Protocol summary

Summary
The aim of this study is to compare the effect of morning and evening walking on the quality of sleep of elderly people of Rafsanjan . The research population includes the old people (above 60 years) that refer to urban health centers. If these people based on the Pittsburgh Sleep Quality Index score of 5 or more will receive 5 are enrolled.The sample size is 25 in each group that is chosen based on the previous studies . Participants in this study will be based on randomly divided into two groups. The first group walking in the morning for 4 weeks, followed by a 4 week washout period will be four weeks afternoon walk. The second group at the same time, walking in the evening for 4 weeks, followed by a 4 week washout period will be four weeks morning walk. Interventions in each group will be 12 weeks. Walking program, including a 5-3 minute warm up, 30 minute walk and is a 5-3 minute cool-down.Sleep quality questionnaire will be completed before and after intervention in both groups and data will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016030826965N1
Registration date: 2016-04-23, 1395/02/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-04-23, 1395/02/04
Registrant information
Name
Fateme Abdoli
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
f.abdoli@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-07-20, 1395/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative investigating of the effect of morning and evening walking on the night sleep quality of elderly Rafsanjan 2015
Public title
Comparative investigating of the effect of morning and evening walking on the night sleep quality of elderly Rafsanjan 2015
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria : More than 60 years old; Volunteered to participate in the study; Obtaining the Pittsburgh Sleep Quality Index score of 5 and above; Completed a written informed consent to participate in the study; Physical ability to do light exercise.Exclusion criteria: Failure to participate in two sports sessions continuously or intermittently in 4 sessions; history of addiction; Regular exercise in months ago.
Age
From 60 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Emam Ali Street, Organization Center of Rafsanajn University of Medical Sciences, Rafsanjan, Iran. Rafsanjan Kerman
City
Rafsanjan
Postal code
7718796755
Approval date
2016-01-19, 1394/10/29
Ethics committee reference number
IR.IR.RUMS.REC.1394.185

Health conditions studied

1

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

Primary outcomes

1

Description
night sleep quality
Timepoint
before and after first and second intervention
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

empty

Intervention groups

1

Description
Group A :first for 4 weeks hiking in the morning, and after a 4-week washout period will be 4 weeks afternoon walk.
Category
Lifestyle

2

Description
Group B:At the same time first for 4 hiking in the afternoon, and after a 4-weeks washout period will be 4 weeks morning walk.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Urban health centers
Full name of responsible person
Esmat Taleghani
Street address
Gomhori Street, Nursing and Midwifery School, Rafsanjan, Iran Rafsanjan
City
Rafsanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammad Reza Mirzaee
Street address
Emam Ali Street, Organization Center of Rafsanajn University of Medical Sciences, Rafsanjan, Iran. Rafsanjan Kerman
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Fateme Abdoli
Position
MS/Faculty Member
Other areas of specialty/work
Street address
Gomhori Street, Nursing and Midwifery School, Rafsanjan, Iran Rafsanjan
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
Email
abdoli_f@yahoo.com/f.abdoli@rums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Fateme Abdoli
Position
MS
Other areas of specialty/work
Street address
Jomhori Street, Nursing and Midwifery School, Rafsanjan
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
Email
abdoli_f@yahoo.com/f.abdoli@rums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Fateme Abdoli
Position
Ms/faculty member
Other areas of specialty/work
Street address
Jomhori Street, Nursing and Midwifery School, Rafsanjan, Iran Rafsanjan
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
Email
abdoli_f@yahoo.com/f.abdoli@rums.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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