High-intensity interval training versus moderate-intensity continuous training for cardiometabolic health in adults with metabolic syndrome

ISRCTN ISRCTN18045412
DOI https://doi.org/10.1186/ISRCTN18045412
Submission date
19/07/2025
Registration date
23/07/2025
Last edited
23/07/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
This study aims to compare the effects of two types of exercise, High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MICT), on the health of middle-aged adults with metabolic syndrome. Metabolic syndrome includes conditions like high blood pressure, high blood sugar, abnormal cholesterol levels, and increased waist circumference, which raise the risk of heart disease and diabetes. The goal is to identify which type of exercise is more effective in improving health outcomes for people at risk of chronic diseases.

Who can participate?
Adults aged 40 to 60 years who have been diagnosed with metabolic syndrome

What does the study involve?
Participants will be randomly assigned to one of three groups: HIIT group, MICT group, or a control group that does not receive any specific exercise intervention. The exercise programs will last 12 weeks, with 3 sessions per week. The HIIT group will perform short bursts of intense exercise followed by rest periods, while the MICT group will perform moderate, steady-state exercises such as brisk walking or cycling. The researchers will measure various health markers before, during, and after the 12 weeks, including blood sugar, cholesterol, liver function, body weight, inflammation, and heart rate recovery.

What are the possible benefits and risks of participating?
All participants will receive professional supervision, and their safety will be closely monitored throughout the study. The findings may help develop better exercise programs for people with metabolic health issues.

Participants may experience temporary discomfort such as muscle soreness, fatigue, increased heart rate, or mild dizziness during training. All sessions are supervised by trained professionals. Emergency medical equipment (e.g., AED) is available at all training sites, and participants may withdraw from the study at any time without penalty. These risks are minimal and well-managed.

Where is the study run from?
Henan University, Kyungil University in South Korea, and Wangkui County Health Bureau, China

When is the study starting and how long is it expected to run for?
September 2024 to May 2025

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Yongheng Zhao, zyh1996@ldy.edu.rs, zyh19960705@gmail.com

Contact information

Dr Yongheng Zhao
Public, Scientific, Principal Investigator

Wangkui County, Suihua City, Heilongjiang Province
Kaifeng
475001
China

Phone +86 13029925007
Email zyh1996@ldy.edu.rs

Study information

Study design12-week single-center three-arm parallel-group, randomized controlled trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Community, Fitness/sport facility, Hospital, University/medical school/dental school
Study typePrevention, Treatment, Efficacy
Participant information sheet 47700_PIS [Chinese].pdf
Scientific titleA 12-week randomised controlled trial comparing the effects of HIIT and MICT on glycemic control, lipid metabolism, liver enzymes, and cardiovascular function in adults with metabolic syndrome
Study acronymHIIT-MICT MetS Trial
Study objectivesTo compare the effects of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) on glycemic control, lipid metabolism, hepatic function, systemic inflammation, and heart rate recovery in middle-aged adults with metabolic syndrome. A secondary objective is to explore potential sex-specific differences in intervention responsiveness.
Ethics approval(s)

Approved 01/11/2024, Wangkui County Health and Wellness Bureau (No.18 Zhongyang Avenue, Wangkui County, Suihua City, Heilongjiang Province, 152100, China; +86 13298751511; wyj1973@ldy.edu.rs), ref: WLJ-2024-032

Health condition(s) or problem(s) studiedMetabolic syndrome, including components such as hypertension, dyslipidemia (elevated triglycerides, low HDL-C), impaired glucose regulation (elevated fasting glucose or HbA1c), and abdominal obesity. The study population consists of middle-aged adults at high risk of cardiometabolic disorders, aiming to evaluate the efficacy of exercise interventions for cardiometabolic risk reduction and disease prevention.
InterventionThis study is a 12-week, single-center, three-arm, parallel-group, randomized controlled trial (RCT) designed to compare the effects of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) on multiple cardiometabolic health outcomes in middle-aged adults with metabolic syndrome.

A total of 90 participants (aged 45–65) with at least one component of metabolic syndrome were recruited from Wangkui County, Heilongjiang Province, China. After screening, eligible participants were stratified by sex and randomly assigned (1:1:1) to one of three groups: HIIT, MICT, or non-exercise control (CON). Randomization was performed using a computer-generated block randomization sequence (block size = 6) by an independent statistician. Allocation was concealed using sequentially numbered, opaque, sealed envelopes. Due to the nature of the intervention, participant blinding was not feasible, but outcome assessors and data analysts were blinded to group allocation.

The two structured exercise interventions and one non-exercise control group are as follows:

1. The HIIT (High-Intensity Interval Training) group performed a 12-week intervention, 3 times per week, using a 4×4 protocol adapted from Helgerud et al. Each session consisted of a 5-minute warm-up at 50% HRmax, followed by 4 intervals of 4 minutes at 85–95% HRmax, interspersed with 4 minutes of active recovery at 50–60% HRmax, and concluded with a cooldown. Sessions were conducted on treadmills or cycling ergometers, supervised by certified trainers.

2. The MICT (Moderate-Intensity Continuous Training) group completed a 12-week aerobic training program, 5 times per week, at 60–70% HRmax. Each session lasted approximately 45 minutes and involved continuous brisk walking, jogging, or cycling. Heart rate monitors (Polar H10) were used to ensure intensity adherence.

3. The Control group received no structured exercise but maintained their usual lifestyle. Participants attended health education sessions to control for nonspecific effects.

Primary outcomes were changes in fasting blood glucose (FBG) and glycated hemoglobin (HbA1c). Secondary outcomes included lipid profile (TG, HDL-C, LDL-C), BMI, alanine aminotransferase (ALT), uric acid (UA), high-sensitivity C-reactive protein (hs-CRP), and heart rate recovery (HRR), assessed at baseline, mid-intervention (week 6), and post-intervention (week 12).

The study adhered to the ethical principles of the Declaration of Helsinki and was approved by the Health Commission of Wangkui County (Approval No.: WYHE-2024-01). All participants provided written informed consent before enrollment.

All exercise sessions took place at fitness facilities or health centers in Wangkui County, with medical supervision and safety monitoring. Intervention fidelity was tracked through electronic attendance logs and training records.
Intervention typeBehavioural
Primary outcome measureChange in fasting blood glucose (FBG) and glycated hemoglobin (HbA1c) levels were measured using standardized venous blood assays in a central laboratory from at baseline (T1), mid-intervention (T2, week 6), and post-intervention (T3, week 12)
Secondary outcome measuresThe following secondary outcome measures were conducted using standardized protocols under blinded laboratory conditions. Intermediate measurements were taken at week 6 to observe dynamic responses to intervention:
1. Change in triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) levels measured using fasting venous blood samples in a central laboratory from baseline to week 12
2. Change in body mass index (BMI), calculated from measured weight and height, assessed at baseline, week 6, and week 12
3. Change in serum alanine aminotransferase (ALT) levels, used as a marker of liver function, measured using standardized procedures from baseline to week 12
4. Change in serum uric acid (UA) levels measured using biochemical assays from baseline to week 12
5. Change in high-sensitivity C-reactive protein (hs-CRP) levels, as an index of systemic inflammation, measured using standardized procedures from baseline to week 12
6. Change in heart rate recovery (HRR), defined as the drop in heart rate within 1 minute after exercise cessation, and measured using Polar H10 monitors at week 0, 6, and 12
Overall study start date01/09/2024
Completion date31/05/2025

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit40 Years
Upper age limit60 Years
SexBoth
Target number of participants120
Total final enrolment78
Key inclusion criteria1. Adults aged 40 to 60 years
2. Diagnosed with metabolic syndrome based on at least three of the following criteria (as per IDF or Chinese guidelines):
2.1. Elevated waist circumference
2.2. Elevated triglycerides (≥150 mg/dL)
2.3. Reduced HDL cholesterol (<40 mg/dL for men, <50 mg/dL for women)
2.4. Elevated blood pressure (SBP ≥130 mmHg or DBP ≥85 mmHg)
2.5. Elevated fasting blood glucose (≥100 mg/dL)
3. Able and willing to provide written informed consent
4. Physically capable of participating in supervised moderate-to-high intensity exercise programs
5. No change in medication for at least 3 months prior to enrolment
Key exclusion criteria1. Diagnosed with severe cardiovascular disease (e.g., unstable angina, recent myocardial infarction within 6 months)
2. Diagnosed with severe pulmonary disease or respiratory insufficiency
3. Diagnosed with advanced liver or renal dysfunction
4. History of stroke or other neurological disorders affecting motor ability
5. Musculoskeletal disorders or injuries preventing safe exercise participation
6. Currently receiving chemotherapy, radiotherapy, or immunosuppressive treatment
7. Diagnosed psychiatric illness or cognitive impairment that limits informed consent or compliance
8. Participation in any other clinical trial within the past 3 months
9. Pregnancy or planning to become pregnant during the study period
10. Refusal or inability to provide written informed consent
Date of first enrolment01/11/2024
Date of final enrolment30/11/2024

Locations

Countries of recruitment

  • China

Study participating centre

Wangkui County
Suihua City, Heilongjiang province
Kaifeng
475001
China

Sponsor information

Wangkui County Health Commission
Government

No. 98 Xinhua Street, Wangkui County
Suihua
475001
China

Phone +86 13298751511
Email 819960705@qq.com

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/11/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryPublished as a supplement to the results publication
Publication and dissemination planPlanned publication in a peer-reviewed journal
IPD sharing planThe datasets generated and/or analysed during the current study will be published as a supplement to the results publication. IPD will not be shared due to privacy and ethical concerns. Aggregated results only will be made available through publications.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 23/07/2025 No Yes
Protocol file 23/07/2025 No No

Additional files

47700_Protocol [Chinese].pdf
47700_PIS [Chinese].pdf

Editorial Notes

21/07/2025: Study's existence confirmed by the Exercise Intervention Clinical Research Ethics Review for the Wangkui County Health Bureau, China.