The aim of this study was to determine the effect of Pilates exercise on urinary incontinence and sexual function in middle-aged women.
Design
Clinical trial, two groups, simple randomization of even and odd on 100 women with urinary incontinence and sexual dysfunction
Settings and conduct
In this study, among all middle-aged women referred to the health center (clinic of Imam Khomeini Hospital), 60 middle-aged women with urinary incontinence and sexual dysfunction who were eligible for the study will be examined. Took. In the Pilates exercise intervention group, it will be performed under the supervision of a Pilates instructor.
Participants/Inclusion and exclusion criteria
Inclusion criteria: urinary incontinence and impaired sexual function; age range 60 to 65 years old; having the physical and mental ability to cooperate with research; minimum reading and writing skills
Intervention groups
Intervention group: Pilates exercises under the supervision of a Pilates instructor. Control group: there will be no intervention.
Main outcome variables
Urinary incontinence and sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210922052554N1
Registration date:2021-10-16, 1400/07/24
Registration timing:registered_while_recruiting
Last update:2021-10-16, 1400/07/24
Update count:0
Registration date
2021-10-16, 1400/07/24
Registrant information
Name
fatemeh aminizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 0000
Email address
aminizadeh.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-02, 1400/07/10
Expected recruitment end date
2021-12-01, 1400/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Pilates exercise on urinary incontinence and sexual function of middle-age women
Public title
The effect of Pilates on urinary incontinence and sexual function of women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Urinary incontinence and impaired sexual function
Age range 60 to 65 years old
Having the physical and mental ability to cooperate with research
Minimum reading and writing skills
Exclusion criteria:
Reluctance to continue cooperation
Occurrence of any physical condition requires medical treatment and care
Occurrence of any mental condition requires medical treatment and care
Occurrence of any problem such as loss of loved ones and hospitalization that the person is unable to continue studying.
Age
From 60 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, even and odd, odd numbers will be in the intervention group and even numbers will be in the control group.
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
Ethics committee of Ahvaz University of Medical Sciences
Street address
Ahvaz University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2021-09-04, 1400/06/13
Ethics committee reference number
IR.AJUMS.REC.1400.341
Health conditions studied
1
Description of health condition studied
Middle-aged women with urinary incontinence and sexual dysfunction
ICD-10 code
F52.8
ICD-10 code description
Other sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
Urinary incontinence
Timepoint
Measurement of urinary incontinence before and 6 weeks after intervention
Method of measurement
ICIQ-UI Urinary Incontinence Questionnaire
2
Description
Sexual function
Timepoint
Measurement of sexual function before and 6 weeks after the intervention
Method of measurement
PISQ -12 Sexual Function Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: performing 6 pilates exercises under the supervision of a pilates instructor. These exercises include stretching, extension, abdominal exercises and shaking the heel and foot, which will be done in different positions of sleeping, sitting and standing, depending on the level of readiness of the person.
Category
Rehabilitation
2
Description
Control group: There will be no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Ahvaz
Full name of responsible person
Alireza Ghanbaran
Street address
Imam Khomeini Hospital, Shohada Square, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
info@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Ahvaz University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Iravani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
iravani-m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Iravani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
iravani-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Aminizadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan st
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Fax
Email
aminizadeh.f@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available