Effects of Concurrent Training Order on Physical Fitness, Functional Capacity, serum concentrations of Myostatin and Follistatin in Postmenopausal Females.
Investigating the effects of Concurrent Training Order on Physical Fitness, Functional Capacity, serum concentrations of Myostatin and Follistatin in Postmenopausal Females
Design
Randomized clinical trial of 33 women 50-60 years in two parallel group
Settings and conduct
Exercises will be performed in the gym for two months. Participants will be randomly divided into two groups and do the same exercise in different aerobic and resistance orders. The first group will first perform aerobic training and then resistance exercise. However, the second group will first perform resistance training and then perform aerobic training. The intensity of aerobic training would increase from 65 to 80 percent of maximum heart rate, and the intensity of resistance training will be determined by 10 to 12 repetitions, equivalent to 60 to 70 percent of a maximum repetition.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Menopause at age 50 to 60 years, Exclusion criteria: Illness and physical injury
Intervention groups
First intervention: Concurrent Exercises with Resistance-Aerobic Order
Second intervention: Concurrent Exercise with Aerobic-Resistance Order
Main outcome variables
Serum Levels of Myostatin and Folistatin, muscle strength and endurance of Upper and lower body
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200126046267N1
Registration date:2020-03-16, 1398/12/26
Registration timing:retrospective
Last update:2020-03-16, 1398/12/26
Update count:0
Registration date
2020-03-16, 1398/12/26
Registrant information
Name
Leila Esazadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3225 3317
Email address
lesazadeh93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-04, 1398/03/14
Expected recruitment end date
2019-06-19, 1398/03/29
Actual recruitment start date
2019-06-04, 1398/03/14
Actual recruitment end date
2019-06-19, 1398/03/29
Trial completion date
2019-08-20, 1398/05/29
Scientific title
Effects of Concurrent Training Order on Physical Fitness, Functional Capacity, serum concentrations of Myostatin and Follistatin in Postmenopausal Females.
Public title
Effects of Concurrent Training
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Physical Health
At least one year must be passed after Postmenopausal period
Obtain a physical health certificate from a physician
Complete an informed consent form on how to perform the exercises
Lack of exercising in the past six months
Exclusion criteria:
Postmenopausal period Less than a year
Have pain and physical injury
Have heart disease, diabetes, etc.
Take drugs, cigarettes, alcohol
Age
From 50 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
33
Actual sample size reached:
33
Randomization (investigator's opinion)
Randomized
Randomization description
Use random number table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Intervention type was exercise training program.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Neyshabour Azad University
Street address
Research Boulevard, Neyshabour Islamic Azad University Complex
City
Neyshabour
Province
Razavi Khorasan
Postal code
۹۳۱۹۹۷۵۸۵۳
Approval date
2019-01-23, 1397/11/03
Ethics committee reference number
IR.IAU.NEYSHABUR.REC.1397.021
Health conditions studied
1
Description of health condition studied
sarcopenia
ICD-10 code
M62.5
ICD-10 code description
Muscle loss and atrophy, not elsewhere classified Disuse atrophy NEC, Sarcopenia
Primary outcomes
1
Description
Serum Myostatin concentration
Timepoint
Before and after two months of exercise training intervention
Method of measurement
blood sampling from anterior venous arm for use in ELISA Test
2
Description
Serum Follistatin concentration
Timepoint
Before and after two months of exercise training intervention
Method of measurement
blood sampling from anterior venous arm for use in ELISA Test
3
Description
Upper body strength and endurance
Timepoint
Before and after two months of exercise training intervention
Method of measurement
Count the number of correct performances with device the chest press
4
Description
Lower body body strength and endurance
Timepoint
Before and after two months of exercise training intervention
Method of measurement
Counting the number of correct performances lying with the back of the thigh device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Concurrent Training Order (Resistance-Aerobic). In this order, first subjects perform resistance training at eight bodybuilding stations, then after ten minutes of rest, they do aerobic exercises for 30 to 45 minutes.
Category
Prevention
2
Description
Intervention group 2: Concurrent Training Order is (Aerobic-Resistance). In this order, first subjects perform aerobic exercises for 30 to 45 minutes, then after ten minutes of rest, They do resistance training at eight bodybuilding stations.
Category
Prevention
3
Description
Control group:This group does not perform any exercise.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University of Neyshabour Branch
Full name of responsible person
Khajeie Rambod
Street address
Pajohesh Blvd
City
Neishabur
Province
Razavi Khorasan
Postal code
۹۳۱۹۹۷۵۸۵۳
Phone
+98 51 4262 1901
Email
R.khajeie@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Khajeie Rambod
Street address
Pajohesh Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۳۱۹۹۷۵۸۵۳
Phone
+98 51 4262 1901
Email
R.khajeie@gmail.com
Web page address
Grant name
not use
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
university
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Esazadeh Leila
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 37,Tarbiat Alley,Behjat 29,Railway Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9144844535
Phone
+98 51 3225 3317
Email
lesazadeh93@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Esazadeh Leila
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 37,Tarbiat Alley,Behjat 29,Railway Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9144844535
Phone
+98 51 3225 3317
Email
lesazadeh93@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Esazadeh Leila
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 37,Tarbiat Alley,Behjat 29,Railway Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9144844535
Phone
+98 51 3225 3317
Email
lesazadeh93@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
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
The collected blood markers information can be shared
When the data will become available and for how long
After publishing the article in a prestigious journal since 1999
To whom data/document is available
Editor of Research Journal
Under which criteria data/document could be used
In order to ensure the accuracy of information
From where data/document is obtainable
Editor of Research Journal
What processes are involved for a request to access data/document
Presenting scientific reasons to the editor of the journal Scientific Research
Comments
Information will be delivered without the names of the subjects