based High-intensity Interval Training For Improving MAFLD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 6
- 主要终点
- Liver fat content (%)
研究概览
简要总结
High-intensity interval training (HIIT), as an individualized exercise training mode based on cardiopulmonary exercise testing (CPET), is characterized by high-intensity training sessions interspersed with short rest periods. The findings from recent trials suggest that in the management of metabolic dysfunction-associated fatty liver disease (MAFLD), compared with traditional aerobic exercise modes such as moderate-intensity continuous training, HIIT may achieve similar or even better effects in reducing liver fat content, increasing peak oxygen uptake, improving insulin resistance, and lowering blood pressure, despite requiring less time commitment and lower energy expenditure. However, there is currently no consensus regarding the formulation of HIIT exercise protocols.
Based on the lower limits of the current mainstream HIIT intensity, sets, and interval time parameters, this study aims to assess the effectiveness, safety, and feasibility of the current exercise prescription in improving MAFLD.
详细描述
54 Participants aged 35-65 years with MAFLD will be randomized 1:1 to intervention or control. The intervention group will undertake home-based HIIT four times weekly for 8 weeks. Each session comprises 8 cycles with 30-second bouts at 80% peak VO₂ followed by 60-second recoveries at 50% peak VO₂. The control group do not take any types of exercise interventions. Standard care would be provided for both groups.
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)
盲法说明
Only blinding is maintained for data management personnel, laboratory testing personnel, and data analysts, while not applied to subjects and clinical investigators in the clinical trial.
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 35~65 years Nonalcoholic fatty liver diagnosed by abdominal ultrasonography
- •In conjunction with at least one cardiometabolic risk factor:
- •Overweight or Obesity: ≥ 24kg/m2，or waist circumference ≥ 90 cm in men and > 85 cm in women, or excessive body fat mass
- •Prediabetes or type 2 diabetes mellitus: HbA1c ≥ 5.7%, or fasting plasma glucose ≥ 6.1mmol/L, or 2-h plasma glucose during OGTT ≥ 7.8mmol/L
- •Plasma triglycerides ≥ 1.7 mmol/L (>-150 mg/dl) or lipid-lowering treatment
- •HDL-cholesterol ≤ -1.0 mmol/L in men and ≤ -1.3 mmol/L in women or lipid-lowering treatment
- •Blood pressure ≥ 130/85 mmHg or treatment for hypertension
排除标准
- •Contraindications for Cardiopulmonary Exercise Testing
- •The electrocardiogram (ECG) results during cardiopulmonary exercise testing (CPET) showed positive findings
- •Receiving GLP-1 receptor agonists, SGLT-2i, or taking >2 antihypertensive/hypoglycemic/lipid-lowering/ antiarrhythmic drugs
- •Taking dietary supplements (e.g., fish oil products, over-the-counter diet pills, meal replacements)
- •Mental illness
- •Other liver diseases
- •Movement disorder related diseases and lower limb motor injury in the past 6 months
- •Pregnant, lactating or planning to become pregnant in the near future
研究组 & 干预措施
HIIT group
Home-based HIIT performed on electric resistance bikes.
干预措施: HIIT (Behavioral)
Control Group
No specific exercise intervention.
干预措施: No specific exercise intervention. (Behavioral)
结局指标
主要结局
Liver fat content (%)
时间窗: Baseline (week 0) , after complete post-training (week 8).
Liver fat content will be measured using MRI-PDFF.
次要结局
- Blood specimen(After first time and complete of mid-training (week 4), after first time and complete of post-training (week 8).)
- Exercise Feasibility(From baseline (week 0) to after complete post-training (week 8).)
- Peak VO2(Baseline (week 0) , after complete post-training (week 8).)
- BMI(Baseline (week 0) , after complete post-training (week 8).)
- Brog score(After complete mid-training (week 4) , after complete post-training (week 8).)
- LSM (kPa)(Baseline (week 0) , after complete post-training (week 8).)
- Brog score(After complete mid-training (week 4) , after complete post-training (week 8).)
- Exercise Feasibility(From baseline (week 0) to after complete post-training (week 8).)
- Peak VO2(Baseline (week 0) , after complete post-training (week 8).)
- Blood specimen(After first time and complete of mid-training (week 4), after first time and complete of post-training (week 8).)
- BMI(Baseline (week 0) , after complete post-training (week 8).)
- Blood specimen(Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).)
- Exercise Feasibility(Every week after complete training from week 1 to week 8.)
研究者
Tang Yida
Professor, Vice President of Peking University Third Hospital; Director of Institute of Vascular Medicine, Peking University Third Hospital; Deputy Director, State Key Laboratory of Vascular Homeostasis and Remodeling;
Peking University Third Hospital