Clinical trial NCT04863677: The Effect of HIIT, MICT in Patients With Myocardial Infarction
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Cardiopulmonary Disease
Training Group, Sensitivity
Keywords: High Intensity Intermittent Training
Myocardial Infarction
Moderate Intensity Continuous Training
Cardiac Rehabilitation
Cardiopulmonary exercise testing
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Zhongshan Hospital Of Traditional Chinese Medicine
First posted: 2021-04-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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).

Eligibility 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.

Primary outcomes:
measure: The effect of HIIT/MICT on VO2peak
timeFrame: 3 months
measure: Evaluate the degree of cardiac fibrosis in 3 groups by cardiac magnetic resonance
timeFrame: 3 months
Secondary outcomes:
measure: The changes of HIIT/MICT on Stromelysin-2
timeFrame: 3 months
measure: The effect of HIIT/MICT on endothelial function as assessed by the Endo-PAT2000
timeFrame: 3 months
measure: The effect of HIIT/MICT on microvascular obstruction as assessed by cardiac magnetic resonance
timeFrame: 3 months
measure: The effect of HIIT/MICT on body fat
timeFrame: 3 months
measure: The effect of HIIT/MICT on quality of life as assessed by SF-36
timeFrame: 3 months
measure: The effect of HIIT/MICT on the incidence of arrhythmia, assessed by 24h dynamic electrocardiogram
timeFrame: 3 months
Other outcomes:
measure: all-cause mortality within one year
timeFrame: one year
measure: Peak oxygen uptake change
timeFrame: 1year, 2year and 5 year
measure: The degree of cardiac fibrosis
timeFrame: 1year, 2year and 5year
measure: Major adverse cardiovascular events
timeFrame: 1 year, 2 year and 5year
Locations:
city: Guangzhou
country: China
facility: Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Qingshan Geng
role: STUDY_CHAIR
References:
citation: 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.