Protocol summary

Summary
The purpose of this randomized controlled clinical trial is to determine the effect of walking using pedometer on depression and general heath of post menopausal women.in this study 106 postmenopausal client women aged between 45-60 years and they have not menstural cycle during the preceding 12 months in health center were randomly selected and assigned in two groups ., 53 client in the intervention group and 53 client in the control group at random using a random number table is placed. the samples in each group were randomly selected and are placed Based on exclusion and inclusion criteria. Data collected is using the Beck Depression Questionnaire, General Health Questionnaire, International Physical Activity questionnaire and the Questionnaire to assess demographic situation. subjects will walk for 12 weeks, three times per week for at least half an hour . intervention group record their daily steps by pedometer during study and then it will be recorded in provided check list through investigation of researcher. International physical activity questionnaire and general health questionnaire will fill every month for 3 months for all subjects . After 90 days Beck questionnaire, the General Health Questionnaire and the Physical Activity Scale will be completed for the intervention group and the control group and investigated.In the long run the research group will have their normal activities and will not participate in any walking program.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014020616501N1
Registration date: 2014-03-08, 1392/12/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-03-08, 1392/12/17
Registrant information
Name
Parvin Nikkhah
Name of organization / entity
Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8331
Email address
nikkhah.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Jundishapur Medical Science Universiry of Ahvaz
Expected recruitment start date
2014-01-05, 1392/10/15
Expected recruitment end date
2014-04-04, 1393/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of walking using pedometer on depression and general heath of post menopausal women.
Public title
Walking with pedometer, Depression, General health in postmenopausal women.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:postmenopausal women aged 60_45 years;have not menstural cycle during the preceding 12 months;Tend to walk;Subjects with mild or moderate depression. Exclusion criteria;skeletal- muscle disease, joint problems, knee, hip and foot fracture; Disease, which is discouraging walking.
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 106
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
Ahvaz University of Medical Science
Street address
Golestan highway, University of Medical Science
City
Ahvaz
Postal code
61375-15794
Approval date
2014-02-15, 1392/11/26
Ethics committee reference number
B-9229

Health conditions studied

1

Description of health condition studied
General health, Depression
ICD-10 code
f32
ICD-10 code description
ِDepressive episode

Primary outcomes

1

Description
ِِِِِDepression
Timepoint
Before and 12 weeks after study
Method of measurement
Beck Depression Questionnaire

2

Description
General Health
Timepoint
Before and 4 week, 8 week and 12 week after study
Method of measurement
GSQ-28

Secondary outcomes

empty

Intervention groups

1

Description
walking in the intervention group with pedometer performed 12 weeks. at this time is done at least 3 days per week and at least half an hour's walk.
Category
Behavior

2

Description
In the control group do not intervention during the 12-week study, only they are monitored monthly and the forms are filled.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
N 1, East, Health Center
Full name of responsible person
parvin nikkhah
Street address
Shahid Rastegari St, Ayatollah Behbahani highway
City
Ahvaz

2

Recruitment center
Name of recruitment center
N 5, West, Health Center
Full name of responsible person
Parvin Nikkhah
Street address
Kianabad
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences and Faculty of Arvan
Full name of responsible person
Dr. mostafa feghhi
Street address
Golestan highway
City
Ahvaz
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, Ahvaz Jundishapour University of Medical Sciences and Faculty of Arvan
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
Ahvaz Jondishapur University of Medical Sciences-Faculty of Arvand International Division
Full name of responsible person
Parvin Nikkhah
Position
Master of science at midwifery
Other areas of specialty/work
Street address
Golestan Avenue
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 1373 8331
Fax
+98 61 1373 8071
Email
parvinnikkhah@yahoo.com
Web page address
fnursing.ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences.
Full name of responsible person
Dr. Parvin Abedi
Position
Assistant
Other areas of specialty/work
Street address
Golestan highway
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 1373 8071
Fax
+98 61 1373 8081
Email
parvinabedi@ymail.com
Web page address
fnursing.ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Jundishapur university of medical Sciences
Full name of responsible person
Parvin nikkhah
Position
Master of science at midwifery
Other areas of specialty/work
Street address
Golestan Highway
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 1373 8071
Fax
+98 61 1373 8071
Email
parvinnikkhah@yahoo.com
Web page address
fnursing.ajums.ac.ir

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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