Protocol summary

Summary
(1) Objectives: The impact of walking using pedometer on sexual function of post menopausal women. (2) Design: This study is a clinical trial that will be conducted using random sampling. (3) Setting and conduct: Health Center and among the visitors to the 106 by the initial interviews after the researcher selected and in the control and intervention. On the first meet will be completed the demographic information questionnaire, sexual performance disorder and physical activity questionnaire for samples. The control and intervention group will be examined after 4 weeks and again after 8 weeks and to be completed for them sexual performance disorder and physical activity questionnaire. (4) Participants including major eligibility criteria: Inclusion main criteria included: postmenopausal women aged 60_45 years؛ cessation of menstruation for 12 months؛ the tendency is to walk and people with sexual dysfunction. Exclusion main criteria included: women with muscular_skeletal disease؛ Heart disease is the prohibition on walk؛ hormone therapy. (5) Intervention: To each of the women in the intervention group is a device will be delivered to the pedometer. During the study, the intervention group with a pedometer count your daily steps records on a daily basis in a calendar that is in their possession and every week walking through SMS and its benefits to them will remember and follow.The control group received no intervention. (6) Main outcome measures variables: sexual performance, sexual desire, stimulation, humidity, orgasm, satisfaction.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016060228220N1
Registration date: 2016-07-13, 1395/04/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-07-13, 1395/04/23
Registrant information
Name
Ilnaz Zohrabi
Name of organization / entity
School of Nursing and Midwifery, Ahvaz Jundishapur Uninersity of Medical Science and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8331
Email address
zohrabi.i@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ground floor, Ahvaz Junishapur University of Medical Science and Health Services of Department Research Development and Technological, Academic city, Ahvaz
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of walking using pedometer on sexual function of post menopausal women
Public title
The impact of Walking on sexual function in postmenopausal women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion main criteria included: postmenopausal women aged 60_45 years؛ cessation of menstruation for 12 months or having evidence of an increase in pituitary hormones (FSH and LH)؛ a desire for a walk؛ people with sexual dysfunction and have at least basic literacy. exclusion main criteria included: women with Muscular_Skeletal disease؛ knee joint problems؛ History of hip and legs fractures؛ Heart disease is the prohibition on walk؛ hormone therapy.
Age
From 45 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 106
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ahvaz JundiShapur University of Medical Sciences and Health Services of Ethics Committee
Street address
Ahvaz Jundishapur University of Medical Science and Health Services, Golestan BLV, Ahvaz
City
Ahvaz
Postal code
61357-15794
Approval date
2016-04-20, 1395/02/01
Ethics committee reference number
IR.AJUMS.REC.1395.62

Health conditions studied

1

Description of health condition studied
Sexual function
ICD-10 code
F52.9
ICD-10 code description
Unspecified sexual dysfunction, not caused by organic disorder or disease

Primary outcomes

1

Description
Sexual function
Timepoint
Before the intervention, 4 week after the intervention began, 8 week after the intervention.
Method of measurement
FSFI questionnaire

Secondary outcomes

1

Description
physical activity
Timepoint
Before the intervention,4 week after the intervention, 8 after the intervention.
Method of measurement
IPAC physical activity questionnaire

Intervention groups

1

Description
To any of those groups after the project justification, will be given a pedometer. After you set up pedometer, and learning how to use it in order to properly control the performance of the pedometer will be asked in the same place for 5 minutes walk and record the steps by pedometer will control their own while counting the steps generally done by scholar also verbally. It is also taught that the pedometer every day from the beginning of the day excluding bedtime and bathe on a belt or a skirt on the dominant leg (left or right) to install and use. Each pedometer step number 40000 in his memory.Then with a small note book information necessary to use the pedometer and ways to communicate with the researcher in it and people will be trained. The intervention group recommended to walk with each step you feel comfortable with starting number and each week add 500 steps to its previous. Then the researcher each week and encouraging message or a phone call _ a report for a group incentive intervention and encourage people to do the daily walk, a report of the status of progress can be taken up to the end of the 8 week of each individual group SMS and 8 week intervention a phone call and an educational pamphlet will receive. At the end of weeks 4 and 8 physical activity and sexual function questionnaire will be completed for the intervention group. At the end of the note book and pedometer will be collected.
Category
Lifestyle

2

Description
The control group in the study after it is accepted within 8 weeks of your routine life and at the end of week 4 and 8, physical activity and sexual performance disorder questionnaire, for they will be completed. At the end of the study of educational pamphlets about the benefits available to women in the walking group will also control.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Eeast Health Center
Full name of responsible person
Somaye Ansari
Street address
Ahvaz Eeast Health Center, facing the Haftetir Park, Rastegari Street, Ayatollah Behbahani highway, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Doctor Behzad Sharif Makhmalzadeh
Street address
Ground floor, Ahvaz Junishapur University of Medical Science and Health Services of Department Research Development and Technological, Academic city, Ahvaz
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 Jundishapur University of Medical Science
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 Nursing and Midwifery, JundiShapur University of Medical Sciences and Health Services
Full name of responsible person
Ilnaz Zohrabi
Position
Student Masters of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, JundiShapur University of Medical Sciences and Health Services
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
zohrabi.i@ajums.ac.ir؛ ilnaz.zohrabi67@gmail.com
Web page address
www.ajums.ac.ir؛ www.fnursing.ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Science and Health Services
Full name of responsible person
Ilnaz Zohrabi
Position
Student Masters of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ahvaz JundiShapur University of Medical Sciences and Health Services , Golestan BlV, Ahvaz
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
ilnaz.zohrabi67@gmail.com؛ zohrabi.i@ajums.ac.ir
Web page address
www.ajums.ac.ir؛ www.fnursing.ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
JundiShapur University of Medical Sciences and Health Services, School of Nursing and Midwifery
Full name of responsible person
Ilnaz Zohrabi
Position
Student Masters of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, JundiShapur University of Medical Sciences, Golestan BlV, Ahvaz
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
ilnaz.zohrabi67@gmail.com؛ zohrabi.i@ajums.ac.ir
Web page address
www.ajums.ac.ir؛ www.fnursing.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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