Myocardial InfarctionNCT04863677
The Effect of HIIT, MICT in Patients With Myocardial Infarction
A study testing High Intensity Interval Training(HIIT） and Moderate Intensity Continuous Training(MICT） in people with Myocardial Infarction and Cardiopulmonary Disease, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This study will investigate the effect of a 12-weeks cardiac rehabilitation training (HIIT, MICT) program on VO2peak and cardiac fibrosis in patients, and evaluate the effects of HIIT on endothelial function, microvascular obstruction, body fat, inflammation, arrhythmia and psychology . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction, Cardiopulmonary Disease, Training Group, Sensitivity
- What is being tested?
- High Intensity Interval Training(HIIT） and Moderate Intensity Continuous Training(MICT）
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 -75 years
- Acute myocardial infarction (AMI) patients between 6 weeks and 3 months and had been underwent revascularization, and New York Heart Association functional classification (NYHA) Class I-III; (AMI confirmed by the World Health Organization definition (presence of symptoms of ischemia and changes in electrocardiogram) or the Third Universal Definition of Myocardial Infarction (elevation of a cardiac biomarker along with presence of either symptoms of myocardial infarction or changes in electrocardiogram))
- Willing and able to attend the complete cardiac rehabilitation(CR)program on their own，assigned the Informed consent form.
- Complete the cardiopulmonary exercise testing (CPET) at enrollment or has the CPET report within 1 month.
Who cannot join
- High-intensity exercise frequently
- Currently participating in any other clinical trials
- Have any other diseases which limit their life to less than a year (e.g. severe valvular disease, recurrent ventricular arrhythmias, NYHA Class IV heart failure, severe aortic incompetence, severe atrial fibrillation, cancers, and end-stage renal or liver disease)
- Dementia ; disability or sports contraindication
- Severe acute liver failure
- Severe acute renal failure
- Unstable vital signs
- Site investigators consider that the patient will be unable to complete the study and/or attend for follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000
About this study
Official title: Effect of High-Intensity Interval Training, Moderate Continuous Training, or Guideline-Based Physical Activity on Peak Oxygen Uptake and Myocardial Fibrosis in Patients With Myocardial Infarction: Protocol for a Randomized Controlled Trial
This study will investigate the effect of a 12-weeks cardiac rehabilitation training (HIIT, MICT) program on VO2peak and cardiac fibrosis in patients, and evaluate the effects of HIIT on endothelial function, microvascular obstruction, body fat, inflammation, arrhythmia and psychology .
Read the detailed description
Eligible and consenting patients are randomized (block randomization) in a 1:1:1 ratio. According to the number of 180 samples calculated by the sample size, the random number table containing 1-180 ( including shedding cases ) was obtained by the computer. Case number will be assigned to participants in each group according to the order of grouping, and each case number corresponded to Group1(HIIT), 2(MICT) or 3(Control) according to the random number.
The HIIT sessions include brief, intermittent bouts of high-intensity exercise interspersed with periods of low-intensity exercise (active recovery). HIIT include 20 intervals of high-intensity (30-60s at rating of perceived exertion (RPE; Borg scale of 6-20) of 15 to 17) and low-intensity (1min at RPE <10 or totally rest). The whole exercise cycle takes around 40-50 minutes (Figure 2). In MICT Group, patients perform 40-50 minutes at a RPE of 12 to 14(a total of 4 groups, each group 5-8 min, interspersed with 2-minute rest)(Figure 3). HIIT and MICT are performed only during supervised sessions with non-consecutive 3 days/week. And all patients are supervised by professional CR team. After assessing by therapists and doctors, participants also can perform three days of home-based exercises guided by wearing a sports bracelet.
The CR program includes 36 sessions supervised exercises, pharmacological counseling, patient education, catering management, smoking cessation counseling, stress management, and psychological counseling. A standard 36 sessions of CR usually lasts 12 weeks (three sessions per week).
- Being tested
- High Intensity Interval Training(HIIT）, Moderate Intensity Continuous Training(MICT）
- Keywords
- High Intensity Intermittent Training, Myocardial Infarction, Moderate Intensity Continuous Training, Cardiac Rehabilitation, Cardiopulmonary exercise testing
- Medical subject headings
- Myocardial Infarction, Pulmonary Heart Disease, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval Training(HIIT）Behavioural
Last 12 weeks (3 sessions per week)
Moderate Intensity Continuous Training(MICT）Behavioural
Moderate Intensity Continuous Training(MICT）
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training(HIIT) | Experimental | The HIIT sessions include brief, intermittent bouts of high-intensity exercise interspersed with periods of low-intensity exercise (active recovery).HIIT include 20 intervals of high-intensity (30-60s at rating of perceived exertion (RPE; Borg scale of 6-20) of 15 to 17) and low-intensity (1min at RPE <10 or totally rest). The whole exercise cycle takes around 40-50 minutes. Receives: Behavioral: High Intensity Interval Training(HIIT） |
| Moderate Intensity Continuous Training(MICT) | Experimental | Patients perform 40-50 minutes at a RPE of 12 to 14(a total of 4 groups, each group 5-8 min, interspersed with 2-minute rest) Receives: Behavioral: Moderate Intensity Continuous Training(MICT） |
| Control Group | No intervention | No additional rehabilitation treatment or physical exercise was added in Control Group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of HIIT/MICT on VO2peak
Changes in VO2peak after 3-month cardiac rehabilitation training ( HIIT, MICT), assessed by cardiopulmonary exercise testing.
Measured: 3 months
Evaluate the degree of cardiac fibrosis in 3 groups by cardiac magnetic resonance
The effect of HIIT/MICT on myocardial fibrosis in patients with MI, assessed by cardiac magnetic resonance.
Measured: 3 months
Secondary outcomes (5)
The effect of HIIT/MICT on endothelial function as assessed by the Endo-PAT2000
Endothelial function will be assessed using the Endo-PAT2000 (Itamar Medical), which measures the finger pulse volume amplitude (PVA) using volume plethysmography technology to reflect peripheral blood volume changes.
Measured: 3 months
The effect of HIIT/MICT on body circumference
The effect of HIIT/MICT on body circumference
Measured: 3 months
The effect of HIIT/MICT on quality of life as assessed by SF-36
The effect of HIIT/MICT on quality of life as assessed by SF-36
Measured: 3 months
The effect of HIIT and MICT on depression
Depression is assessed by Patient Health Questionnaire - 9 (PHQ-9)
Measured: Baseline and 3months
The effect of HIIT and MICT on anxiety
Anxiety is assessed by General anxiety disorder-7 (GAD-7)
Measured: Baseline and 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 May 2021
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongshan Hospital Of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Qingshan Geng, Study chair, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863677
- Sponsor's protocol ID
- 2020208H(R1)
- Status last verified
- Jan 2026
- First submitted
- 22 Apr 2021
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data (including data dictionaries) from individuals consent to the present project, after de-identification, will be shared that include all been discussed in this article. Study protocol, statistical analysis plan, and analytic code are available for sharing. We anticipate data sharing will be ready 6 months after the publication of the primary end point of this project, and ending 36 months following article publication. Our data may be shared with investigators who provide a methodologically sound proposal with approval of an independent review committee. Proposals should be directed to gengqsh@163.net. To gain access, data requestors will need to sign a data access agreement with our institution. Data are available for 5 years at the data management center.
Publications
Chen R, Yang Y, Wu X, Wu Z, Xu Y, Luo W, Mo C, Luo X, Cao L, Liu H, Xie J. Fat-Induced Signal-oscillation Analysis Enhances Myocardial Iron Deposition Detection in Myocardial Infarction on Cardiac T2* Mapping. J Cardiovasc Magn Reson. 2026 Jun 29:102771. doi: 10.1016/j.jocmr.2026.102771. Online ahead of print.
PubMed 42372973Shi X, Chen X, Qiu X, Luo W, Luo X, Liu H, Geng Q, Ma H, Xue L, Guo L. Effect of High-Intensity Interval Training, Moderate Continuous Training, or Guideline-Based Physical Activity on Peak Oxygen Uptake and Myocardial Fibrosis in Patients With Myocardial Infarction: Protocol for a Randomized Controlled Trial. Front Cardiovasc Med. 2022 Apr 11;9:860071. doi: 10.3389/fcvm.2022.860071. eCollection 2022.
PubMed 35479268
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Intensity Interval Training, Moderate Continuous Training, or Guideline-Based Physical Activity on Peak Oxygen Uptake and Myocardial Fibrosis in Patients With Myocardial Infarction: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04863677
- Acronym / sponsor ID
- 2020208H(R1)
- Keywords
- High Intensity Intermittent Training, Myocardial Infarction, Moderate Intensity Continuous Training, Cardiac Rehabilitation, Cardiopulmonary exercise testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Zhongshan Hospital Of Traditional Chinese Medicine
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the effect of a 12-weeks cardiac rehabilitation training (HIIT, MICT) program on VO2peak and cardiac fibrosis in patients, and evaluate the effects of HIIT on endothelial function, microvascular obstruction, body fat, inflammation, arrhythmia and psychology .
Detailed description
Eligible and consenting patients are randomized (block randomization) in a 1:1:1 ratio. According to the number of 180 samples calculated by the sample size, the random number table containing 1-180 ( including shedding cases ) was obtained by the computer. Case number will be assigned to participants in each group according to the order of grouping, and each case number corresponded to Group1(HIIT), 2(MICT) or 3(Control) according to the random number.
The HIIT sessions include brief, intermittent bouts of high-intensity exercise interspersed with periods of low-intensity exercise (active recovery). HIIT include 20 intervals of high-intensity (30-60s at rating of perceived exertion (RPE; Borg scale of 6-20) of 15 to 17) and low-intensity (1min at RPE <10 or totally rest). The whole exercise cycle takes around 40-50 minutes (Figure 2). In MICT Group, patients perform 40-50 minutes at a RPE of 12 to 14(a total of 4 groups, each group 5-8 min, interspersed with 2-minute rest)(Figure 3). HIIT and MICT are performed only during supervised sessions with non-consecutive 3 days/week. And all patients are supervised by professional CR team. After assessing by therapists and doctors, participants also can perform three days of home-based exercises guided by wearing a sports bracelet.
The CR program includes 36 sessions supervised exercises, pharmacological counseling, patient education, catering management, smoking cessation counseling, stress management, and psychological counseling. A standard 36 sessions of CR usually lasts 12 weeks (three sessions per week).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training(HIIT) | Experimental | Behavioral: High Intensity Interval Training(HIIT）The HIIT sessions include brief, intermittent bouts of high-intensity exercise interspersed with periods of low-intensity exercise (active recovery).HIIT include 20 intervals of high-intensity (30-60s at rating of perceived exertion (RPE; Borg scale of 6-20) of 15 to 17) and low-intensity (1min at RPE <10 or totally rest). The whole exercise cycle takes around 40-50 minutes. |
| Moderate Intensity Continuous Training(MICT) | Experimental | Behavioral: Moderate Intensity Continuous Training(MICT）Patients perform 40-50 minutes at a RPE of 12 to 14(a total of 4 groups, each group 5-8 min, interspersed with 2-minute rest) |
| Control Group | No intervention | –No additional rehabilitation treatment or physical exercise was added in Control Group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 -75 years
- Acute myocardial infarction (AMI) patients between 6 weeks and 3 months and had been underwent revascularization, and New York Heart Association functional classification (NYHA) Class I-III; (AMI confirmed by the World Health Organization definition (presence of symptoms of ischemia and changes in electrocardiogram) or the Third Universal Definition of Myocardial Infarction (elevation of a cardiac biomarker along with presence of either symptoms of myocardial infarction or changes in electrocardiogram))
- Willing and able to attend the complete cardiac rehabilitation(CR)program on their own，assigned the Informed consent form.
- Complete the cardiopulmonary exercise testing (CPET) at enrollment or has the CPET report within 1 month.
Key exclusion criteria (8 listed)
- High-intensity exercise frequently
- Currently participating in any other clinical trials
- Have any other diseases which limit their life to less than a year (e.g. severe valvular disease, recurrent ventricular arrhythmias, NYHA Class IV heart failure, severe aortic incompetence, severe atrial fibrillation, cancers, and end-stage renal or liver disease)
- Dementia ; disability or sports contraindication
- Severe acute liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval Training(HIIT）Last 12 weeks (3 sessions per week) | Behavioural | High Intensity Interval Training(HIIT) |
| Moderate Intensity Continuous Training(MICT）Moderate Intensity Continuous Training(MICT） | Behavioural | Moderate Intensity Continuous Training(MICT) |
Primary outcome
The effect of HIIT/MICT on VO2peak
Time frame: 3 months
Changes in VO2peak after 3-month cardiac rehabilitation training ( HIIT, MICT), assessed by cardiopulmonary exercise testing.
Evaluate the degree of cardiac fibrosis in 3 groups by cardiac magnetic resonance
Time frame: 3 months
The effect of HIIT/MICT on myocardial fibrosis in patients with MI, assessed by cardiac magnetic resonance.
5 secondary outcomes
The effect of HIIT/MICT on endothelial function as assessed by the Endo-PAT2000
Time frame: 3 months
The effect of HIIT/MICT on body circumference
Time frame: 3 months
The effect of HIIT/MICT on quality of life as assessed by SF-36
Time frame: 3 months
The effect of HIIT and MICT on depression
Time frame: Baseline and 3months
The effect of HIIT and MICT on anxiety
Time frame: Baseline and 3months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Derived from this study: PubMed 42372973Chen R, Yang Y, Wu X, Wu Z, Xu Y, Luo W, Mo C, Luo X, Cao L, Liu H, Xie J. Fat-Induced Signal-oscillation Analysis Enhances Myocardial Iron Deposition Detection in Myocardial Infarction on Cardiac T2* Mapping. J Cardiovasc Magn Reson. 2026 Jun 29:102771. doi: 10.1016/j.jocmr.2026.102771. Online ahead of print.
- Derived from this study: PubMed 35479268Shi X, Chen X, Qiu X, Luo W, Luo X, Liu H, Geng Q, Ma H, Xue L, Guo L. Effect of High-Intensity Interval Training, Moderate Continuous Training, or Guideline-Based Physical Activity on Peak Oxygen Uptake and Myocardial Fibrosis in Patients With Myocardial Infarction: Protocol for a Randomized Controlled Trial. Front Cardiovasc Med. 2022 Apr 11;9:860071. doi: 10.3389/fcvm.2022.860071. eCollection 2022.
- Individual participant dataSharing planned: Yes. All data (including data dictionaries) from individuals consent to the present project, after de-identification, will be shared that include all been discussed in this article. Study protocol, statistical analysis plan, and analytic code are available for sharing. We anticipate data sharing will be ready 6 months after the publication of the primary end point of this project, and ending 36 months following article publication. Our data may be shared with investigators who provide a methodologically sound proposal with approval of an independent review committee. Proposals should be directed to gengqsh@163.net. To gain access, data requestors will need to sign a data access agreement with our institution. Data are available for 5 years at the data management center.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qingshan Geng study chair
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training(HIIT） and Moderate Intensity Continuous Training(MICT） in people with Myocardial Infarction and Cardiopulmonary Disease, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of HIIT/MICT on VO2peak (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04863677, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.