Protocol summary

Summary
This study examines the impact of an educational intervention on self-efficacy and stages of change related to physical activity and sleep quality in older men in Shiraz, Iran. Methods: This study is a randomized controlled trial of training on 74 subjects aged 60-75years old that have the ability to exercise is as a inclusion criteria and neurological disease that impact on the quality of sleep is one of the exclusion criteria. Elderly are assigned into two experimental and control groups and intervention group, will receive appropriate intervention. Questionnaire, as a measurement tool, completion for a week before and one month after intervention and the results will be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201401057816N2
Registration date: 2014-02-21, 1392/12/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-02-21, 1392/12/02
Registrant information
Name
Mahin Nazari
Name of organization / entity
School of health
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
manazari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences - Vice chancellor for Research and Technology
Expected recruitment start date
2013-11-01, 1392/08/10
Expected recruitment end date
2014-01-20, 1392/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of educational intervention on stages of change & self-efficacy related physical Exercise & Sleep Quality in Elderly Men In Shiraz.
Public title
The Effect of educational intervention on stages of change & self-efficacy related physical Exercise & Sleep Quality in Elderly Men In Shiraz.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 60-75 years old; able to exercise & walking; having literacy. Exclusion criteria: having medical problem; use of sleep drugs; having absenteeism more than one sessions.
Age
From 60 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
Street address
Shiraz University Of Medical Sciences, Zand Ave. , Shiraz, Iran
City
shiraz
Postal code
Approval date
2013-10-23, 1392/08/01
Ethics committee reference number
CT-92-6817

Health conditions studied

1

Description of health condition studied
sleep quality
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified

Primary outcomes

1

Description
Preventional behaviors
Timepoint
One week before intervention- one month after intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: education of this group will be 6 sessions & per session to time 1 hour for sleep quality & physical activity improvement /
Category
Behavior

2

Description
control group: In control group was not intervention performed.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Jahandideh Club
Full name of responsible person
the general bureau welfara of fars
Street address
Shiraz Jahandideh Club, Kholdebarin Park
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Gholamreza Hatam
Street address
Shiraz University Of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Public Health
Full name of responsible person
Motafa Taheri
Position
MSc. student of health education
Other areas of specialty/work
Street address
Department of health education & promotion, School of health , Shiraz University of Mediccal Sciences
City
Shiraz
Postal code
7153675541
Phone
+98 71 1725 1006
Fax
+98 71 1726 0225
Email
taheri_hp90@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Public Health
Full name of responsible person
Mahin Nazari
Position
Assistant professor
Other areas of specialty/work
Street address
Department of health education & promotion, School of health , Shiraz University of Mediccal Sciences
City
Shiraz
Postal code
7153675541
Phone
+98 71 1725 1006
Fax
+98 71 1726 0225
Email
manazari@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Public Health
Full name of responsible person
Mahin Nazari
Position
Assistant professor
Other areas of specialty/work
Street address
Department of health education & promotion, School of health , Shiraz University of Mediccal Sciences
City
Shiraz
Postal code
7153675541
Phone
+98 71 1725 1006
Fax
+98 71 1726 0225
Email
manazari@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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