NCT04863677

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

4.4 years

First QC Date

April 22, 2021

Last Update Submit

January 30, 2026

Conditions

Myocardial InfarctionCardiopulmonary DiseaseTraining Group, Sensitivity

Keywords

High Intensity Intermittent TrainingMyocardial InfarctionModerate Intensity Continuous TrainingCardiac RehabilitationCardiopulmonary exercise testing

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • The effect of HIIT/MICT on endothelial function as assessed by the Endo-PAT2000

    3 months

  • The effect of HIIT/MICT on body circumference

    3 months

  • The effect of HIIT/MICT on quality of life as assessed by SF-36

    3 months

  • The effect of HIIT and MICT on depression

    Baseline and 3months

  • The effect of HIIT and MICT on anxiety

    Baseline and 3months

Other Outcomes (6)

  • all-cause mortality within one year

    one year

  • Peak oxygen uptake change

    1year, 2year and 5 year

  • The degree of cardiac fibrosis

    1year, 2year and 5year

  • +3 more other outcomes

Study Arms (3)

High Intensity Interval Training(HIIT)

EXPERIMENTAL

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）

Moderate Intensity Continuous Training(MICT)

EXPERIMENTAL

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）

Control Group

NO INTERVENTION

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

Interventions

High Intensity Interval Training(HIIT）BEHAVIORAL

Last 12 weeks (3 sessions per week)

High Intensity Interval Training(HIIT)
Moderate Intensity Continuous Training(MICT）BEHAVIORAL

Moderate Intensity Continuous Training(MICT）

Moderate Intensity Continuous Training(MICT)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

  • 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.

    PMID: 35479268DERIVED

MeSH Terms

Conditions

Myocardial InfarctionPulmonary Heart DiseaseHypersensitivity

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisImmune System Diseases

Study Officials

  • Qingshan Geng

    Guangdong Provincial People's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2021

First Posted

April 28, 2021

Study Start

May 1, 2021

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
5 years

Locations

CN(1)