The Effect of HIIT, MICT in Patients With Myocardial Infarction

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04863677
• Other study ID #: 2020208H(R1)
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2021
• Source: Guangdong Provincial People's Hospital
• Contact: Qingshan Geng
• Phone: 13922205818
• Email: gengqsh[@]163.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiopulmonary Disease
• Infarction
• Myocardial Infarction
• Pulmonary Heart Disease
• Training Group, Sensitivity

Intervention

Behavioral:
• High Intensity Interval Training(HIIT)
Last 12 weeks (3 sessions per week)
• Moderate Intensity Continuous Training(MICT)
Moderate Intensity Continuous Training(MICT)

Locations

Country	Name	City	State
China	Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	all-cause mortality within one year	all-cause mortality within one year	one year
Primary	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
Primary	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	The changes of HIIT/MICT on Stromelysin-2	Blood samples will be taken to detect Stromelysin-2, to evaluate the effect of HIIT/MICT on Stromelysin-2.	3 months
Secondary	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
Secondary	The effect of HIIT/MICT on microvascular obstruction as assessed by cardiac magnetic resonance	The effect of HIIT/MICT on microvascular obstruction,assessed by cardiac magnetic resonance.	3 months
Secondary	The effect of HIIT/MICT on body fat	The effect of HIIT/MICT on body fat	3 months
Secondary	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
Secondary	The effect of HIIT/MICT on the incidence of arrhythmia, assessed by 24h dynamic electrocardiogram	The effect of HIIT/MICT on the incidence of arrhythmia,assessed by 24h dynamic electrocardiogram.	3 months