Protocol summary

Summary
The objective of this clinical trial study was to investigate the effect of Yoga on multiple sclerosis. A total of 60 patients with MS from Kohgiloyeh and Boirahmad province were randomly assigned into intervention or control groups. The patients in the intervention groups received Yoga therapy for a period of 3 months, eight 1-1.5 hour sessions per month. Severity of fatigue and quality of life were measured by using a standard questionnaire and MSQoL-54 questionnaire, respectively, and compared between the groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104266303N1
Registration date: 2011-05-07, 1390/02/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-05-07, 1390/02/17
Registrant information
Name
Shahla Najafi doulatabad
Name of organization / entity
University of medical science
Country
Iran (Islamic Republic of)
Phone
+98 74 1223 4115
Email address
najafi.shahla@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasouj University of Medical Sciences
Expected recruitment start date
2008-08-17, 1387/05/27
Expected recruitment end date
2010-12-20, 1389/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of yoga exercise on fatigue severity and quality of life of patients with Multiple Sclerosis
Public title
The effect of yoga on MS
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: no other diseases such as: epilepsy, cardio-vascular, metabolic, or psychiatric diseases, having at least 14 years old, at least two years history of being affected to MS disease, ability to do Yoga exercises Exclusion criteria: being at the acute stage of the disease, simultaneous performing of other self-care programs effective on the quality of life
Age
From 14 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yasouj University of Medical Sciences, Ethics committee
Street address
Yasouj University of Medical Sciences, Yasuj
City
Yasouj
Postal code
7591958191
Approval date
2008-07-12, 1387/04/22
Ethics committee reference number
5/22/4/87

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
fatique
Timepoint
1 month -45 Day- 3 month
Method of measurement
questioner

2

Description
quality of life
Timepoint
Baseline and 1 month, 45 days, and 3 months later
Method of measurement
MSQoL-54 questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Yoga therapy for a period of 3 months, each month included eight 1-1.5 hour sessions
Category
Behavior

2

Description
No intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Yasuj University of Medical Sciences
Full name of responsible person
Shahla najafi
Street address
Nursing & midwifery college, Emam Sajad hospital, Yasouj, Iran
City
Yasouj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Haibatallah Sadeghi
Street address
Nursing and midwifery faculty, Emam Sajad hospital, Yasouj
City
Yasouj
Grant name
ندارد
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Shahla Najafi Doulatabad
Position
MSc
Other areas of specialty/work
Street address
Nursing and midwifery faculty, Emam Sajad hospital, Yasouj
City
Yasouj
Postal code
7591958191
Phone
+98 74 1223 4115
Fax
+98 74 1223 4115
Email
najafi.shahla@yums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Shahla Najafi Doulatabad
Position
MSc
Other areas of specialty/work
Street address
Nursing and midwifery faculty, Emam Sajad hospital, Yasouj
City
Yasouj
Postal code
7591958191
Phone
+98 74 1223 4115
Fax
+98 74 1223 4115
Email
najafi.shahla@yums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Shahla Najafi
Position
MSc
Other areas of specialty/work
Street address
Nursing and midwifery faculty, Emam Sajad hospital, Yasouj
City
Yasouj
Postal code
7591958191
Phone
+98 74 1223 4115
Fax
+98 74 1223 4115
Email
najafi.shahla@yums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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