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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIIT group | Experimental | Home-based HIIT performed on electric resistance bikes. |
|
| Control Group | Other | No specific exercise intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Liver fat content (%) | Liver fat content will be measured using MRI-PDFF. | Baseline (week 0) , after complete post-training (week 8). |
| Measure | Description | Time Frame |
|---|---|---|
| LSM (kPa) | Liver fibrosis will be measured using MRE. | Baseline (week 0) , after complete post-training (week 8). |
| Blood specimen | Lab tests include red blood cell count. |
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Inclusion Criteria:
Adults age 35~65 years Nonalcoholic fatty liver diagnosed by abdominal ultrasonography
In conjunction with at least one cardiometabolic risk factor:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yida Tang, MD,PhD | Contact | 010-82265996 | tangyida@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yida Tang | Peking University Third Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University | Beijing | China | ||||
| Beijing Friendship Hospital, Capital Medical University |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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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.
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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.
|
| 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. |
|
| Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8). |
| Blood specimen | Lab tests include hematocrit. | Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8). |
| Blood specimen | Lab tests include hemoglobin count. | Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8). |
| Blood specimen | Lab tests include testosterone. | Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8). |
| Blood specimen | Lab tests include cortisol. | Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8). |
| Blood specimen | Lab tests include creatine kinase. | Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8). |
| Blood specimen | Lab tests include blood urea. | Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8). |
| Blood specimen | Lab tests include alanine aminotransferase. | Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8). |
| Blood specimen | Lab tests include aspartate aminotransferase. | Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8). |
| Blood specimen | Lab tests include lactic acid | After first time and complete of mid-training (week 4), after first time and complete of post-training (week 8). |
| Exercise Feasibility | 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 | Every week after complete training from week 1 to week 8. |
| LSM (kPa) | Liver fibrosis will be measured using Fibrotouch@. | Baseline (week 0) , after complete post-training (week 8). |
| Peak VO2 | 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. | Baseline (week 0) , after complete post-training (week 8). |
| BMI | 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 | Baseline (week 0) , after complete post-training (week 8). |
| Brog score | The Borg Subjective Fatigue Scale (Borg) would be tested after each session | After complete mid-training (week 4) , after complete post-training (week 8). |
| Exercise Feasibility | The proportion of subjects leaving group during the preparation period and early termination of the trial | From baseline (week 0) to after complete post-training (week 8). |
| 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 |