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Completed

NCT Number: NCT04863677

The Effect of HIIT, MICT in Patients With Myocardial Infarction

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 .

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

High Intensity Interval Training(HIIT)

Behavioral

Last 12 weeks (3 sessions per week)

Moderate Intensity Continuous Training(MICT)

Behavioral

Moderate Intensity Continuous Training(MICT)

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. The effect of HIIT/MICT on endothelial function as assessed by the Endo-PAT2000

    Time frame: 3 months

    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.

  2. The effect of HIIT/MICT on body circumference

    Time frame: 3 months

    The effect of HIIT/MICT on body circumference

  3. The effect of HIIT/MICT on quality of life as assessed by SF-36

    Time frame: 3 months

    The effect of HIIT/MICT on quality of life as assessed by SF-36

  4. The effect of HIIT and MICT on depression

    Time frame: Baseline and 3months

    Depression is assessed by Patient Health Questionnaire - 9 (PHQ-9)

  5. The effect of HIIT and MICT on anxiety

    Time frame: Baseline and 3months

    Anxiety is assessed by General anxiety disorder-7 (GAD-7)

Other outcomes

  1. all-cause mortality within one year

    Time frame: one year

    all-cause mortality within one year

  2. Peak oxygen uptake change

    Time frame: 1year, 2year and 5 year

    Changes in VO2peak after cardiac rehabilitation training ( HIIT, MICT), assessed by cardiopulmonary exercise testing.

  3. The degree of cardiac fibrosis

    Time frame: 1year, 2year and 5year

    Evaluate the degree of cardiac fibrosis in 3 groups by cardiac magnetic resonance

  4. Major adverse cardiovascular events

    Time frame: 1 year, 2 year and 5year

    Cardiac death, non-fatal myocardial infarction, non-fatal stroke, cardiac readmission, and revascularization

  5. The effect of HIIT and MICT on cardiac function by MRI

    Time frame: Baseline and 12 weeks

    cardiac function is assessed by MRI

  6. The effect of HIIT and MICT on other cardiopulmonary exercise testing parameters

    Time frame: Baseline and 12 weeks

    Other cardiopulmonary exercise testing parameters except for peak oxygen uptake.

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Collaborators

  • Zhongshan Hospital Of Traditional Chinese Medicine

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 28, 2021
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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