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The Effect of HIIT, MICT in Patients With Myocardial Infarction

Primary Purpose

Myocardial Infarction, Cardiopulmonary Disease, Training Group, Sensitivity

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High Intensity Interval Training(HIIT）
Moderate Intensity Continuous Training(MICT）
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring High Intensity Intermittent Training, Myocardial Infarction, Moderate Intensity Continuous Training, Cardiac Rehabilitation, Cardiopulmonary exercise testing

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guangdong Cardiovascular Institute, Guangdong Provincial People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

High Intensity Interval Training(HIIT)

Moderate Intensity Continuous Training(MICT)

Control Group

Arm Description

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.

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)

No additional rehabilitation treatment or physical exercise was added in Control Group.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
The effect of HIIT/MICT on body fat
The effect of HIIT/MICT on body fat
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
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.

Full Information

First Posted
April 22, 2021
Last Updated
December 8, 2021
Sponsor
Guangdong Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04863677
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Cardiopulmonary Disease, Training Group, Sensitivity
Keywords
High Intensity Intermittent Training, Myocardial Infarction, Moderate Intensity Continuous Training, Cardiac Rehabilitation, Cardiopulmonary exercise testing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Interval Training(HIIT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Moderate Intensity Continuous Training(MICT)
Arm Type
Experimental
Arm Description
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)
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No additional rehabilitation treatment or physical exercise was added in Control Group.
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Interval Training(HIIT）
Intervention Description
Last 12 weeks (3 sessions per week)
Intervention Type
Behavioral
Intervention Name(s)
Moderate Intensity Continuous Training(MICT）
Intervention Description
Moderate Intensity Continuous Training(MICT）
Primary Outcome Measure Information:
Title
The effect of HIIT/MICT on VO2peak
Description
Changes in VO2peak after 3-month cardiac rehabilitation training ( HIIT, MICT), assessed by cardiopulmonary exercise testing.
Time Frame
3 months
Title
Evaluate the degree of cardiac fibrosis in 3 groups by cardiac magnetic resonance
Description
The effect of HIIT/MICT on myocardial fibrosis in patients with MI, assessed by cardiac magnetic resonance.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The changes of HIIT/MICT on Stromelysin-2
Description
Blood samples will be taken to detect Stromelysin-2, to evaluate the effect of HIIT/MICT on Stromelysin-2.
Time Frame
3 months
Title
The effect of HIIT/MICT on endothelial function as assessed by the Endo-PAT2000
Description
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.
Time Frame
3 months
Title
The effect of HIIT/MICT on microvascular obstruction as assessed by cardiac magnetic resonance
Description
The effect of HIIT/MICT on microvascular obstruction,assessed by cardiac magnetic resonance.
Time Frame
3 months
Title
The effect of HIIT/MICT on body fat
Description
The effect of HIIT/MICT on body fat
Time Frame
3 months
Title
The effect of HIIT/MICT on quality of life as assessed by SF-36
Description
The effect of HIIT/MICT on quality of life as assessed by SF-36
Time Frame
3 months
Title
The effect of HIIT/MICT on the incidence of arrhythmia, assessed by 24h dynamic electrocardiogram
Description
The effect of HIIT/MICT on the incidence of arrhythmia,assessed by 24h dynamic electrocardiogram.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
all-cause mortality within one year
Description
all-cause mortality within one year
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingshan Geng
Phone
13922205818
Email
gengqsh@163.net
First Name & Middle Initial & Last Name or Official Title & Degree
Huan Ma
Phone
15018755932
Email
mahuan@gdph.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingshan Geng
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingshan Geng
Phone
13922205818
Email
gengqsh@163.net
First Name & Middle Initial & Last Name & Degree
Huan Ma
Phone
15018755932
Email
mahuan@gdph.org.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
35479268
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.
Results Reference
derived

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The Effect of HIIT, MICT in Patients With Myocardial Infarction

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