Protocol summary
-
Study aim
-
Compared the Effectiveness of High -volume vs low-volume High-Intensity Interval Training in Myocardial Infarction Patients.
-
Design
-
The study is a randomized controlled clinical trial with a control group, doubl-blind, three-arm, parallel-groups, phase 2 on 128 patients, Randomized by block and stratified method with a randomization ratio of 1: 1: 1.
-
Settings and conduct
-
Place of study: The trial will be conducted in theCardiovascular Therapy Clinic (Healthy Heart Rehabilitation Center) , Khorramabad , Lorestan.
Blinding type: doubl-blind.
How blinding: Medical staff will be blinded to participant randomization assignment.Both participants and outcome assessors are unaware of the allocation of study groups.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: MI type I; At least Six months to two years after diagnosis and angioplasty; 45≤ Age ≤60 years; clinically stable on sinus rhythm; Left ventricular ejection fraction > 40% . Exclusion criteria: Unstable coronary artery disease; uncontrolled hypertension; malignant ventricular arrhythmia; exercise-induced ischemia.
-
Intervention groups
-
Intervention group 1: high-volume HIIT training for 40 minutes.
Intervention group 2: low-volume HIIT training for 20 minutes.
control group: physical activity recommendations.
-
Main outcome variables
-
Serum levels of miR-1, miR208,miR-133, mRNA Caspas3, ontractile biomarkers, inflammatory markers, cardiac function Indicators, quality of life.
General information
-
Reason for update
-
Change the sample size, add the number of dependent variables
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20201022049111N1
Registration date:
2020-11-29, 1399/09/09
Registration timing:
registered_while_recruiting
Last update:
2022-04-21, 1401/02/01
Update count:
1
-
Registration date
-
2020-11-29, 1399/09/09
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-11-19, 1399/08/29
-
Expected recruitment end date
-
2021-04-19, 1400/01/30
-
Actual recruitment start date
-
2020-11-18, 1399/08/28
-
Actual recruitment end date
-
2021-07-21, 1400/04/30
-
Trial completion date
-
2021-11-20, 1400/08/29
-
Scientific title
-
Comparison of the Effectiveness of Cardiac Rehabilitation based on High- volume (HV-HIIT) and low-volume (LV-HIIT) High-Intensity Interval Training on Serum levels of some miRNAs, myocardial contractile biomarkers , Inflammatory and Functional Markers in Myocardial Infarction Patients
-
Public title
-
Effect of High-Intensity Interval Training on Cardiac Rehabilitation among Myocardial Infarction Patients
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
MI type 1 and having an ejection fraction of 40%
At least six to two years have passed since the diagnosis and angioplasty
Be in a stable condition without drug changes
In class II, I have cardiac function.
Maximum metabolic equivalent to or more than 5 MET
Exclusion criteria:
Metabolic diseases such as diabetes and obesity
Variable blood pressure
Congestive heart failure
Dangerous arrhythmias
Liver and kidney failure
Chronic obstructive pulmonary disease
Neuromuscular disorders
-
Age
-
From 45 years old to 60 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Outcome assessor
-
Sample size
-
Target sample size:
128
Actual sample size reached:
128
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
The method of randomization will be the permuted block randomization (42patients per block) with stratification based on age and sex.A random allocation sequence list will be generated using a web-based app, that is, Random.org.An independent research assistant who did not participate in any other parts of the research will be generated and maintained the random allocation sequence list. This independent research assistant will assign group labels to the participants according to the sequence of their entry, referring to the random allocation sequence list to ensure that the other members of the research team did not foresee the group allocation. Allocation concealment will be performed by sequentially numbered sealed opaque envelopes. independent research assistant generated the random allocation sequence and distributed these in serially numbered sealed opaque envelopes. Envelopes will be opened in a sequential manner (serial number in participant list and serial number mentioned on top of envelope will be the same in all cases) in the presence of the participant and a witness (usually family member of the participant), and intervention allocation will be implemented accordingly.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
The study will be double-blind. Medical staff will be blinded by the random assignment of participants in study groups. The assignment will be performed by a sports physiologist who is not involved in the testing process. Both participants and researchers or outcome assessors are unaware of the assignment of study groups.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2019-11-08, 1398/08/17
-
Ethics committee reference number
-
IR.LUMS.REC.1398.254
2
-
Ethics committee
-
-
Approval date
-
2020-10-06, 1399/07/15
-
Ethics committee reference number
-
IR.LUMS.REC.1399.198
Health conditions studied
1
-
Description of health condition studied
-
Myocardial infarction
-
ICD-10 code
-
I25
-
ICD-10 code description
-
Chronic ischemic heart disease
Primary outcomes
1
-
Description
-
Expression of miR-1
-
Timepoint
-
Before and after the intervention
-
Method of measurement
-
Real time – PCR
2
-
Description
-
C-Reactive Protein (CRP)
-
Timepoint
-
Before and after the intervention
-
Method of measurement
-
by using the immunometric assay technique method and ELISA Kit
3
-
Description
-
Uric acid
-
Timepoint
-
Before and after the intervention
-
Method of measurement
-
by using the immunometric assay technique method and ELISA Kit
4
-
Description
-
Expression of miR-208
-
Timepoint
-
Before and after the intervention
-
Method of measurement
-
Real time – PCR
5
-
Description
-
Expression of miR-133
-
Timepoint
-
Before and after the intervention
-
Method of measurement
-
Real time – PCR
6
-
Description
-
Expression of mRNACapas3
-
Timepoint
-
Before and after the intervention
-
Method of measurement
-
Real time – PCR
7
-
Description
-
CK-mb
-
Timepoint
-
Before and after the intervention
-
Method of measurement
-
by using the immunometric assay technique method and ELISA Kit
8
-
Description
-
Troponin
-
Timepoint
-
Before and after the intervention
-
Method of measurement
-
by using the immunometric assay technique method and ELISA Kit
Secondary outcomes
1
-
Description
-
Quality of Life
-
Timepoint
-
Before and after the intervention
-
Method of measurement
-
Quality of Life Questionnaire
2
-
Description
-
Ejection fraction
-
Timepoint
-
Before and after the intervention
-
Method of measurement
-
Echocardiography and Simpson
3
-
Description
-
Systolic blood pressure
-
Timepoint
-
Before and after the intervention
-
Method of measurement
-
Digital blood pressure device
4
-
Description
-
Maximal Oxygen Consumption (peak VO2)
-
Timepoint
-
Before and after the intervention
-
Method of measurement
-
Exercise stress test
5
-
Description
-
End-systolic volume
-
Timepoint
-
Before and after the intervention
-
Method of measurement
-
M-mode echocardiography
6
-
Description
-
diastolic blood pressure
-
Timepoint
-
Before and after the intervention
-
Method of measurement
-
Digital blood pressure device
7
-
Description
-
End-Diastolic volume
-
Timepoint
-
Before and after the intervention
-
Method of measurement
-
M-mode echocardiography
Intervention groups
1
-
Description
-
Intervention group 1 (HV-HIIT group): A training session on the treadmill at 4 × 4-minute intervals at 90% of HRr with 3 minutes of active recovery at 65% of HRr between intervals and a training session on the bike with 16× 30 seconds intervals with 60 seconds of active recovery at 65% of HRr between intervals , with total exercise of 40 minutes/session.
-
Category
-
Rehabilitation
2
-
Description
-
Intervention group2 (LV-HIIT group): A training session on the treadmill with two 4-minute intervals at an interval intensity of ∼85% HRr with 3 minutes of active recovery at 65% of HRr between intervals and a training session on the bike with 8× 30 seconds intervals with 60 seconds of active recovery at 70% of HRr between intervals, with total exercise of 20 minutes/session
-
Category
-
Rehabilitation
3
-
Description
-
Control group: The control group will receive regular physical exercise recommendations to keep ethical procedures regarding health. In this sense, participants will be advised to participate, without supervision, in at least 30 min of moderate-intensity dynamic aerobic exercise (walking, jogging, cycling, or swimming) 5–7 days per week.
-
Category
-
Rehabilitation
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Khoram-Abad University of Medical Sciences
-
Proportion provided by this source
-
50
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Yes - There is a plan to make this available
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
Yes - There is a plan to make this available
-
Data Dictionary
-
Yes - There is a plan to make this available
-
Title and more details about the data/document
-
Some of the data on the main outcome can be shared after people are not identified.
-
When the data will become available and for how long
-
Starting available 6 months after the publication of results
-
To whom data/document is available
-
Only for researchers working in academic and scientific institutions will be available.
-
Under which criteria data/document could be used
-
Only for meta-analysis research
-
From where data/document is obtainable
-
Dr. Mostafa Cheraghi.,Cardiovascular Research Center.,Lorestan University of Medical Sciences.
-
What processes are involved for a request to access data/document
-
Written and co-ordination of the organs of the Cardiovascular Research Center, Lorestan University of Medical Sciences
-
Comments
-