The Effect of HIIT, MICT in Patients With Myocardial Infarction

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 .

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Cardiopulmonary Disease; Training Group, Sensitivity
• Intervention / Treatment: Behavioral: High Intensity Interval Training(HIIT）; Behavioral: Moderate Intensity Continuous Training(MICT）

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 Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: High Intensity Interval Training(HIIT）; Last 12 weeks (3 sessions per week)
Experimental: 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)	Behavioral: Moderate Intensity Continuous Training(MICT）; Moderate Intensity Continuous Training(MICT）
No Intervention: Control Group; No additional rehabilitation treatment or physical exercise was added in Control Group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of HIIT/MICT on VO2peak	Changes in VO2peak after 3-month cardiac rehabilitation training ( HIIT, MICT), assessed by cardiopulmonary exercise testing.	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	3 months
The effect of HIIT/MICT on body circumference	The effect of HIIT/MICT on body circumference	3 months
The effect of HIIT and MICT on depression	Depression is assessed by Patient Health Questionnaire - 9 (PHQ-9)	Baseline and 3months
The effect of HIIT and MICT on anxiety	Anxiety is assessed by General anxiety disorder-7 (GAD-7)	Baseline and 3months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality within one year	all-cause mortality within one year	one year
Peak oxygen uptake change	Changes in VO2peak after cardiac rehabilitation training ( HIIT, MICT), assessed by cardiopulmonary exercise testing.	1year, 2year and 5 year
The degree of cardiac fibrosis	Evaluate the degree of cardiac fibrosis in 3 groups by cardiac magnetic resonance	1year, 2year and 5year
Major adverse cardiovascular events	Cardiac death, non-fatal myocardial infarction, non-fatal stroke, cardiac readmission, and revascularization	1 year, 2 year and 5year
The effect of HIIT and MICT on cardiac function by MRI	cardiac function is assessed by MRI	Baseline and 12 weeks
The effect of HIIT and MICT on other cardiopulmonary exercise testing parameters	Other cardiopulmonary exercise testing parameters except for peak oxygen uptake.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Collaborators: Zhongshan Hospital Of Traditional Chinese Medicine
• Investigators: Study Chair: Qingshan Geng, Guangdong Provincial People's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Myocardial Infarction; Cardiac Rehabilitation; Cardiopulmonary exercise testing; High Intensity Intermittent Training; Moderate Intensity Continuous Training
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Immune System Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Hypersensitivity; Myocardial Infarction; Pulmonary Heart Disease
• Other Study ID Numbers: 2020208H(R1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 5 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No