Determining the effect of pelvic floor muscle exercise on urinary incontinence and leisure activities of women with Multiple Sclerosis
Design
Experimental research without control group will be performed on 12 female patients that they will be selected by convenience sampling.
Settings and conduct
The research place will be located in the occupational therapy clinic of Sina Hospital in Hamadan. Patients will go there and pelvic floor exercises will be done under the supervision of occupational therapists. Blinding will not do in research.
Participants/Inclusion and exclusion criteria
Capable to write and read
Don't have any other diseases
Intervention groups
Intervention group: Patients do exercise 3 times a week for 8 weeks. These exercises are performed under the supervision of occupational therapists. This series of exercises includes three sport movements: Bird dog, Plank and Leg lift, which are used to strengthen the pelvic floor muscles.
Main outcome variables
Urinary incontinence
Leisure activity
General information
Reason for update
Acronym
MS
IRCT registration information
IRCT registration number:IRCT20200509047370N1
Registration date:2020-08-27, 1399/06/06
Registration timing:retrospective
Last update:2020-08-27, 1399/06/06
Update count:0
Registration date
2020-08-27, 1399/06/06
Registrant information
Name
Seyed Mohammad Sadegh Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1571
Email address
hosseini.ot@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of pelvic floor muscle exercise on urinary incontinence and leisure and leisure time of women with Multiple Sclerosis
Public title
Effect of pelvic floor muscle exercise on Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Capable to write and read
Don't have any other diseases
Exclusion criteria:
Dissatisfaction with participating to research in any part of its implementation
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan Universiry of Medical Sciences
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838841
Approval date
2020-04-25, 1399/02/06
Ethics committee reference number
IR.UMSHA.REC.1399.080
Health conditions studied
1
Description of health condition studied
multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Urinary Incontinence
Timepoint
2 months
Method of measurement
ICIQ-UI SF
2
Description
leisure
Timepoint
2 months
Method of measurement
leisure multiple sclerosis questionnaire
3
Description
Intimacy and sexuality
Timepoint
2 months
Method of measurement
The multiple sclerosis intimacy and sexuality questionnaire-19
4
Description
Fatigue
Timepoint
2 months
Method of measurement
Fatigue Severity Scale (FSS)
5
Description
Depression Anxiety Stress
Timepoint
2 months
Method of measurement
Depression Anxiety Stress Scale (DASS21)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients exercise 3 times a week for 8 weeks. These exercises are performed under the supervision of occupational therapists. This series of exercises includes three sports movements: Bird dog, Plank and Leg lift, which are used to strengthen the pelvic floor muscles.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Occupational Therapy clinic in Sina hospital
Full name of responsible person
Seyed Mohammad Sadegh Hosseini
Street address
Honarestan
City
Hamadan
Province
Hamadan
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 81 3827 4184
Email
hosp_sina@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Bashirian
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838841
Phone
+98 81 3838 0717
Email
m_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Sadegh Hosseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838841
Phone
+98 81 3838 1571
Fax
Email
hosseini.ot@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Sadegh Hosseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838841
Phone
+98 81 3838 1571
Fax
Email
hosseini.ot@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Sadegh Hosseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838841
Phone
+98 81 3838 1571
Fax
Email
hosseini.ot@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Determining the effect of pelvic floor muscle exercise on urinary incontinence and leisure and leisure time of women with Multiple Sclerosis
When the data will become available and for how long
Start access after printing the article
To whom data/document is available
researchers
Under which criteria data/document could be used
Analysis between variables
From where data/document is obtainable
authors
What processes are involved for a request to access data/document
Requests from authors and a maximum of one month will be answered.