Effects of selected Tai Chi exercises and core stabilization exercises on balance and quality of life in multiple sclerosis patientswith emphasis on EDSS
The aim of this Double-blind study (Blinding for groups of participants and the receiver test )will be the comparison of the effects of Tai Chi and core stability exercise on (static and dynamic) balance and quality of life in multiple sclerosis women with emphasis on EDSS. 72 women with multiple sclerosis with 1≤EDSS≤6 voluntarily participated in this study. Patients will be randomly divided into three groups (Tai Chi = 24 people, core stability=24 people, control=24 people). Then Each group will be divided into two subgroups( mild degree of disability and moderate degree of disability). Before the beginning of training, static and dynamic balance will be evaluated by the use of Biodex balancing machine gauge, and by the use of the quality of life questionnaire which contains 54 questions for multiple sclerosis patient, the quality of life of participants will be evaluated. The first intervention groups during 8 weeks (three times a week) will practice Tai Chi and the second innervation group in the same period, will participate in the core stability exercises . In this period, the control group will not experience any exercise. After training period, the balance (static and dynamic), stability and quality of life of participants will be re-evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012422194N2
Registration date:2016-08-04, 1395/05/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-04, 1395/05/14
Registrant information
Name
Mansour Sahebozamani
Name of organization / entity
Shahid Bahonar University
Country
Iran (Islamic Republic of)
Phone
+98 34 3323 3423
Email address
sahebozamani@mail.uk.ac.ir
Recruitment status
Recruitment complete
Funding source
Neurology Research Center, Kerman University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of selected Tai Chi exercises and core stabilization exercises on balance and quality of life in multiple sclerosis patientswith emphasis on EDSS
Public title
The effects of exercise therapy on improvement of symptoms of multiple sclerosis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Without any history of cardiovascular disease, Metabolical and epilepsy ؛ The definitive diagnosis of MS by the neurologist؛ At least has three periods of relapse and remission؛ not being pregnant؛ Has not done any exercise at least for three regular month؛ Willing to participate in the research project؛ At least last three month from the last MS attack ؛EDSS shold be between 1 to 6 .
Exclusion criteria: MS relapse during treatment ؛ During intervention becomes pregnant؛ Exeret of intervention of patients medication should be change during 8 weeks.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Neurology Research Center, Kerman University of medcal sciences
Street address
Deputy of Research and Technology of , Kerman University of Medical Sciences, Somayeh Cross way, Kerman
City
Kerman
Postal code
7615747653
Approval date
2016-01-06, 1394/10/16
Ethics committee reference number
IR.KMU.REC.1394.455
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervvous system
Primary outcomes
1
Description
Static balance
Timepoint
3 days before the begining of intervention and 3 days after the end of intervention
Method of measurement
Biodex
2
Description
Dynamic balance
Timepoint
3 days before the begining of intervention and 3 days after the end of intervention
Method of measurement
Biodex
3
Description
Quality of Life
Timepoint
3 days before the begining of intervention and 3 days after the end of intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
8 Weeks tai chi exercise
Category
Rehabilitation
2
Description
8 Weeks core stability exercise
Category
Rehabilitation
3
Description
control group without any exercise
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Researcher Center, Kerman University of Medical Sciences
Full name of responsible person
Hossein Ali Ebrahimi
Street address
Neurology Research Center, kerman University of Medical Sciences , Kosar blvd, Kerman
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology , Kerman University of Medical Sciences
Full name of responsible person
Hossein Ali Ebrahimi
Street address
Kerman University of medical sciences ,Deputy of Research and Technology, Somayeh Cross way, Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology , Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Bahonar University
Full name of responsible person
Mahtab Mirzaee
Position
MS C
Other areas of specialty/work
Street address
Department of Sport Injuries and Corrective Exercise, Faculty of Physical Education and Sport Science, Shahid Bahonar University of Kerman
City
Kerman
Postal code
76169114111
Phone
+98 34 3251 3534
Fax
Email
mahtab.mirzai70@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahud Bahonar University
Full name of responsible person
Mansur Sahebozamani
Position
Professor
Other areas of specialty/work
Street address
Department of Sport Injuries and Corrective Exercise, Faculty of Physical Education and Sport Sciences, Shahid Bahonar University of Kerman
City
Kerman
Postal code
7616914111
Phone
+98 33233423
Fax
Email
Sahebozamani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Bahonar University
Full name of responsible person
Mahtab Mirzaee
Position
MS C
Other areas of specialty/work
Street address
Department of Sport Injuries and Corrective Exercise, Faculty of Physical Education and Sport Sciences, Shahid Bahonar University of Kerman
City
Kerman
Postal code
7617777839
Phone
+98 34 3251 3534
Fax
Email
mahtab.mirzai70@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)