Metabolic Dysfunction-Associated Fatty Liver Disease
Conditions
Keywords
CPET, Exercise, HITT, Peak VO2, MAFLD
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALHIIT
Exercise sessions were conducted as telemedically supervised, home-based HIIT performed on electric resistance bikes, with protocols individually tailored. Each HIIT session comprised 8 cycles of alternating 30-second high-intensity intervals (HIT at 80% peakVO₂) and 60-second low-intensity recovery intervals (LIT at 50% peakVO₂). Warm-up and cool-down phases were performed with the bike's resistance set to 0 watts (unloaded pedaling). The total intervention duration was 8 weeks. Received health lifestyle education based on the Prevention and Treatment Guidelines for Metabolic (Non-Alcoholic) Fatty Liver Disease (2024 Edition) and the Dietary Guidelines for Adults with Hyperlipidemia (2023 Edition).Wear smart bracelets 24/7 to monitor daily activity levels, with participants prohibited from engaging in any other systematic exercise training during the intervention period.
BEHAVIORALNo specific exercise intervention.
The control group will not receive any exercise intervention, and they will be instructed to not take any structured exercise regimens.Received health lifestyle education based on the Prevention and Treatment Guidelines for Metabolic (Non-Alcoholic) Fatty Liver Disease (2024 Edition) and the Dietary Guidelines for Adults with Hyperlipidemia (2023 Edition).Wear smart bracelets 24/7 to monitor daily activity levels, with participants prohibited from engaging in any other systematic exercise training during the intervention period.
Sponsors
Tang Yida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver fat content (%) | Baseline (week 0) , after complete post-training (week 8). | Liver fat content will be measured using MRI-PDFF. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood specimen | Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8). | Lab tests include red blood cell count. |
| Exercise Feasibility | Every week after complete training from week 1 to week 8. | The implementation status of the home-based exercise prescription, including training frequency per week, average pedal frequency of the high-intensity exercise on the resistance bike, and average pedal frequency of the low-intensity exercise on the resistance bike |
| LSM (kPa) | Baseline (week 0) , after complete post-training (week 8). | Liver fibrosis will be measured using MRE. |
| BMI | Baseline (week 0) , after complete post-training (week 8). | Weight (kg) is measured with digital weighing scale. Height (cm) is measured with a portable stadiometer. BMI is calculated as weight in kilograms divided by the square of height in meters |
| Brog score | After complete mid-training (week 4) , after complete post-training (week 8). | The Borg Subjective Fatigue Scale (Borg) would be tested after each session |
| Peak VO2 | Baseline (week 0) , after complete post-training (week 8). | Peak VO2 is assessed through CPET, using a maximal graded treadmill test based on the Chinese expert consensus on the standardized clinical application of CPET. |
Countries
China
Contacts
Primary ContactYida Tang, MD,PhD
Outcome results
None listed