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General information
40
50
4050
empty
40
40
2020-11-21, 1399/09/01
2021-01-20, 1399/11/01
20202021-1101-2120 00:00:00
2020-12-20, 1399/09/30
2021-03-20, 1399/12/30
20202021-1203-20 00:00:00
empty
2021-04-09, 1400/01/20
2021-04-09 00:00:00
empty
2021-04-19, 1400/01/30
2021-04-19 00:00:00
empty
2021-08-22, 1400/05/31
2021-08-22 00:00:00
empty
Adding the actual recruitment date and changing the registration to "Prospective"
Adding the actual recruitment date and changing the registration to "Prospective"
empty
افزودن تاریخ بیمار گیری حقیقی و تغییر ثبت به حالت آینده نگر
افزودن تاریخ بیمار گیری حقیقی و تغییر ثبت به حالت آینده نگر
Recruitment centers
#1
Name of recruitment center - English: Daily Soroush Elderly Care Center
Name of recruitment center - Persian: مرکز روزانه مراقبت سالمندان سروش
Full name of responsible person - English: Tahereh Sokot
Full name of responsible person - Persian: طاهره سکوت
Street address - English: No 30, Mirza Shirazi Blvd,Shiraz
Street address - Persian: شیراز - بلوار میرزای شیرازی - پلاک 30
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7196844938
Phone: +98 71 3625 0306
Fax:
Email: bonyadfarzaneganehfarhikhtehshz@gmail.com
Web page address:
Name of recruitment center - English: Soroush Elderly Care Center
Name of recruitment center - Persian: مرکز مراقبت سالمندان سروش
Full name of responsible person - English: Tahereh Sokot
Full name of responsible person - Persian: طاهره سکوت
Street address - English: No 30, Mirza Shirazi Blvd, Shiraz
Street address - Persian: شیراز، بلوار میرزای شیرازی، پلاک 30
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7196844938
Phone: +98 71 3625 0306
Fax:
Email: bonyadfarzaneganehfarhikhtehshz@gmail.com
Web page address:
Name of recruitment center - English: Daily Soroush Elderly Care Center Name of recruitment center - Persian: مرکز روزانه مراقبت سالمندان سروش Full name of responsible person - English: Tahereh Sokot Full name of responsible person - Persian: طاهره سکوت Street address - English: No 30, Mirza Shirazi Blvd,ShirazBlvd, Shiraz Street address - Persian: شیراز -، بلوار میرزای شیرازی -، پلاک 30 City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7196844938 Phone: +98 71 3625 0306 Fax: Email: bonyadfarzaneganehfarhikhtehshz@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: The univetsity of Shiraz
Name of organization / entity - Persian: دانشگاه شیراز
Full name of responsible person - English: Farhad Daryanoosh
Full name of responsible person - Persian: فرهاد دریانوش
Street address - English: Eram sq,Shiraz University
Street address - Persian: میدان ارم، دانشگاه شیراز
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: ۸۴۳۳۴ - ۷۱۹۴۶
Phone: +98 71 3647 4408
Fax:
Email: webadmin@shirazu.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: The univetsity of Shiraz
Name of organization / entity - Persian: دانشگاه شیراز
Full name of responsible person - English: Farhad Daryanoosh
Full name of responsible person - Persian: فرهاد دریانوش
Street address - English: Eram sq, Shiraz University
Street address - Persian: میدان ارم، دانشگاه شیراز
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7194684334
Phone: +98 71 3647 4408
Fax:
Email: webadmin@shirazu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: The univetsity of Shiraz Name of organization / entity - Persian: دانشگاه شیراز Full name of responsible person - English: Farhad Daryanoosh Full name of responsible person - Persian: فرهاد دریانوش Street address - English: Eram sq,Shirazsq, Shiraz University Street address - Persian: میدان ارم، دانشگاه شیراز City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: ۸۴۳۳۴ - ۷۱۹۴۶7194684334 Phone: +98 71 3647 4408 Fax: Email: webadmin@shirazu.ac.ir Web page address:
Protocol summary
Study aim
Evaluation of the effect of resistance training protocol and comparison of detraining and two types of maintenance training protocols on serum levels of IGF-1, MSTN and some functional factors in sarcopenic elderly women
Design
Forty sarcopenic elderly women are randomly divided into two groups: resistance training (n = 30) and control (n = 10). After performing the intervention at the end of week 8, the training group is randomly divided into three groups: maintenance training 1 (10 people), maintenance training 2 (10 people) and detraining group (10 people). Then, the maintenance training protocol is performed at a dose lower than the initial dose and its effect on maintaining the adaptations resulting from resistance training at the end of week 12 is investigated.
Settings and conduct
Resistance training will be done in the gym of Shiraz University Sports Center located on Saheli Street.
Participants/Inclusion and exclusion criteria
Older women over 60 years who have a muscle mass index of less than 6.76 kg / m2, grip strength of less than 20 kg and a speed of less than 8 m / s, and do not have severe musculoskeletal abnormalities or hypertension.
Intervention groups
Stage 1: Resistance Training and Control Group
Stage 2: Maintenance Training Group 1, Maintenance Training Group 2, detraining Group and Control Group
Main outcome variables
Insulin-like growth factor-1, myostatin, muscle cross-section, muscle thickness, hand grip strength, gait speed, maximum dynamic strength, maximum oxygen consumption
General information
Reason for update
Adding the actual recruitment date and changing the registration to "Prospective"
Acronym
IRCT registration information
IRCT registration number:IRCT20200828048549N1
Registration date:2021-04-04, 1400/01/15
Registration timing:prospective
Last update:2022-07-13, 1401/04/22
Update count:1
Registration date
2021-04-04, 1400/01/15
Registrant information
Name
Zeinab Hooshmandi
Name of organization / entity
The University of Payame Noor
Country
Iran (Islamic Republic of)
Phone
+98 71 3225 5090
Email address
z_hoshmandi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
2021-04-09, 1400/01/20
Actual recruitment end date
2021-04-19, 1400/01/30
Trial completion date
2021-08-22, 1400/05/31
Scientific title
The effect of resistance training, detraining and maintenance training on Catabolic, Anabolic and Functional factors in elderly women
Public title
The effect of resistance training on elderly women muscles
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Muscle mass less than 6.76 kg/m2 measured by Bioelectrical Impedance Analysis
Muscle strength less than 20 kg
Walking speed less than 0.8 m/s
Age more than 60 years
no experience in resistance training
Exclusion criteria:
Musculoskeletal abnormalities
Stroke
sever Hypertention
alzheimer and Parkinson disease
Age
From 60 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done with the balanced block method and 4 blocks will be used. Subjects will be placed in these blocks in order of entering the study and each patient randomly will be assigned to the study groups.
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 Shiraz University of Medical Sciences
Intervention group: Resistance Training: The 8-week training protocol includes 2 mesocycles. The first mesocycle, 2 weeks (6 sessions / 3 sessions per week / 2 to 4 sets, repetitions 8 to 15 and each session includes 8 training movements) and the second mesocycle, 6 weeks strength protocol (18 sessions / 3 sessions per week / 2 to 3 sets, 4 to 6 repetitions, 20 minutes of recovery, 2 repetitions in fatigue, 20 minutes of recovery and 1 or 2 repetitions until reaching helplessness and each session includes 8 training movements). At the beginning and end of the session, warm up for 5 minutes and cool down for 5 minutes with low intensity using movements such as walking, jogging and light stretching exercises. A training session lasts approximately 35 minutes. In this study, in order to comply with the principle of overload, the workload will increase by 5-10% on a weekly basis in proportion to the ability of the subjects.
Category
Treatment - Other
2
Description
Intervention group: Maintenance Training 1: The 8-week training protocol includes 2 mesocycles. The first mesocycle, 2 weeks (6 sessions / 2 sessions per week / 2 to 4 sets, repetitions 8 to 15 and each session includes 8 training movements) and the second mesocycle, 6 weeks strength protocol (18 sessions / 3 sessions per week / 2 to 3 sets, 4 to 6 repetitions, 20 minutes of recovery, 2 repetitions in fatigue, 20 minutes of recovery and 1 or 2 repetitions until reaching helplessness and each session includes 8 training movements). At the beginning and end of the session, warm up for 5 minutes and cool down for 5 minutes with low intensity using movements such as walking, jogging and light stretching exercises. A training session lasts approximately 35 minutes. In this study, in order to comply with the principle of overload, the workload will increase by 5-10% on a weekly basis in proportion to the ability of the subjects.
Category
Treatment - Other
3
Description
Intervention group: Maintenance Training 2: The 8-week training protocol includes 2 mesocycles. The first mesocycle, 2 weeks (6 sessions / 1 session per week / 2 to 4 sets, repetitions 8 to 15 and each session includes 8 training movements) and the second mesocycle, 6 weeks strength protocol (18 sessions / 3 sessions per week / 2 to 3 sets, 4 to 6 repetitions, 20 minutes of recovery, 2 repetitions in fatigue, 20 minutes of recovery and 1 or 2 repetitions until reaching helplessness and each session includes 8 training movements). At the beginning and end of the session, warm up for 5 minutes and cool down for 5 minutes with low intensity using movements such as walking, jogging and light stretching exercises. A training session lasts approximately 35 minutes. In this study, in order to comply with the principle of overload, the workload will increase by 5-10% on a weekly basis in proportion to the ability of the subjects.
Category
Treatment - Other
4
Description
Intervention group: detraining: They will leave the training for 4 weeks and will have no activities other than normal daily activities.
Category
Treatment - Other
5
Description
Control group: Control
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Soroush Elderly Care Center
Full name of responsible person
Tahereh Sokot
Street address
No 30, Mirza Shirazi Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7196844938
Phone
+98 71 3625 0306
Email
bonyadfarzaneganehfarhikhtehshz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The univetsity of Shiraz
Full name of responsible person
Farhad Daryanoosh
Street address
Eram sq, Shiraz University
City
Shiraz
Province
Fars
Postal code
7194684334
Phone
+98 71 3647 4408
Email
webadmin@shirazu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zeinab Hooshmandi
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 Shiraz
Full name of responsible person
Zeinab Hooshmandi
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Resistance training rehabilitation
Street address
Eram sq, Shiraz university
City
Shiraz
Province
Fars
Postal code
۸۴۳۳۴ - ۷۱۹۴۶
Phone
+98 71 3647 4408
Email
z_hoshmandi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Shiraz
Full name of responsible person
Zeinab Hooshmandi
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Resistance training Rehabilitation and Aging
Street address
Eram sq, Shiraz university
City
Shiraz
Province
Fars
Postal code
7194684334
Phone
+98 71 3647 4408
Email
z_hoshmandi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Shiraz
Full name of responsible person
Zeinab Hooshmandi
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Eram sq
City
Shiraz
Province
Fars
Postal code
7194684334
Phone
+98 71 3647 4408
Email
z_hoshmandi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the average of all data will be published.
When the data will become available and for how long
Access starts 12 months after the publication of results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Mentioning the name of the researcher of this study, the use of data is allowed.
What processes are involved for a request to access data/document
Access to the data will be possible one month after submitting the application and subject to the terms of use of the data.
Comments
Researchers who apply to use the data are only allowed to use the general average of the data, and mentioning the names of the main researchers in preparing the data of this research (Zeinab Hooshmandi and Farhad Darianush) is one of the conditions for using the data.