Comparison of high-intensity interval training and moderate-intensity continuous training models on cardiac rehabilitation indices and electrical activity after coronary artery bypass surgery
Comparison of high-intensity and moderate-intensity continuous training models on rehabilitation of cardiac patients after coronary artery bypass surgery
Design
clinical trial with control group , with parallel group, single-blind, randomized with computer and on 18 patients
Settings and conduct
This study is performed in the heart clinics of Shiraz in Iran by selecting the three groups that mentioned. After selection, patients will be examined by electrocardiography and cardiac stress test and will be engaged in exercises for 6 weeks, and then electrocardiography and exercise test will be repeated. .
Participants/Inclusion and exclusion criteria
Male and female gender, sinus rhythm, left ventricular ejection fraction 50% or higher, and 4 to 16 weeks after CABG
Intervention groups
The study will consist of three groups, two groups under the intervention of exercise program under two protocols:
MICE protocol, (Moderate intensity continuous training) Includes 3 sessions of 45-minute workouts with an intensity of 70% of the heart rate reserve in each week. it s done for 6 weeks. At the beginning and end of each training session, the patient will warm up and cool down
HIIT protocol ( high intensity interval training)
Warm up
9 time repetition of 2-minute training with an intensity of 90-85% of the heart rate reserve and with an active rest period of 2 minutes between them
with Intensity of 70-60% of stored heart rate
cool down
Control group
They will be selected from those who do not do a cardiac rehabilitation exercise program
Main outcome variables
Main out come variables consists:
Heart rate variability (HRV); QT interval in electrocardiogram; T wave alternans in electrocardiogram; VO2PEAK
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220326054352N1
Registration date:2022-03-31, 1401/01/11
Registration timing:prospective
Last update:2022-03-31, 1401/01/11
Update count:0
Registration date
2022-03-31, 1401/01/11
Registrant information
Name
Emad Jowharishirazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 6693
Email address
emad.jsh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of high-intensity interval training and moderate-intensity continuous training models on cardiac rehabilitation indices and electrical activity after coronary artery bypass surgery
Public title
Comparison of high and moderate intensity cardiac rehabilitation after CABG
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female gender,
sinus rhythm,
EF 50% or higher
and 4 to 16 weeks after CABG
Exclusion criteria:
Includes peripheral vascular disease,
valvular disease,
PVC PAC RYTHM,
conduction defects
diabetes,
160/90 mm Hg,
limited neurological featuresAnd orthopedics related to exercise,
discontinuation of medication during the study
Age
From 35 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method will be such that the study population is from one of the most busiest heart clinics in Shiraz and patients should refer to it after surgery. then the subjects will be divided into 4 groups, based on women between 35 and 50, men between 35 and 50, men between 50 and 60, and women between 50 and 60. Then, 4 people will be selected by simple classified sampling for each group . then, one person will be selected from that four participant for each of the sports protocol groups randomly and through a lottery by unknown balls. Two people will also join the control group. Obviously, the randomization unit is individual. Classified randomization will be done after determining the groups by Excel software. the results of the lottery, which will be based on the protocol and control groups and the personnel code, will be given to the participants in an sealed envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
data analyser will be blind with coding the data
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Vo2peak(maximum oxygen uptake)
Timepoint
before and after intervention
Method of measurement
indirectly by cardiac stress test
2
Description
Heart rate variability
Timepoint
before and after intervention
Method of measurement
Electrocardiography
3
Description
QT interval
Timepoint
before and after intervention
Method of measurement
Electrocardiography
4
Description
T wave alternans
Timepoint
before and after intervention
Method of measurement
Electrocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:1:"MICE protocol, (Moderate intensity continuous training) Includes 3 sessions of 45-minute workouts with an intensity of 70% of the heart rate reserve in each week .it s done for 6 weeks. At the beginning and end of each training session, the patient will warm up and cool down for 5 minutes with an intensity of 50-55% of The heart rate reserve
Category
Rehabilitation
2
Description
Intervention group: 2:'' HIIT protocol ( high intensity interval training)Warm up for 5 minutes with an intensity of 60-50% of heart rate reserve2 9 time repetition of 2-minute training with an intensity of 90-85% of the heart rate reserve and with an active rest period of 2 minutes between them with Intensity of 70-60% of stored heart rate5 minutes with an intensity of 60-50% of the heart rate reserve for cooling down
Category
Rehabilitation
3
Description
Control group: No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza clinic
Full name of responsible person
Emad Jowhari Shirazi
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3627 6693
Email
emad.jsh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
DR.Mahtab Meamarpoor
Street address
Shiraz medical university, Zand university
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Emad Jowharishirazi
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
Cardiology
Street address
No,32 49/4Ave ,Ghasroddasht street
City
Shiraz
Province
Fars
Postal code
7183783384
Phone
+98 71 3627 6693
Fax
Email
emad.jsh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Prof. mohammad ali babaee beygi
Position
cardiology professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Cardiovascular group Office of Shiraz University of Medical Sciences, Al-Zahra Hospital, Sibouyeh Blvd
City
Shiraz
Province
Fars
Postal code
5493771649
Phone
+98 71 3739 8811
Fax
Email
m.babaee.med@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Prof. mohammad ali babaee beygi
Position
cardiology professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Cardiovascular group Office of Shiraz University of Medical Sciences, Al-Zahra Hospital, Sibouyeh Blvd
City
Shiraz
Province
Fars
Postal code
5493771649
Phone
+98 71 3739 8811
Fax
Email
m.babaee.med@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available