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The effect of Pilates exercise on quality of life and sexual function of postmenopausal women

Protocol summary

Study aim
The effect of Pilates exercise on quality of life and sexual function of postmenopausal women
Design
Quasi - experimental study with control group, without randomization and blinding
Settings and conduct
Sampling will be conducted in two selected health centers of Tehran University of Medical Sciences. They will be selected by purpose, according to the health center equipment for holding the Pilates classes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Natural menopause, Age 40-60 years old, At least one year after the last menstrual period, Married and living in a stable life with spouse, Having at least reading and writing skills, Ability to attend in exercise sessions, BMI between 30-20 Exclusion criteria: Menopause followed by surgery, Menopause under 40 years, Husband with multiple partnership, Regular exercise during the last 3 months, Taking Phytoestrogens or hormonal Supplements, Acute heart disease, acute mental disease, chronic disease, malignancy (cancer) Disabling Sexual Disease, Sexual Disability or premature ejaculation in husband, Occurrence of stressful experiences in the last 3 months, Failure to attend in 3 sessions of Pilates exercises continuously, or 5 sessions intermittently
Intervention groups
The intervention method in this study will be Pilates exercises for 12 weeks, 2 times a week lasting 60 minutes, and will be conducted by the researcher who has been trained by an expert Pilates coach. There will be no intervention for the control group, and the women of this group will continue to perform their routine activities, and will just fill up the registration form for sports exercises ; so if they have any exercise program, they will record it and at the end 12 weeks of intervention, CD of training Pilates exercises will be given to the control group.
Main outcome variables
Quality of life Sexual function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160821029446N4
Registration date: 2018-05-30, 1397/03/09
Registration timing: registered_while_recruiting

Last update: 2018-05-30, 1397/03/09
Update count: 0
Registration date
2018-05-30, 1397/03/09
Registrant information
Name
Maryam Damghanian
Name of organization / entity
Nursing and Midwifery Faculty, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
m-damghanian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-03, 1397/01/14
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Pilates exercise on quality of life and sexual function of postmenopausal women
Public title
The effect of Pilates exercise on quality of life and sexual function of postmenopausal women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
natural menopause age 40-60 years old at least one year after the last menstrual period Married and living a stable life with spouse Having at least reading and writing skills Ability to attend exercise sessions BMI between 30-20 Full physical health
Exclusion criteria:
Menopause followed by surgery Menopause under 40 years Husband with multiple partnership Regular exercise during the last 3 months Taking Phytoestrogens or hormonal Supplements for treatment Acute heart disease, acute mental illness, chronic disease, malignancy (cancer) Disabling Sexual Disease Sexual Disease or premature ejaculation in husband Occurrence of stressful experiences in the last 3 months Failure to attend in 3 sessions of Pilates exercises, continuously or 5 sessions, intermittently
Age
From 40 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 98
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, 12 weeks Pilates training is provided to intervention group including postmenopausal women with inclusion criteria referring to the Farmanfarmaian health center. While there is no intervention for the control group, including postmenopausal women who meet the inclusion criteria referred to the Meysam Health Center.The questionnaires will be completed at the beginning of the study and 12 weeks later, and the Pilates training CD will be given to them at the end of the study.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Nursing and Midwifery and Rehabilitation Faculty of Tehran University of Medical
Street address
Nursing and Midwifery Faculty of Tehran University of Medical Sciences, Tohid Square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-03-14, 1396/12/23
Ethics committee reference number
IR.TUMS.FNM.REC.1396.4864

Health conditions studied

1

Description of health condition studied
Sexual Function
ICD-10 code
F66.2
ICD-10 code description
Sexual relationship disorder

Primary outcomes

1

Description
Quality of life
Timepoint
At the beginning of the study, after the end of the intervention
Method of measurement
SF36 quality of life questionnaire

2

Description
Sexual Function
Timepoint
At the beginning of the study, after the end of the intervention
Method of measurement
FSFI Sex Function Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The Pilates exercises will be conducted for 12 weeks, 2 times a week for 60 minutes, and will be done by a researcher trained by an expert Pilates coach.
Category
Other

2

Description
Control group: There will be no intervention for the control group, and the people of this group will continue to perform their routine activities, and the registration form for exercises will be provided to this group to register if they have any exercise program.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farmanfarmaian Health Center
Full name of responsible person
Maryam Damghanian
Street address
School of Nursing & Midwifery, East Nosrat Ave, Towhid Square.Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4222
Email
maryam_damghanian@yahoo.com

2

Recruitment center
Name of recruitment center
Meisam Health Center
Full name of responsible person
Maryam Damghanian
Street address
School of Nursing & Midwifery, East Nosrat Ave, Towhid Square.Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4222
Email
maryam_damghanian@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Street address
School of Nursing & Midwifery, East Nosrat Ave, Towhid Square.Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4222
Email
maryam_damghanian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sahar Zamani Ahmadmahmodi
Position
MSC Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery,Tehran University Medical Science,Tohid Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733172
Phone
+98 21 6692 7171
Email
sahar.zamani.a@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, East Nosrat Ave, Towhid Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733172
Phone
+98 21 6105 4222
Email
maryam_damghanian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, East Nosrat Ave, Towhid Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733172
Phone
+98 21 6105 4222
Email
sahar.zamani.a@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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