The aim of this study was to determine the effect of stretching exercises on restless leg syndrome and quality of sleep in patients with multiple sclerosis. In this clinical trial, 50 patients with multiple sclerosis Kermanshah city who have inclusion criteria were selected randomly in two groups stretching exercises (test) and control. Tools used"International group of restless leg syndrome", "Pittsburgh Sleep Quality Index," "Scale rating of restless leg syndrome", "Exercise record sheets". Severity of restless leg syndrome and sleep quality will be measured terminals Before intervention and the end of the fourth week and eighth week. Inclusion criteria included: patients are with restless leg syndrome have؛ full consciousness؛ not in the stage of acute and chronic multiple sclerosis؛ not in the stage of acute and chronic multiple sclerosis؛ they are able to do stretching exercises؛ do not consume hypnotic drug and affecting leg syndrome restless. exclusion criteria included: no exercise for three consecutive sessions and six sessions generally.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041627427N1
Registration date:2016-05-23, 1395/03/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-23, 1395/03/03
Registrant information
Name
Maryam Ayarehgar
Name of organization / entity
shahid Beheshti Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 83 3839 8441
Email address
m.eyarehgar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Committee Shahid Beheshti University of Medical Sciences, School of Nursing and Midwifery
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of stretching exercises on Restless leg syndrome and sleep quality in patients with multiple sclerosis.
Public title
Stretching the effect of RLS and sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients are with restless leg syndrome؛ have full consciousness؛ not in the stage of acute and chronic multiple sclerosis؛ they are able to do stretching exercises؛ do not consume hypnotic drug and affecting leg syndrome restless.
The exclusion criteria were: lack of exercise for 3 consecutive days and six general meeting
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics CommitteeShahid Beheshti University of Medical Sciences Faculty of Nursing and Midwifery
Street address
Shahid Beheshti Faculty of Nursing and Midwifery, Niyayesh Intersection, Valiasr Aveniue
City
Tehran
Postal code
22439914
Approval date
2015-10-23, 1394/08/01
Ethics committee reference number
IR.SBMU.PHNM.1394.185
Health conditions studied
1
Description of health condition studied
Restless Leg Syndrome
ICD-10 code
G25.8
ICD-10 code description
Other specified extrapyramidal and movement
Primary outcomes
1
Description
severity of RLS symptoms
Timepoint
Before the intervention, the end of the fourth week, the end of the eighth week
Method of measurement
"Restless leg syndrome rating scale"
2
Description
Sleep Quality
Timepoint
Before the intervention, the end of the fourth week, the end of the eighth week
Method of measurement
"Pittsburgh Sleep Quality Index"
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental group, Stretching exercises will be performed three times a week for eight weeks and questionnaires"Pittsburgh Sleep Quality Index" and "evaluate the severity of symptoms of restless leg syndrome" will be completed the begging, end of 4th week and 8th week
Category
Other
2
Description
The control group questionnaires" Pittsburgh Sleep Quality Index and "evaluate the severity of symptoms of restless leg syndrome" will be completed at the beginning, end of 4th week and 8th week. No intervention for the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Association of Multiple Sclerosis Patients
Full name of responsible person
Maryam Ayarehgar
Street address
108 alley,Nith Avenue, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research, School of Nursing and Midwifery shahid Beheshti
Full name of responsible person
Amirhosayn Barbaz Esfahani
Street address
Shahid Beheshti Faculty of Nursing and Midwifery, Niyayesh Intersection, Valiasr Aveniue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for research, School of Nursing and Midwifery shahid Beheshti
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 Beheshti Faculty of Nursing and Midwifery
Full name of responsible person
Mimanat Hosseini
Position
Assitant professor PHD
Other areas of specialty/work
Street address
Shahid Beheshti Faculty of Nursing and Midwifery, Niyayesh Intersection, Valiasr Aveniue
City
Tehran
Postal code
22439914
Phone
+98 21 8865 5366
Fax
Email
meimanathosseini@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
shahid Beheshti Faculty of Nursing and Midwifery
Full name of responsible person
Meimant Hosseini
Position
Assistant Professor PHD
Other areas of specialty/work
Street address
Shahid Beheshti Faculty of Nursing and Midwifery, Niyayesh Intersection, Valiasr Aveniue
City
Tehran
Postal code
22439914
Phone
+98 21 8865 5366
Fax
Email
meimanathosseini@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Maryam Ayarehgar
Position
ms nursing
Other areas of specialty/work
Street address
108 alley, Ninth Avenue, Kermanshah
City
Kermanshah
Postal code
6714697614
Phone
+98 83 3839 8441
Fax
Email
maryamayaregar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)