NCT07177963

CPET-based HIIT for MAFLD

Cardiopulmonary Exercise Testing-based High-intensity Interval Training For Improving MAFLD

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Tang Yida · Academic / Other
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolic Dysfunction-Associated Fatty Liver Disease

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2025-09-08
• Primary completion: 2026-03-31
• Completion: 2026-04-30
• First posted: 2025-09-17
• Last updated: 2025-09-17

Locations

5 sites across 1 country: China