CPET-based HIIT for MAFLD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-65
SponsorTang Yida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
HIIT
BehavioralExercise 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.
No specific exercise intervention.
BehavioralThe 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.
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: HIIT groupExperimental treatment 1 intervention
Group B: Control GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
Liver fat content (%)
Liver fat content will be measured using MRI-PDFF.
Time frame
Baseline (week 0) , after complete post-training (week 8).Secondary outcomes
1
LSM (kPa)
Liver fibrosis will be measured using MRE.
Time frame
Baseline (week 0) , after complete post-training (week 8).2
Blood specimen
Lab tests include red blood cell count.
Time frame
Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).3
Blood specimen
Lab tests include hematocrit.
Time frame
Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).4
Blood specimen
Lab tests include hemoglobin count.
Time frame
Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tang Yida
Lead sponsor
Peking University Third Hospital
Sponsor institution
Source ClinicalTrials.gov
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