Protocol summary

Summary
This research has been conducted to evaluate the comparison of stretching with aerobic& aerobics exercise on fatigue levels in Multiple Sclerosis patients in randomized, double blind design . this research involving 80 patients Selected with no probability convenience sampling according to specific criteria(Age range was between 45-20 years,The disease by medical experts and Results of diagnostic tests including MRI was confirmed, at least had the literacy, Ability to understand conversation in Farsi, severe stage of disease were not, about one year from onset disease was last (the opportunity to cope with disease).patients haven't Any underlying disease such as Orthopedic problems, heart disease,The scale of severity of disability (Expanded Disability Status Scale) was between 5/5-0 ). Exclusion criteria : those who did not exercise them regularly and if for any reason before the acute phase of illness, and people can not continue exercise, The data gathering tools were questionnaire includes demographic variables, disease data & fatigue severity scales (FSS). Exercise was done for 18 sections. After exercise session's period they completed questionnaire (level of fatigue) again. There are significant difference between two intervention groups in pretest.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203069219N1
Registration date: 2012-04-01, 1391/01/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-04-01, 1391/01/13
Registrant information
Name
Marzieh Pazokian
Name of organization / entity
Baqiyatallah Faculty of Nursing
Country
Iran (Islamic Republic of)
Phone
+98 21 3319 5038
Email address
h_pazokian@iust.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2007-10-23, 1386/08/01
Expected recruitment end date
2008-07-27, 1387/05/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of stretching with aerobic &aerobic exercise on fatigue level in Multiple Sclerosis patients
Public title
The effect of exercise on fatigue level
Purpose
Supportive
Inclusion/Exclusion criteria
Age range was between 45-20 years;The disease by medical experts and Results of diagnostic tests including MRI was confirmed; at least had the literacy, Ability to understand conversation in Fars;patients were not in severe stage of disease;about one year from onset disease was last (the opportunity to cope with disease);patients haven't Any underlying disease such as Orthopedic problems, heart disease;The scale of severity of disability (Expanded Disability Status Scale) was between 5/5-0 . Exclusion criteria :those who age was less than 20 years and have over 45 years;patients that have diseases expect of MS, thosethat can not read and write and speak the Persian language; less than 1 year of onsetdisease is past; their disability severity scale is not between0- 5/5; those who did not exercise them regularly and if for any reason before the acute phase of illness; and people can not continue exercise
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Tehran University of Medical Sciences
Street address
Tehran
City
Tehran
Postal code
Approval date
2008-09-08, 1387/06/18
Ethics committee reference number
132/130/ص

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Diseases of the nervous system

Primary outcomes

1

Description
FATIGUE
Timepoint
0-18
Method of measurement
Fatigue Severity Scales (questionnaire)

Secondary outcomes

1

Description
Fatigue
Timepoint
0-18
Method of measurement
Fatigue Severity Scale(questionnaire)

Intervention groups

1

Description
Intervention groups: group 1 : 30 min aerobic exercise (include, walking on a treadmill with a speed of 1 meter per second, jogging and bike handling each 10 minute
Category
Rehabilitation

2

Description
group 2:streching stretching with aerobic exercise that include hip, neck etc stretching 15 min post 30 min aerobic exercise (total 45) were performed for 18session One day
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
MS center
Full name of responsible person
Pazokian, Marzieh
Street address
Vesal street, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pazokian
Street address
Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Pazokian
Position
MS Of Nursing
Other areas of specialty/work
Street address
Tehran
City
Number4,Perozi street, tajeri street,Tehran, Iran
Postal code
Phone
+98 912 685 1924
Fax
Email
h_pazokin@iust.ac.irmpazokian@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
TUMS.ac.ir
Full name of responsible person
Pazokian
Position
Master Science
Other areas of specialty/work
Street address
tehran
City
tehran
Postal code
Phone
+98 912 685 1924
Fax
Email
h_pazokian@iust.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pazokian,Marzieh
Position
MS Of Nursing
Other areas of specialty/work
Street address
Number 4,tajeri street. pirozie street , Tehran,Iran
City
Tehran
Postal code
1764877431
Phone
00
Fax
Email
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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