Restless legs syndrome (RLS) is a sensorimotor disorder that is characterized by motor restlessness resulting in an uncontrolled urge to move the affected body parts.RLS symptoms often worsen in long sitting and rest, such as prolonged sleep and during dialysis. Generally the symptoms of restless leg syndrome in renal patients is more common and more severe and causing reduced sleep duration, sleep disruption and reduced quality of life. Since the symptoms of this syndrome occurs or gets worse during the period of immobilization, mild exercise such as stretching can relieve symptoms of restless leg syndrome.This study is a clinical trial to evaluate the impact of intradialytic stretching on symptoms of restless leg syndromeand and sleep quality in hemodialysis patients.in Hashemi Nejad hospital in Tehran, Iran. 36 patients will be diagnosed with RLS symptoms as defined by the standard criteria and
recruited for being part of the study. The recruited patients will be offered the option to exercise (Ex-group) or not to exercise (Con-group) for the period of 8 weeks. Stretching exercises will be performed 3 times a weeks, 30 minutes each time for the last two hours of dialysis. Sleep quality and restless legs syndrome severity will be assessed using the Pittsburgh Sleep Quality questionnaires and International RLS (IRLS)study group rating scale at baseline, weeks 4 and at the end of the study.
General information
Acronym
Restless Legs Syndrome
IRCT registration information
IRCT registration number:IRCT201202182226N9
Registration date:2012-11-19, 1391/08/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-19, 1391/08/29
Registrant information
Name
Mansooreh Aliasgharpour
Name of organization / entity
Nursing & midwifery faculty, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 7120
Email address
aliasgha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-10-06, 1391/07/15
Expected recruitment end date
2012-10-21, 1391/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Intradialytic Stretching Exercise On Severity Of Symptoms Of Restless Legs Syndrome And Quality Of Sleep In Hemodialysis Patients
Public title
The Effect Of Exercise On Severity Of Symptoms Of Restless Legs Syndrome And Quality Of Sleep In Hemodialysis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: answering "yes" to the first four questions of the restless leg syndrome questionnaire; age over 18-dialysis; 3 times a week and 3 or 4 hour hemodialysis each time; no mental and physical disabilities; having full awareness; listening and speaking ability; no infection and ulcers in the legs-no orthopedic problems; no peripheral neuropathy or vascular problems in legs; restless leg syndrome confirmed by GP. Exclusion criteria: no exercise for three consecutive sessions and six sessions generally.
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
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 committee nursing&midwifery Tehran University of Medical Sciences
Street address
squar toohid-nursing&midwifery facultyTehran University of Medical Sciences-tehran-iran
City
tehran
Postal code
1419733171
Approval date
2012-09-09, 1391/06/19
Ethics committee reference number
130/1235/د
Health conditions studied
1
Description of health condition studied
Restless legs syndrome
ICD-10 code
G25.8
ICD-10 code description
Other specified extrapyramidal and movement disorders
Primary outcomes
1
Description
Decrease severity of restless leg syndrome symptomes and increase sleep quality after exercise
Timepoint
Before intervention, the end of the 4th week and 8th week
Method of measurement
pittsburgh Questionnaire- International Restless Legs Syndrome Study Group (IRLSSG)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: stretching exercises will be performed three times a week for eight weeks and questionnaires will be completed at the beginning, end of 4th week and 8th week.
Category
Treatment - Other
2
Description
Control group: questionnaires 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
Shahid Hashemi Nejad hospital, Tehran University of Medical Sciences
Full name of responsible person
Mansooreh Aliasgarpour
Street address
valinejad st.-squar vanak- valiasr street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotohi
Street address
Keshavarse bulvar, Ghods street
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
Zahra Abbasi
Position
MSc student of nursing
Other areas of specialty/work
Street address
Nosrat east street -Faculty of nursing and midwifery - Tohid square
City
Tehran
Postal code
Phone
+98 21 8474 1837
Fax
Email
abbasi.zahra93@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansooreh Aliasgarpoor
Position
MSc
Other areas of specialty/work
Street address
Nosrat east street -Faculty of nursing and midwifery - Tohid square
City
Tehran
Postal code
Phone
+98 21 61054
Fax
Email
aliasgha@tums.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
Mansooreh Aliasgharpoor
Position
Faculty member
Other areas of specialty/work
Street address
Nosrat east street -Faculty of nursing and midwifery - Tohid square
City
Tehran
Postal code
Phone
+98 21 61054
Fax
Email
aliasgha@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)