The effect of pelvic floor muscle exercises therapy on the fatigue and quality of life in women with multiple sclerosis suffering from urinary disorders
To estimate the effect of pelvic floor muscles exercise therapy program on fatigue and quality of life in women with urinary disorders due to multiple sclerosis.
Design
This study is an experimental and single-blind clinical trial with parallel groups. In this study, available participations will include based on inclusion criteria and as absolute random will be divided into two groups using sealed envelopes according to the EDSS and type of urinary tract disorder.
Settings and conduct
the intervention is performed in the school of Rehabilitation Sciences of Iran University of Medical Sciences. In this study, both the assessor and the and data analyzer are blind.
Participants/Inclusion and exclusion criteria
inclusion criteria: Women whose MS diagnosis has been confirmed by a neurologist and aged 18-50 years. Women with urinary disorders and "overactive bladder score" equal or more than 8 , have relapse and remitting type of MS and have no new attack within the last 3 months. Additionally, dosage of the urinary medications remain unchanged within the last 3 months and having the "Expanded Disability Status Scale" score less than 7 based on the physician diagnosis.
exclusion criteria: Individuals will exclude if they have the "Mini-Mental State Examination Test" score below 18, be pregnant or have the urinary tract infection.
Intervention groups
At first, the specific pelvic floor exercise therapy, along with informing people of the pelvic floor muscles, are performed for intervention group.These exercises will be done at home by participant for two months. Sequence of exercises are: warm up, main exercises and cool down. The control group, based on physician prescription, will receive urinary medications.
Main outcome variables
In this study, the Fatigue is the main outcome variable.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140222016680N7
Registration date:2020-04-13, 1399/01/25
Registration timing:registered_while_recruiting
Last update:2020-04-13, 1399/01/25
Update count:0
Registration date
2020-04-13, 1399/01/25
Registrant information
Name
Shohreh Noorizadeh Dehkordi
Name of organization / entity
Iran University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
noorizadeh.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pelvic floor muscle exercises therapy on the fatigue and quality of life in women with multiple sclerosis suffering from urinary disorders
Public title
The effect of pelvic floor muscle exercises therapy program on the fatigue and quality of life in women with multiple sclerosis suffering from urinary disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women whose MS diagnosis has been confirmed by a neurologist.
Women with age range between 18-50 years.
Women with urinary disorders and "overactive bladder" score equal or above 8
Women with relapse and remitting type of MS and they have not had a new attack within the last three months.
Women whose dosage of the urinary medications remains unchanged within the last three months.
Women who have an "Extended Disability Status Scale" score below 7 based on physician diagnosis.
Exclusion criteria:
1. Individuals who have "Mini-Mental State Examination" score below 18
2. Women who are pregnant.
3. Women who have urinary tract infection.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
People as absolute random will be divided into two groups using random sealed envelopes. They will be selected randomly by a person who is unaware of the groups. Random blocks (permuted block randomization) with four blocks will be used for randomization. According to the sample size of 30, eight blocks will be generated using the online site (www.sealedenvelope.com). For concealment in the randomization process, unique code will be used on each envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, َََََََََََََََََAssessor who evaluates the outcome measures of study will be blind to the allocation of the two treatment groups. َ
Placebo
Not used
Assignment
Parallel
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
ran University of Medical Sciences, Hemmat Expressway, Tehran, Iran
City
Teharan
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-12-28, 1398/10/07
Ethics committee reference number
IR.IUMS.REC.1398.1007
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
The amount of fatigue
Timepoint
Measurement of fatigue before and immediately after intervention and one months after intervention
Method of measurement
by using the Modified fatigue impact scale questionnaire
Secondary outcomes
1
Description
quality of life
Timepoint
To measure quality of life before and immediately after intervention and one months after intervention
Method of measurement
by using the Qualiveen-30 questionnaire-short form
Intervention groups
1
Description
intervention group: This group only perform pelvic floor exercises at home once a day for two months.
Category
Rehabilitation
2
Description
Control group: They recieve medication based on physician prescription to control their urinary disorder.