The general aim of this research is to investigate the effect of eight weeks of swing exercises on the functional ability and quality of life of women with multiple sclerosis, emphasizing the disability index, which are divided into three groups.
Design
The statistical sample of this research includes 57 female patients with multiple sclerosis who were examined based on the EDSS physical disability index according to the neurologist's diagnosis, then randomly selected from the statistical population of multiple sclerosis patients in the range of 2-6.5 And in the control groups with 2-6.5 and experimental groups with mild disability and moderate disability.
Settings and conduct
the participants took part in a meeting to familiarize themselves with the test and explanations related to the sport of swing, Then the experimental and control groups participated in the pre-test and completed the quality of life questionnaire. The tests were conducted under the same conditions in the sports club and at the same time of the day by the researcher of each participant, and the subjects were unaware of the design process and possible results.
Participants/Inclusion and exclusion criteria
- Age range of 30 to 46 years
- Not having a nervous attack in the last year
- Not taking drugs other than disease control drugs
Intervention groups
a familiarization session with swing was held for the experimental groups, and then the training period lasted for eight weeks, three days a week for one hour, and then the main exercise protocol focused on specific spine stabilization exercises, exercises to improve proprioception in the upper and lower limbs, exercises in unstable conditions to improve balance, and central stabilization exercises. , retraining of motor units was done.
Main outcome variables
Improve upper limb function
Improve lower limb function
Improve cognitive function
Improving the quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220526054997N1
Registration date:2023-03-31, 1402/01/11
Registration timing:retrospective
Last update:2023-03-31, 1402/01/11
Update count:0
Registration date
2023-03-31, 1402/01/11
Registrant information
Name
Sara Sepehrifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3223 9345
Email address
sepehri.sara73@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-09, 1399/10/20
Expected recruitment end date
2021-01-29, 1399/11/10
Actual recruitment start date
2021-01-09, 1399/10/20
Actual recruitment end date
2021-01-19, 1399/10/30
Trial completion date
2021-01-19, 1399/10/30
Scientific title
The effects of swing training on functional ability and quality of life in multiple sclerosis women
Public title
The effects of eight weeks swing exercises on functional ability and quality of life in multiple sclerosis women with emphasis on Expanded disability Status Scale
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
at least a year should passed from patients diagnosis of MS
no other acute or chronic infection in body like mental, cardiovascular, respiratory, skin disease, high or low blood pressure, high or low eye pressure
ability to attend meetings regularly
not having a regular sports history
having disability in a specific range 4≥EDSS≥2 , 6.5≥EDSS≥4.5
absence of pregnancy
at least patients must be 30 years old
Exclusion criteria:
Inability to walk or need assistance in walking
MS relapse at least two months before the intervention
Age
From 30 years old to 46 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
57
Actual sample size reached:
47
Randomization (investigator's opinion)
Randomized
Randomization description
A stratified randomization method was used, first, 80 eligible patients in the disability range of 2 to 6.5 were selected to participate in the protocol in cooperation with the MS Association. Then the people were numbered and in order to hide the random allocation, all the numbers were placed inside a sealed envelope. after mixing the numbers, the numbers were randomly selected and classified into three groups. The basis is that if the patient did not meet the conditions of the group with mild disability, he would be put back into the envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
One-way blind:
The participants did not know about the grouping of the research, according to which category of disability was classified. In addition, they did not know about the possible effects of the protocol and exercise on the functional factors of the upper and lower limbs and mental performance, but the patients were told that the exercises are effective on your physical factors, but in order not to mislead that this The pre-test measures the performance of the upper limbs and exercises are provided to check these changes. No information was given so as not to affect the tests.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics committee of Shahid Bahonar University of Medical Sciences
Street address
pazhohesh Blvd., shahid bahonar univercity
City
kerman
Province
Kerman
Postal code
7616884987
Approval date
2020-03-30, 1399/01/11
Ethics committee reference number
IR.UK.VETMED.REC.1399.002
Health conditions studied
1
Description of health condition studied
multiple sclerosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Functional Ability of Upper Limb
Timepoint
Pre Test- 4th week of intervention - 6th week of intervention and post test
Method of measurement
9hole peg test
2
Description
fuctional ability of lower extremity
Timepoint
pre-test, fourth week, sixth week and eighth week(post-test)
Method of measurement
25foot walk test
3
Description
processing speed of memory
Timepoint
pre-test, fourth week, sixth week and eighth week(post-test)
Method of measurement
paced audiotory serial addition test
4
Description
The effect of swing exercises on the quality of life of women patients with multiple sclerosis
Timepoint
Pre-test and post-test
Method of measurement
short form 36 question
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: They performed suspended and semi-suspended swing exercises for eight weeks. Training protocol: First, ten minutes of warm-up, which included stretching and kinetic movements with a medium and low level, were performed, and then the swing exercises began. The protocol consists of eight weeks of suspended and unstable exercises, which were performed using a swing tool, and the intensity of the exercise was changed by increasing the repetitions and changing the grips and leveling of the movements.
Category
Rehabilitation
2
Description
The second intervention group: They performed suspended and semi-suspended swing exercises for eight weeks. Training protocol: First, ten minutes of warm-up, which included stretching and kinetic movements with a medium and low level, were performed, and then the swing exercises began. The protocol consists of eight weeks of suspended and unstable exercises, which were performed using a swing tool, and the intensity of the exercise was changed by increasing the repetitions and changing the grips and leveling of the movements.
Category
Rehabilitation
3
Description
Control group: The patients in this group did their normal daily activities and the things that the relevant doctor had announced and no restrictions were imposed by the researcher.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Multiple Sclerosis Association of Kerman
Full name of responsible person
Hosein Ali Ebrahimi
Street address
No. 22, Shafa Ave
City
Kerman
Province
Kerman
Postal code
7618759639
Phone
+98 34 3212 4727
Email
ebrahimi.ha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Bahonar Univercity of Kerman
Full name of responsible person
Hojatollah Ranjbar
Street address
Shahid Bahonar Univercity., Pazhoohesh Sq
City
Kerman
Province
Kerman
Postal code
7616913439
Phone
+98 34 3132 5546
Email
h.ranjbar@uk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sara sepehri
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Bahonar University of Kerman
Full name of responsible person
Sara Sepehri
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Injuries and Corrective Movements
Street address
Shahab Street,. 7th Alley, Left Side , 6thBulding
City
Kerman
Province
Kerman
Postal code
7616884987
Phone
+98 939 489 8646
Email
sepehri.sara73@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Bahonar University of Kerman
Full name of responsible person
Mansour Sahebozamani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Injuries and Corrective Movements
Street address
Shahid Bahonar University of Kerman- Faculty of Physical Education and Sport Sciences- Department of Sport Pathology and Corrective Exercises
City
Kerman
Province
Kerman
Postal code
7616884987
Phone
+98 913 397 0521
Email
sahebozamani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bahonar University of Kerman
Full name of responsible person
Sara Sepehri
Position
ph.D Student
Latest degree
Master
Other areas of specialty/work
Sport Injuries and Corrective Movements
Street address
No. 7, Shahab Street , Left Side 6th Building
City
Kerman
Province
Kerman
Postal code
7616884987
Phone
+98 939 489 8646
Email
sepehri.sara73@gmail.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All statistical information, statistical results,EDSS, quality of life results are accessible
When the data will become available and for how long
Access starts one month after the results are published
To whom data/document is available
Researchers and Health centers
Under which criteria data/document could be used
In order to use the results to raise and improve the conditions of multiple sclerosis patients
From where data/document is obtainable
sara sepehrifar
sepehri.sara73@gmail.com
What processes are involved for a request to access data/document