CPET-based HIIT for MAFLD

NCT07177963 | Not Yet Recruiting

• 1 other identifier: CPHIT1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 5

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.

Conditions

Metabolic Dysfunction-Associated Fatty Liver Disease

Keywords

CPET; Exercise; HITT; Peak VO2; MAFLD

Outcome Measures

Primary Outcomes (1)

• Liver fat content (%)

  Liver fat content will be measured using MRI-PDFF.

  Baseline (week 0) , after complete post-training (week 8).

Secondary Outcomes (17)

• LSM (kPa)

  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).

• Blood specimen

  Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).

• Blood specimen

  Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).

• Blood specimen

  Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).

Study Arms (2)

HIIT group

EXPERIMENTAL

Home-based HIIT performed on electric resistance bikes.

Behavioral: HIIT

Control Group

OTHER

No specific exercise intervention.

Behavioral: No specific exercise intervention.

Interventions

HIIT BEHAVIORAL

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.

HIIT group

No specific exercise intervention. BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tang Yida: lead

Study Sites (5)

Beijing Ditan Hospital, Capital Medical University

Beijing, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Location

Beijing Youan Hospital, Capital Medical University

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

The Fifth Medical Center, Chinese PLA General Hospital

Beijing, China

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Yida Tang

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

Yida Tang, MD,PhD

CONTACT

010-82265996; tangyida@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: 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;

Model Details: 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.

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 17, 2025
• Study Start: September 8, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)