The Effect of HIIT, MICT in Patients With Myocardial Infarction

NCT ID: NCT04863677

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2025-10-31

Brief Summary

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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

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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).

Conditions

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Myocardial Infarction Cardiopulmonary Disease Training Group, Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

High Intensity Interval Training(HIIT)

Intervention Type BEHAVIORAL

Last 12 weeks (3 sessions per week)

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)

Group Type EXPERIMENTAL

Moderate Intensity Continuous Training(MICT)

Intervention Type BEHAVIORAL

Moderate Intensity Continuous Training(MICT)

Control Group

No additional rehabilitation treatment or physical exercise was added in Control Group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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High Intensity Interval Training(HIIT)

Last 12 weeks (3 sessions per week)

Intervention Type BEHAVIORAL

Moderate Intensity Continuous Training(MICT)

Moderate Intensity Continuous Training(MICT)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Aged 18 -75 years
2. 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))
3. Willing and able to attend the complete cardiac rehabilitation(CR)program on their own,assigned the Informed consent form.
4. Complete the cardiopulmonary exercise testing (CPET) at enrollment or has the CPET report within 1 month.

Exclusion Criteria

1. High-intensity exercise frequently
2. Currently participating in any other clinical trials
3. 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)
4. Dementia ; disability or sports contraindication
5. Severe acute liver failure
6. Severe acute renal failure
7. Unstable vital signs
8. Site investigators consider that the patient will be unable to complete the study and/or attend for follow-up.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongshan Hospital Of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qingshan Geng

Role: STUDY_CHAIR

Guangdong Provincial People's Hospital

Locations

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Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qingshan Geng

Role: CONTACT

13922205818

Huan Ma

Role: CONTACT

15018755932

Facility Contacts

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Qingshan Geng

Role: primary

13922205818

Huan Ma

Role: backup

15018755932

References

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Shi 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.

Reference Type DERIVED
PMID: 35479268 (View on PubMed)

Other Identifiers

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2020208H(R1)

Identifier Type: -

Identifier Source: org_study_id

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