Protocol summary

Study aim
Design, implementation and evaluation of physical activity educational application in the elderly women in Isfahan.
Design
Clinical trial with intervention and control group, simple random method, sample size 76
Settings and conduct
This semi-experimental study with two control and intervention groups will be conducted on 76 elderly women who are members of the retired education center in Isfahan city .The educational intervention will be carried out for 2 months. In this way, the educational application will be available to people for 8 weeks and 3 sessions per week to perform sports. Then, immediately after the intervention, participants' sharky physical activity questionnaire will be completed in both the control and intervention groups, and the application quality assessment standard questionnaire will be completed in the intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria : 1)All women between the ages of 60 and 65 2)Ability to exercise 3)Not having a physical or mental illness such as (cardiovascular disease, blood pressure, diabetes, acute joint problems, osteoporosis, respiratory problems, Alzheimer's) or any special disease that may endanger a person's health by exercising 4)Having a smartphone and the ability to use educational software 5)Interested in participating in the study 6)Having a doctor's approval to enter the study 7)Having a written consent to participate in the study Exit criteria: 1)Unwillingness to continue participating in the study 2)The development of physical and mental illness during the study
Intervention groups
The intervention will be carried out through an educational application for 8 weeks and 3 sessions per week to perform sports movements. The control group will not receive Education.
Main outcome variables
Average physical activity score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230717058823N1
Registration date: 2023-07-22, 1402/04/31
Registration timing: prospective

Last update: 2023-07-22, 1402/04/31
Update count: 0
Registration date
2023-07-22, 1402/04/31
Registrant information
Name
Zahra Morshedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5752 2252
Email address
zahra.morshedib1374@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-06, 1402/06/15
Expected recruitment end date
2023-11-06, 1402/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation and evaluation of physical activity educational application in the elderly women
Public title
Design, implementation and evaluation of physical activity educational application
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All women between the ages of 60 and 65 Ability to exercise Not having a physical or mental illness such as (cardiovascular disease, blood pressure, diabetes, acute joint problems, osteoporosis, respiratory problems, Alzheimer's) or any special disease that may endanger a person's health by exercising Having a smartphone and the ability to use educational software Interested in participating in the study Having a doctor's approval to enter the study Having a written consent to participate in the study
Exclusion criteria:
Unwillingness to continue participating in the study The development of physical and mental illness during the study
Age
From 60 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling of this research will be done systematically. In this way, the desired number of samples will be selected from the Isfahan Center for Education Retirees by systematic sampling and according to the informed consent and doctor's approval, the entry criteria as well as the calculated sample size .At the end, people will be divided into two control and intervention groups by random allocation method.
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
Ethical Committee of Isfahan University of Medical Sciences
Street address
Research and Technology Vice-Chancellor, Building No. 4,Isfahan University of Medical Sciences and Health Care Services, Hazar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2023-05-08, 1402/02/18
Ethics committee reference number
IR.MUI.RESEARCH.REC.1402.043

Health conditions studied

1

Description of health condition studied
Physical activity of elderly women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Average physical activity score
Timepoint
Before the intervention, the end of the intervention
Method of measurement
Sharkey physical activity questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
At the beginning of the study, the sharky physical activity questionnaire will be completed by the participants in two groups, then the educational application will be provided to the intervention group, and after the intervention again, the sharky physical activity questionnaire will be completed by the participants in the intervention group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Education Retired Center
Full name of responsible person
Mr. Amir Poyanfar
Street address
First Palestine Street, Palestine Square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
1863 - 81465
Phone
+98 31 3222 0013
Email
kanonbaz@isfedu.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shahin Shirani
Street address
Isfahan University of Medical Sciences and Health Services, Hazar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 9500
Email
massoumigh@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Asiyeh Pirzadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Health, Isfahan University of Medical Sciences and Health Services, Hazar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3340
Email
as_pirzadeh@hlth.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Asiyeh Pirzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Health, Isfahan University of Medical Sciences and Health Services, Hazar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3340
Email
as_pirzadeh@hlth.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Asiyeh Pirzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Health, Isfahan University of Medical Sciences and Health Services, Hazar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3340
Email
as_pirzadeh@hlth.mui.ac.ir

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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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