Determining the effect of twelve weeks of light aerobic exercise on cognitive and motor functions of women with non-severe MS
Design
Clinical trial with two experimental and control groups, without blinding; Randomized by JPower software and used on 30 patients with MS.
Settings and conduct
Exercises in the gym that are suitable for the physical conditions of MS patients, two sessions per week, and each session for one hour of light and sub-maximal aerobic exercise, for 24 sessions, under the supervision of an experienced trainer in compliance with all the conditions of these patients. will take
Participants/Inclusion and exclusion criteria
eighteen to forty years old
• Female gender
• The physical disability score of non-severe MS patients based on the EDSS scale is up to 5.5• Not having underlying diseases
• Not taking any medicine other than the medicine needed to treat MS
• Not engaging in any sports and physical therapy activities at the same time as conducting this research
Exit criteria
• Any dissatisfaction due to exercises
• Two sessions of continuous absence or three sessions of intermittent absence Any injury to the subject due to exercises
• The option to leave the test at any time, by the examinee
• Criteria for not entering the research The presence of any underlying disease, including epilepsy and...
• Taking certain drugs other than drugs related to MS disease
Intervention groups
After the call, qualified people will be selected and then randomly placed in two groups. Two groups will be given a pre-test, then the experimental group will be subjected to an intervention program for 12 weeks, and at the end, both groups will be given a post-test. .
Main outcome variables
Impact on the amount of dynamic balance factors; static; flexibility ; reaction time; Memory ; two-handed coordination; Fatigue rate of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231222060493N1
Registration date:2024-02-10, 1402/11/21
Registration timing:registered_while_recruiting
Last update:2024-02-10, 1402/11/21
Update count:0
Registration date
2024-02-10, 1402/11/21
Registrant information
Name
marzieh mahdiabady
Name of organization / entity
Razi university of kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 83 3432 9784
Email address
mmehdiabady2@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-07, 1402/11/18
Expected recruitment end date
2024-02-29, 1402/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of twelve weeks of light aerobic exercise on cognitive and motor performances in women with non-severe Multiple Sclerosis
Public title
The effect of twelve weeks of light aerobic exercise on cognitive and motor performances in women with non-severe Multiple Sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
age range of eighteen to forty years• The gender of the subjects is female.Physical disability score of non-severe MS patients based on EDSS scale up to 5.5 (30-11)• Not having underlying diseases such as chronic heart diseases, arthritis or cognitive disorders• Not taking any medicine other than the medicine needed to treat MS• Not engaging in any sports and physical therapy activities at the same time as conducting this research
Exclusion criteria:
• Any dissatisfaction or problem caused by the exercises• Two sessions of continuous absence or three sessions of intermittent absence of the subject• Any injury caused to the subject due to exercises• The option to leave the test at any time, by the examinee• Criteria for not entering the research• The presence of any underlying disease, including epilepsy and...• Taking any specific medication other than MS related medications
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ethics Committee ofRazi University
Street address
Kermanshah . Taq Bostan . University St . Razy University . Deputy Research Area
City
Kermanshah
Province
Kermanshah
Postal code
6714414874
Approval date
2023-09-29, 1402/07/07
Ethics committee reference number
IR.RAZI.REC.1402.054
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Change in static equilibrium
Timepoint
Static balance is measured before interventional exercises, and this factor will be measured again after twelve weeks of interventional exercises.
Method of measurement
by STROK static balance test
2
Description
A change in dynamic equilibrium
Timepoint
Dynamic balance is measured before interventional exercises, and this factor will be measured again after twelve weeks of interventional exercises.
Method of measurement
Y balance meter device
3
Description
Change in flexibility
Timepoint
Flexibility is measured before interventional exercises, and this factor will be measured again after twelve weeks of interventional exercises.
Method of measurement
Wells flexibility test
4
Description
Change in reaction time
Timepoint
Before starting the intervention exercises, the reaction time is measured and after applying the intervention exercises for twelve weeks, this factor will be measured again.
Method of measurement
Reaction time device from Lafayette company number 6305
5
Description
Changes in bimanual coordination
Timepoint
Bimanual coordination is measured before interventional exercises, and this factor will be measured again after twelve weeks of interventional exercises.
Method of measurement
Model 32532 two-handed continuous coordination device made by Lafayette Instrument Company
6
Description
Change in memory
Timepoint
Memory is measured before interventional exercises, and this factor will be measured again after twelve weeks of interventional exercises.
Method of measurement
En-back memory evaluation software
7
Description
Change in fatigue
Timepoint
Before starting the interventional exercises, the level of fatigue is measured by the FSS fatigue questionnaire, and after twelve weeks of interventional exercises, this factor will be measured again.
Method of measurement
FSS fatigue scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: After completing all the pre-tests, the experimental group will be affected by the intervention of light and sub-maximal aerobic exercise program for twenty-four sessions in twelve weeks. The exercises will be two sessions per week, with a duration of one hour in each session, and each training session includes warming up, related exercises, and cooling down. It will be done at the end of the post-exams.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah MS Association
Full name of responsible person
Mitra Chamani Fard
Street address
Six-story unit of two buildings, Shahid Square, Elahia Street, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6719945230
Email
mmehdiabady2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Dr. Mohammad Nabi
Street address
Faculty of sports sciences . Razy University . Taq Bostan . University St . Kermanshah . Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4515
Email
mmehdiabady2@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi University of Kermanshah
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
Razi University of Kermanshah
Full name of responsible person
Marzieh Mehdi Abadi
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Learning and motor control
Street address
Faculty of Sports Sciences . Razi University . Taq Bostan . University St . Kermanshah . Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3836 2077
Email
mmehdiabady2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
marzieh mehdiabadi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Learning and motor control
Street address
Faculty of sports . Razy University . University St . Taq Bostan . Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3845 8428
Email
mmehdiabady2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Marzieh Mehdiabadi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Learning and motor control
Street address
Faculty of Sports . Razi University . University St .Taq Bostan . Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3845 8428
Email
mmehdiabady2@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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after de-identifying the subjects.
When the data will become available and for how long
Six months after the results are published
To whom data/document is available
All people if they submit an official request
Under which criteria data/document could be used
Requesting access to data for any purpose is permitted
From where data/document is obtainable
If you need to receive documents, contact Marzieh Mehdiabadi, a master's student at Razi University, via email at the following email address.mmehdiabady2@gmail.com
What processes are involved for a request to access data/document
In case of submitting an official request, announcing the relevant reasons and mentioning the full details, the data will be announced via email after 72 hours.