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NCT Number: NCT07177963

CPET-based HIIT for MAFLD

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.

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Ditan Hospital, Capital Medical University, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Liver fat content (%)

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

    Liver fat content will be measured using MRI-PDFF.

Secondary outcomes

  1. LSM (kPa)

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

    Liver fibrosis will be measured using MRE.

  2. Blood specimen

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

    Lab tests include red blood cell count.

  3. Blood specimen

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

    Lab tests include hematocrit.

  4. Blood specimen

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

    Lab tests include hemoglobin count.

  5. Blood specimen

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

    Lab tests include testosterone.

  6. Blood specimen

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

    Lab tests include cortisol.

  7. Blood specimen

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

    Lab tests include creatine kinase.

  8. Blood specimen

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

    Lab tests include blood urea.

  9. Blood specimen

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

    Lab tests include alanine aminotransferase.

  10. Blood specimen

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

    Lab tests include aspartate aminotransferase.

  11. Blood specimen

    Time frame: After first time and complete of mid-training (week 4), after first time and complete of post-training (week 8).

    Lab tests include lactic acid

  12. Exercise Feasibility

    Time frame: 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

  13. LSM (kPa)

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

    Liver fibrosis will be measured using Fibrotouch@.

  14. Peak VO2

    Time frame: 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.

  15. BMI

    Time frame: 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

  16. Brog score

    Time frame: After complete mid-training (week 4) , after complete post-training (week 8).

    The Borg Subjective Fatigue Scale (Borg) would be tested after each session

  17. Exercise Feasibility

    Time frame: From baseline (week 0) to after complete post-training (week 8).

    The proportion of subjects leaving group during the preparation period and early termination of the trial

Study contacts

Contact information is provided by the study sponsor or research team.

Yida Tang, MD,PhD

CONTACT

[email protected]

010-82265996

Sponsors and collaborators

Lead sponsor

Tang Yida

Other

Registry information

Official study title

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

Acronym: CEPHIT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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