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A clinical trial of the effect of exercise on the severity of restless legs syndrome in hemodialysis patients

Protocol summary

Summary
The aim of this study was to determine the effects of exercise on the severity of restless legs syndrome in hemodialysis patients in Hajar hospital is 2015. In this clinical trial, 50 cases of hemodialysis patients with restless legs syndrome diagnosed through questionnaire and qualified to enter the study are selected. Exercise schedule requires patients to do pedal biking before the dialysis for one month, 3 times a week, each time for 10 minutes. After the exercise program, dialysis using filters for each group was determined in advance. In order to collect information on participants in the scheme, separate cheklist including age, sex, weight before dialysis, type of filter, pump speed, pressure, duration of work by bike will be prepared and after this period, restless leg syndrome in their checked again. Inclusion criteria included a hemodialysis patient whose last dialysis dates back to at least 6 month ago and not having any disorder of the musculoskeletal system that prevents the desired exercise (pedaling a bicycle) above. Exclusion criteria included patient's inability to exercise, patients opt to participate in the study and the impossibility of continuing the study for various reasons such as changing undergo dialysis or death of the patient.

General information

Acronym
RLS
IRCT registration information
IRCT registration number: IRCT2016021926643N1
Registration date: 2016-06-02, 1395/03/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-02, 1395/03/13
Registrant information
Name
Narges Abaszadeh Dehkordy
Name of organization / entity
Islamic Azad University ، Isfahan unit (Khorasgan)
Country
Iran (Islamic Republic of)
Phone
+98 38 3335 1671
Email address
abaszadeh1393@gmail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-03-01, 1394/12/11
Expected recruitment end date
2016-03-10, 1394/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial of the effect of exercise on the severity of restless legs syndrome in hemodialysis patients
Public title
The effect of an exercise program on the severity of restless legs syndrome in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included a hemodialysis patient whose last dialysis dates back to at least 6 month ago and not having any disorder of the musculoskeletal system that prevents the desired exercise (pedaling a bicycle) above. Exclusion criteria included patient's inability to exercise, patients opt to participate in the study and the impossibility of continuing the study for various reasons such as changing undergo dialysis or death of the patient.
Age
To 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

1

Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30

Ethics committees

1

Ethics committee
Name of ethics committee
Bio-medical research ethics committee of the University of Isfahan University of Medical Sciences
Street address
Isfahan
City
Isfahan
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.NUI.REC.1394.4.130

Health conditions studied

1

Description of health condition studied
Restless Legs Syndrome
ICD-10 code
G25.8
ICD-10 code description
Restless Legs Syndrom

Primary outcomes

1

Description
the severity of restless legs syndrom
Timepoint
before intervention - after intervention
Method of measurement
restless legs syndrom questionnaire

Secondary outcomes

1

Description
Timepoint
Method of measurement

Intervention groups

1

Description
Exercise schedule requires patients to do pedal biking before the dialysis for one month, 3 times a week, each time for 10 minutes. After the exercise program, dialysis using predefined filters is done for each group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrekord Hajar Hospital
Full name of responsible person
Narges Abaszadeh Dehkordy
Street address
Street Sport
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Narges Abaszadeh Dehkordi
Street address
No. 20, Alley 30, Street Sport
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Isfahan Azad University(khorasgan)
Full name of responsible person
Narges Abaszadeh Dehkordy
Position
Graduate student medical-surgical nursing
Other areas of specialty/work
Street address
No. 20, Alley 30, Street Sport
City
Shahrekord
Postal code
8815856979
Phone
+98 38 3335 1671
Fax
Email
abaszadeh1393@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan Azad University(khorasgan)
Full name of responsible person
Gholamhossein Abdeyazdan
Position
Master of nursing
Other areas of specialty/work
Street address
Isfahan Azad University(khorasgan)
City
Isfahan
Postal code
Phone
+98 31 3535 4001
Fax
Email
gabdeyazdan@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan Azad University(khorasgan)
Full name of responsible person
Narges Abaszadeh Dehkordy
Position
Graduate student medical-surgical nursing
Other areas of specialty/work
Street address
No. 20, Alley 30, Street Sport
City
Shahrekord
Postal code
8815856979
Phone
+98 38 3335 1671
Fax
Email
abaszadeh1393@gmail.com
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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