Protocol summary

Study aim
The aim of this study was to investigate the effect of eight weeks of TRX Suspension Training (TST) on serum levels of neuromuscular growth factors and functional indices in elderly men with sarcopenia.
Design
In this research, a semi-experimental design was used (two groups in the form of a pretest and a post-test). As a result of the coronavirus pandemic, some participants refused to participate in the training protocol. Therefore, those who were willing to participate in the exercise program were assigned to the training group.
Settings and conduct
Before starting the protocol participants were trained how to do the exercises. The training programs included 8 weeks, three sessions per week, about 60 min per session including warm up and cool down. ِDue to the coronavirus pandemic exercises were done outdoors. Serum concentrations of muscle growth markers, anthropometric and body composition indices, and functional tests were evaluated at baseline and after 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria included: 1- age more than 65 years; 2- handgrip strength lower than 32Kg, and SMM/height2 lower than 9.2 kg/m2; 3- being sedentary for at least 1 year (didn’t have more than 1h exercise per week) Exclusion criteria included: 1- cardiovascular or pulmonary diseases, diabetes, Joint and muscle problems, and Mental and cognitive disorders; 2- involvement in any extra exercise training programs; 3- not interested in continuing or changing in personal life schedule.
Intervention groups
Participants in the Control group were asked to continue their routine lifestyle. The training group executed the TRX Suspension Training for 8 weeks.
Main outcome variables
Myostatin levels; Follistatin levels; GDF-15 levels; CAF levels; Handgrip strength; Gait speed; Time up and go (TUG); Chair stand speed; Standing balance.

General information

Reason for update
Acronym
TRX (Total Body Resistance Exercise)
IRCT registration information
IRCT registration number: IRCT20230727058944N1
Registration date: 2023-09-20, 1402/06/29
Registration timing: retrospective

Last update: 2023-09-20, 1402/06/29
Update count: 0
Registration date
2023-09-20, 1402/06/29
Registrant information
Name
Sohrab Rezaei
Name of organization / entity
Allameh Tabataba'i University
Country
Iran (Islamic Republic of)
Phone
+98 21 2291 2865
Email address
sohrabrezaei8968@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-08-15, 1399/05/25
Actual recruitment start date
2020-07-22, 1399/05/01
Actual recruitment end date
2020-08-15, 1399/05/25
Trial completion date
2020-10-26, 1399/08/05
Scientific title
The effects of TRX Suspension Training on sarcopenic neuromuscular markers and functional abilities in elderlies with sarcopenia
Public title
Effect of exercise training on sarcopenia in elderlies
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 65 years Handgrip strength lower than 32Kg SMM/height2 lower than 9.2 kg/m2 Being sedentary for at least 1 year (didn’t have more than 1h exercise per week)
Exclusion criteria:
Cardiovascular or pulmonary diseases, diabetes, Joint and muscle problems, and Mental and cognitive disorders Involvement in any extra exercise training programs Not interested to continue or change in personal life schedule
Age
From 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 23
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committees of Allameh Tabataba'i University
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1489684511
Approval date
2020-01-15, 1398/10/25
Ethics committee reference number
IR.ATU.REC.1399.023

Health conditions studied

1

Description of health condition studied
With aging, there is an inevitable progressive loss of muscle mass and strength called sarcopenia that is associated with the risk of impairment in physical ability which could lead to consequences such as falls, fall-related injuries, hospitalizations, and even mortality.
ICD-10 code
M62.5
ICD-10 code description
Muscle wasting and atrophy, not elsewhere classified

Primary outcomes

1

Description
Myostatin levels
Timepoint
24 hours before intervention and 48 hours after intervention
Method of measurement
Collection of venous blood samples with a syringe and laboratory assessments

2

Description
Follistatin levels
Timepoint
24 hours before intervention and 48 hours after intervention
Method of measurement
Collection of venous blood samples with a syringe and laboratory assessments

3

Description
GDF-15 levels
Timepoint
24 hours before intervention and 48 hours after intervention
Method of measurement
Collection of venous blood samples with a syringe and laboratory assessments

4

Description
CAF levels
Timepoint
24 hours before intervention and 48 hours after intervention
Method of measurement
Collection of venous blood samples with a syringe and laboratory assessments

Secondary outcomes

1

Description
Handgrip strength
Timepoint
24 hours before intervention and 48 hours after intervention
Method of measurement
Jamar hand dynamometer (USA) with five handle positions and the second position was used for all participants.

2

Description
Gait speed
Timepoint
24 hours before intervention and 48 hours after intervention
Method of measurement
Walking speed of participants was assessed using a stopwatch.

3

Description
Time Up and Go (TUG)
Timepoint
24 hours before intervention and 48 hours after intervention
Method of measurement
TUG test was assessed using a stopwatch.

4

Description
Chair stand speed
Timepoint
24 hours before intervention and 48 hours after intervention
Method of measurement
chair stand test was assessed using a stopwatch.

5

Description
Standing balance
Timepoint
24 hours before intervention and 48 hours after intervention
Method of measurement
The standing balance test was assessed using a stopwatch.

Intervention groups

1

Description
Intervention group: TRX training group: Participants were trained for 8 weeks, three sessions per week, and about 60 min per session.
Category
Treatment - Devices

2

Description
Control group: Participants in the Control group were asked to continue their routine lifestyle.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Saraye Zargande
Full name of responsible person
Mohamad Nilforooshzadeh
Street address
Daliri St., Daliri St., Zargandeh.
City
Tehran
Province
Tehran
Postal code
1919843861
Phone
+98 21 2660 2280
Email
sarayezargandeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Research Vice President of Allameh Tabatabai University
Street address
Allameh Tabataba'i University, Dehkadeh-ye-Olympic, Tehran
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 0000
Email
eslami.rasul@gmail.com
Web page address
https://atu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Allameh Tabataba'i University
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
Allameh Tabataba'i University
Full name of responsible person
Rasoul Eslami
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Address: Allameh Tabataba'i University, Varzesh Sq., Dehkadeh Olympic, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
14896845110
Phone
+98 918 366 4507
Email
eslami.rasul@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Sohrab Rezaei
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
No.18, Homayoun St., Dastgerdi St. Shariati Ave.,
City
Tehran
Province
Tehran
Postal code
1919843861
Phone
+98 21 2291 2865
Fax
Email
sohrabrezaei8968@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Sohrab Rezaei
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
No.18, Homayoun St., Dastgerdi St. Shariati Ave.,
City
Tehran
Province
Tehran
Postal code
1919843861
Phone
+98 21 2291 2865
Fax
Email
sohrabrezaei8968@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
All data is shareable after de-identifying individuals.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions and people who work in businesses.
Under which criteria data/document could be used
Any use and analysis of data must be done in coordination with the researcher of this project.
From where data/document is obtainable
Applicants can send their requests to receive data to sohrabrezaei8968@gmail.com.
What processes are involved for a request to access data/document
After sending the request, the person's profile and purpose for receiving the data will be asked, and the documents will be sent after confirmation.
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