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The Effect of HIIT, MICT in Patients With Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT04863677
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : December 9, 2021
Sponsor:
Information provided by (Responsible Party):
Guangdong Provincial People's Hospital

Study Description
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Brief 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 .

Condition or disease Intervention/treatment Phase
Myocardial Infarction Cardiopulmonary Disease Training Group, Sensitivity Behavioral: High Intensity Interval Training(HIIT） Behavioral: Moderate Intensity Continuous Training(MICT） Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. The changes of HIIT/MICT on Stromelysin-2 [ Time Frame: 3 months ]
    Blood samples will be taken to detect Stromelysin-2, to evaluate the effect of HIIT/MICT on Stromelysin-2.

  2. 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.

  3. The effect of HIIT/MICT on microvascular obstruction as assessed by cardiac magnetic resonance [ Time Frame: 3 months ]
    The effect of HIIT/MICT on microvascular obstruction,assessed by cardiac magnetic resonance.

  4. The effect of HIIT/MICT on body fat [ Time Frame: 3 months ]
    The effect of HIIT/MICT on body fat

  5. 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

  6. The effect of HIIT/MICT on the incidence of arrhythmia, assessed by 24h dynamic electrocardiogram [ Time Frame: 3 months ]
    The effect of HIIT/MICT on the incidence of arrhythmia,assessed by 24h dynamic electrocardiogram.


Other Outcome Measures:
  1. all-cause mortality within one year [ Time Frame: one year ]
    all-cause mortality within one year


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04863677


Contacts
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Contact: Qingshan Geng 13922205818 gengqsh@163.net
Contact: Huan Ma 15018755932 mahuan@gdph.org.cn

Locations
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China, Guangdong
Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Qingshan Geng    13922205818    gengqsh@163.net   
Contact: Huan Ma    15018755932    mahuan@gdph.org.cn   
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Investigators
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Study Chair: Qingshan Geng Guangdong Provincial People's Hospital
More Information
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Responsible Party: Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT04863677    
Other Study ID Numbers: 2020208H(R1)
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: December 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 5 years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guangdong Provincial People's Hospital:
High Intensity Intermittent Training
Myocardial Infarction
Moderate Intensity Continuous Training
Cardiac Rehabilitation
Cardiopulmonary exercise testing
Additional relevant MeSH terms:
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Myocardial Infarction
Pulmonary Heart Disease
Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases