Menu
Not yet recruiting NCT07177963

CPET-based HIIT for MAFLD

No phase Interventional Metabolic Dysfunction-Associated Fatty Liver Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HIIT, No specific exercise intervention..
Who it may be relevant to
Registry conditions: Metabolic Dysfunction-Associated Fatty Liver Disease. Basic parameters: 35 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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
  • 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 traini

Primary outcome measures

  • Liver fat content (%) [Time frame: Baseline (week 0) , after complete post-training (week 8).]
Secondary outcome measures (12)
  • LSM (kPa) [Time frame: Baseline (week 0) , after complete post-training (week 8).]
  • Blood specimen [Time frame: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).]
  • Blood specimen [Time frame: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).]
  • Blood specimen [Time frame: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).]
  • Blood specimen [Time frame: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).]
  • Blood specimen [Time frame: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).]
  • Blood specimen [Time frame: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).]
  • Blood specimen [Time frame: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).]
  • Blood specimen [Time frame: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).]
  • Blood specimen [Time frame: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).]
  • Blood specimen [Time frame: After first time and complete of mid-training (week 4), after first time and complete of post-training (week 8).]
  • Exercise Feasibility [Time frame: Every week after complete training from week 1 to week 8.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 5 centers
  • Beijing Ditan Hospital, Capital Medical University — Beijing
  • Beijing Friendship Hospital, Capital Medical University — Beijing
  • Beijing Youan Hospital, Capital Medical University — Beijing
  • Peking University Third Hospital — Beijing
  • The Fifth Medical Center, Chinese PLA General Hospital — Beijing

Identifiers

NCT: NCT07177963 · CPHIT1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗