Protocol summary

Study aim
The purpose of this study was to compare the effects of 8 weeks high-intensity-interval-training versus moderate-intensity-aerobic-continuous-training on a predictive factor of heart-failure in sedentary postmenopausal women.
Design
randomized trail, one control group with two exercise groups with sample size of 30 individual with simple randomisation, enrolled between 2016 and 2017.
Settings and conduct
In this study, 30 healthy sedentary postmenopausal women were selected in Isfahan and the subjects were randomly divided into three groups high intensity interval training, moderate-intensity aerobic continuous training and control. The high intensity interval training group participated in an exercise program at 60–90% of heart rate reserve and the moderate-intensity aerobic continuous training group participated in an exercise program at 50–65% of heart rate reserve but the control group did not participate in any regular physical activity program during this period.
Participants/Inclusion and exclusion criteria
Inclusion criteria: participants were 46 ≥age≤ 65 years; with regular eating patterns; healthy; living in Isfahan Exclusion criteria: history of Heart Failure; hypertension; kidney disease; diabetes (type 2); history of cancer ; history of hyperlipidemia
Intervention groups
Intervention group 1:High Intensity Interval Training Intervention group 2: Moderate Intensity Aerobic Continuous Training Control group: Without training
Main outcome variables
some cardiovascular factors and lipid profiles were compared before and after 8 weeks in three groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190618043929N1
Registration date: 2019-09-15, 1398/06/24
Registration timing: retrospective

Last update: 2019-09-15, 1398/06/24
Update count: 0
Registration date
2019-09-15, 1398/06/24
Registrant information
Name
Diana keyhani
Name of organization / entity
The University of Urmia
Country
Iran (Islamic Republic of)
Phone
+98 31 3237 3306
Email address
keyhanid1368@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
2016-12-22, 1395/10/02
Actual recruitment end date
2017-02-20, 1395/12/02
Trial completion date
2017-04-05, 1396/01/16
Scientific title
Comparison of the effect of 8 weeks High intensity interval training and Moderate-intensity aerobic continuous training on prevention of cardiovascular diseases in postmenopausal women
Public title
Effect of exercise in cardiovascular diseases
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
participants were 46 ≥age≤ 65 years; with regular eating patterns; healthy; living in Isfahan
Exclusion criteria:
history of Heart Failure; hypertension; kidney disease; diabetes (type 2); history of cancer; history of hyperlipidemia
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Random Sampling
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sport Sciences Research Institute of Iran
Street address
No. 3.5 St., MirEmad St., Motahari Ave., Tehran., Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2016-10-31, 1395/08/10
Ethics committee reference number
IR.SSRI.REC.1395.113

Health conditions studied

1

Description of health condition studied
Heart Failure
ICD-10 code
I50
ICD-10 code description
Heart failure

Primary outcomes

1

Description
cardiovascular biomarkers
Timepoint
before and after intervention
Method of measurement
blood sample

Secondary outcomes

1

Description
lipid profile
Timepoint
before and after intervention
Method of measurement
blood sample

Intervention groups

1

Description
First intervention group: 8 weeks intensity interval training
Category
N/A

2

Description
Second intervention group: 8 weeks moderate-intensity aerobic continuous training
Category
N/A

3

Description
Control group: any regular physical activity program
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan University
Full name of responsible person
Navid sedri
Street address
Hezarjrib St., Isfahan University
City
Isfahan
Province
Isfehan
Postal code
8176755133
Phone
+98 31 3234 5189
Email
navidsedri@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Urmia
Full name of responsible person
Bakhtyar Tartibian
Street address
Urmia University,. Nazloo Ave, Urmia University
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 44 3275 2840
Email
info@urmia.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Urmia
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Urmia
Full name of responsible person
Diana Keyhani
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. 10, No. 158, Ordibehesht Jonoobi St.
City
Isfahan
Province
Isfehan
Postal code
8134935471
Phone
+98 31 3237 3306
Email
keyhanid1368@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Urmia
Full name of responsible person
Diana Keyhani
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. 10, No. 158, Ordibehesh Jonoobi St.
City
Isfahan
Province
Isfehan
Postal code
8134935471
Phone
+98 31 3237 3306
Email
keyhanid1368@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Urmia
Full name of responsible person
Diana Keyhani
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. 10, No. 158, Ordibehesht Jonoobi St.
City
Isfahan
Province
Isfehan
Postal code
8134935471
Phone
+98 31 3237 3306
Email
keyhanid1368@gmail.com

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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The main results of the study
When the data will become available and for how long
One year after the publication of the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
More detailed studies in this field
From where data/document is obtainable
Diana Keyhani keyhanid1368@gmail.com
What processes are involved for a request to access data/document
8 weeks
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