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 . Generally the symptoms of restless leg syndrome in diabetic 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 stretching on symptoms of restless leg syndromeand and sleep quality in type 2 diabetic patients in firozgar hospital in Tehran, Iran. 80 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 3 nights. Stretching exercises will be performed 3 nights, 30 minutes each time . Sleep quality and restless legs syndrome severity will be assessed using the Pittsburgh Sleep Quality questionnaires and International RLS (IRLS)study group rating scale for 3 nights after and before intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010725336N3
Registration date:2016-04-22, 1395/02/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-22, 1395/02/03
Registrant information
Name
Zahra Moeini
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 609 0477
Email address
moeini.z@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-11-21, 1394/08/30
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of stretching exercises on the sleep quality of type 2 diabetic patients suffering from restless leg syndrome
Public title
The effect of stretching exercises on the sleep quality of type 2 diabetic patients suffering from restless leg syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: answering "yes" to the first four questions of the restless leg syndrome questionnaire; age over 30- 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
No age limit
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)
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 Iran University of Medical Sciences
Street address
Hemmat West highway between the intersection of Sheikh Fazlullah Nuri martyr and Chamran martyr
City
Tehran
Postal code
Approval date
2015-11-21, 1394/08/30
Ethics committee reference number
IR.IUMS.REC.1394.9221196201
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
3 night before and 3 night after intervention
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 for 3 nights and questionnaires will be completed 3 night before and 3 night after intervention
Category
Other
2
Description
Control group: questionnaires will be completed for 6 night. No intervention for the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Firouzgar Hospital. Iran University of Medical Science.
Full name of responsible person
Fatemeh Mohaddes Ardebili
Street address
Beh Afarin AVenue, Vali Asr Square, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Assistance of Iran University of Medical Sciences
Full name of responsible person
Dr. Nahid Akbari
Street address
Between the intersection of Sheikh Fazlullah Nuri and Shahid Chamran, Shahid Hemmat West Highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistance of Iran 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
Iran university of medical sciences
Full name of responsible person
Seyede Zahra Moeini
Position
Masters Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Rashid Yasami Avenue, Above Mirdamad, Vali Asr Avenue, Tehran
City
Tehran
Postal code
Phone
+98 21 8888 2886
Fax
Email
s.z.moeini88@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Mohaddes Ardebili
Position
master
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Rashid Yasami Avenue, Above Mirdamad, Vali Asr Avenue, Tehran
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
s_mohaddes2005@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sceinces
Full name of responsible person
Seyede Zahra Moeini
Position
Nursing master student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Rashid Yasami Avenue, Above Mirdamad, Vali Asr Avenue, Tehran
City
Tehran
Postal code
Phone
+98 81 3839 8271
Fax
Email
moeini.z@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)