Investigating the effect of pelvic floor muscle training and breathing exercise on pelvic floor muscle activity, diaphragm activity, and urinary symptoms in patients with multiple sclerosis
Investigating the effect of PFM exercise and breathing exercises on PFM activity, diaphragm muscle activity, and urinary symptoms in MS patients with urinary disorders.
Design
Randomized controlled trial, with a factorial design on 50 patients. Randomization is done using the Randomization website.
Settings and conduct
Patients with relapsing-remitting MS are included in the study, taking into account the inclusion and exclusion criteria and being eligible after diagnosis by a specialist doctor. Then participants will be given a consent form and personal information. Patients are divided into two groups. The participants in the control group perform PFM exercises and participants in the intervention group perform breathing exercises along with the PFM exercises. All evaluations and exercises will be done in the laboratory of the Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran
Participants/Inclusion and exclusion criteria
Diagnosis of relapsing-remitting MS disease; Absence of cardiovascular diseases, kidney diseases, rheumatism, visceral diseases, other neurological diseases (other than MS); malignancies and infections; Absence of pregnancy or history Giving birth in the last 6 months; Not having a history of surgery to treat urinary incontinence; Absence of prolapse of pelvic organs with severity higher than 2
Intervention groups
Intervention group: the group receiving PFM exercises along with breathing exercises for 8 weeks and 4 days a week
Control group: the group receiving PFM exercises for 8 weeks and 4 days a week
Main outcome variables
Urinary incontinence diagnosed by a physician; PFM function: bladder base displacement measured by ultrasound imaging; displacement: using diagnostic ultrasound; Diaphragm muscle function: Diaphragm displacement and thickness will be investigated by ultrasound.
General information
Reason for update
Acronym
EDSS: Expand Disability Status Scale; ICIQSF: Incontinence Questionnaire Short Form; MMSE: Mini-Mental State Examination; MS: Multiple Sclerosis; PFM: pelvic floor muscle; RCT: Randomized controlled trial
IRCT registration information
IRCT registration number:IRCT20180916041051N3
Registration date:2024-05-23, 1403/03/03
Registration timing:registered_while_recruiting
Last update:2024-05-23, 1403/03/03
Update count:0
Registration date
2024-05-23, 1403/03/03
Registrant information
Name
Shabnam Shahali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 8769
Email address
shahali.sh@iums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-11-22, 1404/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of pelvic floor muscle training and breathing exercise on pelvic floor muscle activity, diaphragm activity, and urinary symptoms in patients with multiple sclerosis
Public title
Effectiveness of pelvic floor exercises and breathing exercises on urinary disorders of people with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18to50 years
Diagnosis of relapsing-remitting MS disease
MMSE scale score greater than 24
EDSS scale score less than 3.5
Not suffering from cardiovascular diseases, kidney diseases, rheumatism, visceral diseases, other neurological diseases (other than MS), malignancies and infections
No pregnancy or history of childbirth in the last 6 months
Not having a history of surgery to treat urinary incontinence
Absence of prolapse of pelvic organs with intensity higher than 2
Not having a score of 19-21 from the ICIQ-SF questionnaire
Not having a history of MS relapse in the last 3 month
Ability to understand and write concepts and information
Not having chronic obstructive pulmonary disease, bronchitis and tuberculosis
Absence of MS plaques in the medulla (due to the presence of respiratory control areas)
Body mass index (BMI) below 30
Exclusion criteria:
The patient's unwillingness to participate in the study
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using the Randomization website. Both groups will be matched in terms of demographic characteristics. They will be randomly divided into two treatment groups with a ratio of 1:1. Random allocation is done by the variable block method, which includes 4-letter blocks, made of letters A and B. The obtained treatment allocation is placed in sealed and numbered envelopes in the form of letters A and B. This process is done by someone outside the research team before the start of the study. After the initial evaluations by the examiner, the numbered envelopes are presented to him according to the sequential number of each person entered into the study, and the therapeutic intervention is adjusted based on the letters inside the envelope. The examiner is unaware of the letters inside the envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical sciences
Street address
Iran University of Medical Sciences, Hemet Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2024-04-14, 1403/01/26
Ethics committee reference number
IR.IUMS.REC.1403.027
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of urinary incontinence
Timepoint
It is checked at the beginning of the study (before the intervention) and the last session
Method of measurement
ICIQSF questionnaire
Secondary outcomes
1
Description
PFM function
Timepoint
It is checked at the beginning of the study (before the intervention) and the last session
Method of measurement
It is measured by ultrasound imaging
2
Description
Diaphragm muscle function
Timepoint
It is checked at the beginning of the study (before the intervention) and the last session
Method of measurement
It is measured by ultrasound imaging
Intervention groups
1
Description
Intervention group: Receiving breathing exercises and PFM exercises. Breathing exercises will be done using the Power Breathe classic device (POWERbreathe International Ltd, England). This device strengthens the respiratory muscles by creating appropriate pressure (10-15 mmHg). Participants will use this device while doing PFM exercises at the same time. Participants will do exercises 4 days a week for 8 weeks (24 sessions) under the supervision of a physiotherapist.
Category
Rehabilitation
2
Description
Control group: Receiving PFM exercises. Exercises will be done in supine, sitting, quadruped, standing, and walking. The participant is asked to contract the PFM and hold each contraction for 5-10 seconds. Exercises will be performed three times daily (morning, evening, and night) with 8-10 repetitions in each exercise set. Participants will do exercises 4 days a week for 8 weeks (24 sessions) under the supervision of a physiotherapist.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
دانشکده ی توانبخشی دانشگاه علوم پزشکی ایران
Full name of responsible person
شبنم شاه علی
Street address
Madder Square, Maddkaran St., Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۵۴۵۹۱۳۴۸۷
Phone
+98 21 2226 9608
Email
shabnamshahali@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
رضا فلک
Street address
Iran University of Medical Sciences, Hemet Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
Falak.r@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
شبنم شاه علی
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Madder Square, Maddkaran St., Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۵۴۵۹۱۳۴۸۷
Phone
+98 21 2222 8051
Email
shabnamshahali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
هلاکو محسنی فر
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Madder Square, Maddkaran St., Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۵۶۸۶۴۸۵۱۱
Phone
+98 21 2222 8051
Email
Mohsenifarpt@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shabnam Shahali
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Madder Square, Maddkaran St., Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۵۶۸۶۴۸۵۱۱
Phone
+98 21 2222 8051
Email
shabnamshahali@yahoo.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 further information
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
Data related to the main outcomes are shared
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Use of the data can be done for further research work in the future.
From where data/document is obtainable
Iran University of Medical Sciences, Faculty of Rehabilitation, Madadkaran St., Madar Square, Tehran. Postal code: 1545913487. shabnamshahali@yahoo.com
What processes are involved for a request to access data/document
First, the person sends a message to the given email, after that the information is provided to the person by considering the job of the person who is working in the university and seeing the articles of the person who is identified as a researcher.