Protocol summary

Study aim
The effect of three different training programme with and without blood flow restriction on hypertrophy, sarcopenia and functional performance in elderly women
Design
In this study, 40 healthy elderly women were selected based on inclusion criteria and randomly divided into 4 groups (3 training group and 1 control).
Settings and conduct
The study will be conducted in a gym in Mashad. The subjects will train three session per week for 10 weeks under the supervision of an experienced trainer. Pre-test and post-test will perform blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range from 60 to 70 yr., lack of regular physical activity or exercise training, lack of medication, lack of orthopedic problems
Intervention groups
The intervention groups are included: 1- strength training with vascular occlusion (strength training in upper and lower extremities under condition that proximal portion of the arms and leg were occluded with elastic band), 2- strength training without vascular occlusion (typical strength training, 4 sets with repetition of 30,15,15,15), 3- hypertrophic strength training (traditional strength training, 4 sets with repetition of 8-12), 4- control (lack of any regular exercise training or physical activity)
Main outcome variables
Plasma level of CAF and P3NP, Muscle strength and endurance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171027037031N1
Registration date: 2018-04-15, 1397/01/26
Registration timing: retrospective

Last update: 2018-04-15, 1397/01/26
Update count: 0
Registration date
2018-04-15, 1397/01/26
Registrant information
Name
Akram Sharifi Moghadam
Name of organization / entity
Hakim Sabzevari University
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 2750
Email address
a.sharifimoghadam@hsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of three different resistance training program with and without blood flow restriction on some indices of hypertrophy, sarcopenia and physical function in elderly women
Public title
the effect of exercise training on muscle strength and endurance in elderly women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
elderly women no CVD, diabetes, epilepsy, cancer no orthopedic problems no medication
Exclusion criteria:
hypertension
Age
From 60 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
we will assign number to each subjects and will use table of random numbers
Blinding (investigator's opinion)
Single blinded
Blinding description
The subjects, testers and statistics specialist will blind about the grouping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Deputy of Research and Technology،Next to the road police،Sabzevar University of Medical Sciences
City
sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2017-11-06, 1396/08/15
Ethics committee reference number
IR.Medsab.1396.97

Health conditions studied

1

Description of health condition studied
aging
ICD-10 code
R54
ICD-10 code description
Age-related physical debility

Primary outcomes

1

Description
Plasma concentration of CAF that is measured using ELISA kit
Timepoint
Before and after 10 weeks exercise training
Method of measurement
ELISA commercial kit

2

Description
Plasma concentration of P3NP that is measured using ELISA kit
Timepoint
Before and after 10 weeks exercise training
Method of measurement
ELISA commercial kit

3

Description
muscle strength
Timepoint
Before and after 10 weeks exercise training
Method of measurement
Using hand grip dynamometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: exercise training
Category
Rehabilitation

2

Description
Control group: daily physical activity, no exercise training
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Hakim Sabzevari University
Full name of responsible person
Akram Sharifi Moghadam
Street address
Hakim Univ. Tohid Shahr, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2755
Fax
+98 51 4401 2755
Email
a.sharifimoghadam@hsu.ac.ir
Web page address
https://www.hsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Dr. Mohammadreza Hamedinia
Street address
Tohid Shahr
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2750
Fax
+98 51 4401 2750
Email
a.sharifimoghadam@hsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hakim Sabzevari University
Proportion provided by this source
100
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
HakimSabzevari University
Full name of responsible person
Dr. Mohammadreza Hamedinia
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Tohod Shahr
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2750
Fax
+98 51 4401 2750
Email
mrhamedi1350@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Dr. Mohammadreza Hamedinia
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Tohid Shahr
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2750
Email
mrhamedi1350@gmail.com
Web page address
http://www.hsu.ac.ir/sport/

Person responsible for updating data

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Akram Sharifi Moghadam
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Tohid Shahr
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2750
Fax
+98 51 4401 2750
Email
a.sharifimoghadam@hsu.ac.ir
Web page address
http://www.hsu.ac.ir/sport/

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
No more information available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The inform consent will be submitted as an attachment to the thesis
When the data will become available and for how long
The data will be unlimited available after paper publication
To whom data/document is available
All people have access to the data.
Under which criteria data/document could be used
There is no limit to data access.
From where data/document is obtainable
To receive the data, one has to contact supervisor
What processes are involved for a request to access data/document
The request must be submitted to the supervisor by email and the data will be available within a maximum of one week
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