Investigating the effect of adding low pressure exercises to specific pelvic floor exercises on pelvic floor performance in semi-professional female athletes
Design
The clinical trial has two parallel groups and one blind strain. Simple randomization was done based on randomized blocks on 60 patients.
Settings and conduct
People go to the rehabilitation clinic under the supervision of a physiotherapist to evaluate and receive the exercise brochure and training and perform the desired exercises, and then after receiving and training the exercises, they perform the exercises for 8 weeks. The evaluator in the blind study and the participant and The interventionist is not blind.
Participants/Inclusion and exclusion criteria
Women aged 18 to 60 years who have persistent symptoms of stress urinary incontinence during the past six months and one year after giving birth and who exercise at least three days a week for more than one year. These people should not be on hormone therapy. and six months
They should not have been pregnant before pregnancy, and they should not have undergone physical therapy and not performed gynecological and urological surgery in the previous year.
and do not have neurological disease, and do not have the inability to properly contract the pelvic floor muscles and maintain the probe, and do not have irregularity in sports performance, and are able to cooperate in the subsequent evaluations and complete the questionnaire, and do not have prohibitions to do exercises.
Intervention groups
One group performs specific pelvic floor exercises that include pelvic floor contractions and the other group performs the same exercises along with low pressure exercises.
Main outcome variables
Displacement of the base of the bladder, strength and endurance of pelvic floor muscles, stress urinary incontinence, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241007063276N1
Registration date:2024-11-11, 1403/08/21
Registration timing:registered_while_recruiting
Last update:2024-11-11, 1403/08/21
Update count:0
Registration date
2024-11-11, 1403/08/21
Registrant information
Name
Atefe Gashteh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 2051
Email address
atefeh.gashte@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-04-20, 1404/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of adding hypopressive exercise to specific pelvic floor function in semiprofessional female athletes
Public title
Effect of Hypopressive exercises
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Female athletes aged 18 to 60 despite symptoms of pelvic floor disorders lasting six months
More than a year has passed since giving birth
Exercising at least three days a week for more than a year
Exclusion criteria:
Pregnancy six months before entering the study
Gynecological and urological surgeries
Age less than 18 and more than 60
Pelvic floor physiotherapy in the previous year
Neurological and psychiatric disease
Any medical prohibition to exercise
Inability to participate in subsequent evaluations
Inability to participate in subsequent evaluations
Undergoing hormone therapy
Irregularity in sports performance
Inability to properly contract the pelvic floor muscles
Inability to insert and maintain vaginal probe due to pain and discomfort
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is accessible, i.e. among semi-professional female athletes with pelvic floor disorders who are referred to the neuromuscular rehabilitation clinic of Semnan Rehabilitation Faculty to receive pelvic floor physiotherapy with the aim of managing the symptoms of pelvic floor disorders, those who consent to participate in the study and meet the entry criteria, they will be included in the study. Allocation to two groups is random and this allocation will be done using the randomized block method. For this purpose, two interventions A and B is considered in six blocks of ten as follows. When each patient enters, the physiotherapist will ask for the type of treatment from the relevant methodology. The methodologist, holding the prepared list below, chooses a number between one and six by throwing a dice, and in the selected block, selects the specified intervention (A or B) to The person is allocated and announced to the physiotherapist. In the next stages, if the selected block is filled, the dice throw is repeated, two other numbers are selected that the sequence of interventions has not yet been completed, and this work will continue until the end of all blocks and the completion of 60 cases.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is one-sided blind. The evaluator in this study does not know the type of exercises of each person and is blind, the participant and the interventionist are fully present during the exercises and are not blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Basij Boulevard, Semnan Medical Sciences Headquarters
City
Semnan
Province
Semnan
Postal code
۳۵۱۹۸۶۶۷۷۵
Approval date
2024-10-20, 1403/07/29
Ethics committee reference number
IR.SEMUMS.REC.1403.136
Health conditions studied
1
Description of health condition studied
Low pressure exercises in stress urinary incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence (female) (male)
Primary outcomes
1
Description
Endurance and strength of the pelvic floor muscles
Timepoint
At the beginning and after eight weeks of training
Method of measurement
Endurance and strength of the pelvic floor muscles with prineometer
2
Description
Displacement of the base of the bladder
Timepoint
At the beginning and after eight weeks of training
Method of measurement
Using ultrasound
3
Description
Stress urinary incontinence
Timepoint
At the beginning and after eight weeks of training
Method of measurement
One hour pad test
4
Description
quality of life
Timepoint
At the beginning and after eight weeks of training
Method of measurement
Quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: This group performs specific pelvic floor exercises that include pelvic floor contractions in standing and sitting positions and crouching with different rest and contraction times for eight weeks with weekly supervision by a physiotherapist.
Category
Rehabilitation
2
Description
Intervention group: Intervention group: This group performs specific pelvic floor exercises like the first group, and in addition, low pressure exercises are also performed along with it. They are performed with different rest and contraction times for eight weeks with the weekly supervision of a physiotherapist.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabatabai Rehabilitation Clinic
Full name of responsible person
Rosita Hedayati
Street address
Third Yasman St. East
City
Semnan
Province
Semnan
Postal code
3519877993
Phone
+98 23 3344 2051
Email
atefeh.gashte@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abasali Vafayi
Street address
Basij Boulevard, Semnan Medical Sciences Headquarters
City
Semnan
Province
Semnan
Postal code
۳۵۱۹۸۷۷۶۵۴
Phone
+98 23 3105 2120
Email
Sem.ums.res@Gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
10
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
Semnan University of Medical Sciences
Full name of responsible person
Rosita Hedayati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Basij Street, Semnan Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519856445
Phone
0233105
Email
Rosehed@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rosita Hedayati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Basij Street, Semnan Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519844556
Phone
0233105
Email
Rosehed@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rosita Hedayati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Basij Street, Semnan Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519856445
Phone
0233105
Email
Rosehed@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Investigating the effect of adding low pressure exercises to specific pelvic floor exercises on pelvic floor performance in semi-professional female athletes
When the data will become available and for how long
1404
To whom data/document is available
All people
Under which criteria data/document could be used
Research and treatment projects
From where data/document is obtainable
Rosita hedayati
What processes are involved for a request to access data/document
Statement of the subject of the research plan and occupational therapy