This is a clinical trial carried out in "Azahra", "Noor" and "Ali Asghar" hospitals in Esfahan. Fourteen patients receiving hemodialysis with the following criteria were recruited by simple sampling method: 1.Recieving dialysis for at least 3 month, 2.Existance of characteristics movements of restless leg syndrome, 3.Effective dialysis (kt/v>1) Exclusion criteria: 1.Existance of musculoskeletal disorder that prevents patients from doing the exercise 2. Ischemic heart disease. Patients are randomly divided into exercise and control groups. Those in the intervention group receive an exercise schedule of 30 minutes of peddling by Medi-Bike (Swiss made) between the 2nd and 3rd hour of hemodialysis 3 times a week for 16 weeks. The exercise will not commence or will be stopped immediately in the following circumstances: BP>180/110mmhg or SBP<90mmhg, chest pain or dyspnea, signs of inappropriate tissue perfusion, neurological signs such as dizziness or ataxia. The severity of restless legs syndrome and quality of life will be assessed with RLSQ and SF36 questionnaire respectively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138806082370N3
Registration date:2010-06-16, 1389/03/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-16, 1389/03/26
Registrant information
Name
Mojgan Mortazavi
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1260 2593
Email address
m_mortazavi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Esfahan University of Medical Sciences
Expected recruitment start date
2009-04-04, 1388/01/15
Expected recruitment end date
2009-06-20, 1388/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intradialytic aerobic exercises on restless legs syndrome and quality of life in hemodialytic patients
Public title
The effect of intradialytic aerobic exercises on restless legs syndrome and quality of life in hemodialytic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1. Recieving dialysis for at least 3 month, 2. Existance of characteristics movements of restless leg syndrome, 3. Effective dialysis (kt/v>1)
Exclusion criteria: 1. Existance of musculoskeletal disorder that prevents patients from doing the exercise 2. Ischemic heart disease
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
14
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
Isfahan university of medical science
Street address
vice chancellor for research,Isfahan university of medical science
City
Isfahan
Postal code
Approval date
2017-11-21, 1396/08/30
Ethics committee reference number
387458
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
ُSeverity of restless legs syndrome
Timepoint
Every two week and then every four week
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
At the beginning and the end of study
Method of measurement
Questionnaire
Intervention groups
1
Description
No intervention
Category
N/A
2
Description
Those in the intervention group receive an exercise schedule of 30 minutes of peddling by Medi-Bike (Swiss made) between the 2nd and 3rd hour of hemodialysis 3 times a week for 16 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
"Azahra" and "Noor and Ali Asghar" hospitals in Esfahan
Full name of responsible person
Street address
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research
Street address
Esfahan University of Medical Sciences
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mojgan Mortazavi
Position
Assistant Professor of Nephrology
Other areas of specialty/work
Street address
Internal Medicine Unit, School of Medicine, Esfahan University of Medical Sciences
City
Esfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
m_mortazavi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mojgan Mortazavi
Position
Assistant professor of Nephrology
Other areas of specialty/work
Street address
Internal Medicine Unit, School of Medicine, Esfahan University of Medical Sciences
City
Esfahan
Postal code
Phone
+98 31 1260 2593
Fax
Email
m_mortazavi@med.mui.ac.ir; mojgan520@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Mr Ghasem Pour Soleimani
Position
Medical Student
Other areas of specialty/work
Street address
MirBaghery Dormitory, Esfahan University Dormitories Complex, Hezar JArib St.,
City
Esfahan
Postal code
8174673548
Phone
00983116690024, 00983116692461
Fax
Email
aida_gh1985@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)