CPET-based HIIT for MAFLD

NCT07177963 · tracked via the Priya Life Science China tracker

Sponsor

Tang Yida

Phase

Not applicable

Started

2025-09-08

Last updated

2025-09-17

Condition(s) studied

Metabolic Dysfunction-Associated Fatty Liver Disease

Investigational drug(s) / intervention(s)

HIITNo specific exercise intervention.

HIIT: 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.

No 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.

Study 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.

Eligibility

Sex

ALL

Min age

35 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

Liver fat content (%) — Baseline (week 0) , after complete post-training (week 8).
Liver fat content will be measured using MRI-PDFF.

Trial sites (5)

Facility	City	Region
Beijing Ditan Hospital, Capital Medical University	Beijing	China
Beijing Friendship Hospital, Capital Medical University	Beijing	China
Beijing Youan Hospital, Capital Medical University	Beijing	China
Peking University Third Hospital	Beijing	China
The Fifth Medical Center, Chinese PLA General Hospital	Beijing	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07177963 on ClinicalTrials.gov ↗ ← All trials in China