The main purpose of this study is to acheive a new non-medical treatment which can be used as a complement and non-complicated treatment in Multiple Sclerosis patients suffering from fatigue, depression and paresthesia. In a randomized clinical trial among patients referred to Multiple Sclerosis community of Kermanshah 54 female patients randomly divided into 3 groups. All the patients are suffered from fatigue,depression and paresthesia for at least a month, their age range should be 20-50 and they should have EDSS criteria less or equal 6 and Exclusion criteria are: severe fatigue, depression and paresthesia that need to be treated by medicine ;patients having Multiple Sclerosis attack in the recent month. They are divided into 3 groups,respectively, Yoga, acqualic training and control group. obtaining knowingly consent forms from the patient and if the patient is not willing to continue is knowingly excluded. At the beginning and the end of the study questions are measured and compared with each other.At the end clinical manifestation improvement response rate in the 3 groups are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405188323N8
Registration date:2014-07-21, 1393/04/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-21, 1393/04/30
Registrant information
Name
Nazanin Razazian
Name of organization / entity
Neurology Department of Kermanshah Faculty of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 3409
Email address
nrazazian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative survey of influence of yoga and aquatic training on fatigue,depression and paresthesia in Multiple Sclerosis patients
Public title
Treatment of fatigue,depression and paresthesia in Multiple Sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (Age range 20-50; having EDSS criteria less or equal 6;suffering from fatigue, depression and paresthesia base on FSS criteria, Beck criteria ans SNR criteria;not using effective drugs in fatique, depression and paresthesia; contentment in participating in each of the 3 treatment groups). Exclusion criteria: (severe fatigue, depression and paresthesia that need to be treated by medicine ;patients having Multiple Sclerosis attack in the recent month;patients doing any kinds of sport; patients suffering from concurrent diabetes and cardiac disease, arthritis or psychological diseases).
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical
Street address
Shahid beheshti street, Kermanshah.
City
Kermanshah
Postal code
Approval date
2014-01-14, 1392/10/24
Ethics committee reference number
44854
Health conditions studied
1
Description of health condition studied
fatigue,depression and paresthesia in Multiple Sclerosis patients
ICD-10 code
G35-G37
ICD-10 code description
Multiple Sclerosis
Primary outcomes
1
Description
Fatigue,depression,paresthesia in Multiple Sclerosis patients
Timepoint
At the beginning of the first week and at the end of the eighth week.
Method of measurement
FSS,Beck,SNR
Secondary outcomes
1
Description
change in gate
Timepoint
At the beginning of the first week and at the end of the eighth week