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The effect of yoga on the severity of restless legs syndrome in patients with type 2 diabetes in Tohid Hospital diabetic clinic 2017

Protocol summary

Study aim
Determining the effect of yoga on severity of restless legs syndrome in type 2 diabetic patients in diabetes clinic in Sanandaj, 2016
Design
In this research, 114 patients with type 2 diabetes who have restless leg syndrome who go to the Diabetes Clinic were chosen. They are randomly assigned to two groups of control and intervention by Allocate Subjects with Stats Direct
Settings and conduct
he location of the research is the diabetes clinic in Tohid Hospital in Sanandaj. Before the intervention, restless intensity was measured in two groups of control and intervention, based on the standard questionnaire, 10 questions were asked for each patient individually. Then, in the intervention group, they will be trained and practiced during the 60-minute sessions once a week for 8 weeks in 60-minute sessions and they will be given a homework program for each week. At the end of 8 weeks, the rest is measured in two groups of restless leg strength. Study without blindness.
Participants/Inclusion and exclusion criteria
Inclusion criteria: type 2 diabetes, insulin free, infection with restless leg syndrome, age 18-65, ability to do yoga exercises, absence of other chronic severe conditions Non-compliance criteria: changes in the general condition of the body during the exercise, unwillingness to continue exercises, having a mental disorder, severe seizure of blood glucose
Intervention groups
Case group: A group of people with type 2 diabetes and restless leg syndrome, in which yoga exercises are performed. Control group: There is no intervention in people with type 2 diabetes and restless leg syndrome
Main outcome variables
severity of restless legs syndrome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170815035723N2
Registration date: 2018-01-27, 1396/11/07
Registration timing: registered_while_recruiting

Last update: 2018-01-27, 1396/11/07
Update count: 0
Registration date
2018-01-27, 1396/11/07
Registrant information
Name
Ghazal Mohamadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3328 0637
Email address
ghazal.mohamadi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of yoga on the severity of restless legs syndrome in patients with type 2 diabetes in Tohid Hospital diabetic clinic 2017
Public title
The effect of yoga on the severity of restless legs syndrome in patients with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
type 2 diabetes insulin free consumption restless leg syndrome, based on the questionnaire for 4 questions for screening restless leg syndrome Age between 18 and 65 years Learning and ability to do yoga exercises non-use of other therapies lack of other chronic diseases and heart disease
Exclusion criteria:
any change in the general condition of the body during exercise unwillingness to continually perform exercises during the study reluctance to continue to participate in research having a mental disorder severe hypoglycemia،seizure، coma and death of the patient
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 57
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization, individual randomization unit, and assignment of samples in the group are done using the random allocation method in Randomized with seed: 2498 Allocate Subjects with Stats Randomization. How to construct the random sequence of the quadrilateral block.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data by the researcher is entered into the spss software and the statistical consultant analyzes the data without knowing how the data is entered. Therefore, this study is blinded by statistical counseling on one side.
Placebo
Not used
Assignment
Parallel
Other design features
Participants in the study were two groups of test and control. Participants in the test group received one type of intervention and compared with the control group who had no intervention at the end of the study.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Medical Research and Training Hospital Tohid, Hospital Blvd.Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2017-07-10, 1396/04/19
Ethics committee reference number
IR.MUK.REC.1396/104

Health conditions studied

1

Description of health condition studied
Restless Legs Syndrome
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Restless Legs Syndrome
Timepoint
Before the intervention, eight weeks after the intervention
Method of measurement
Restless Legs Syndrome Rating Scale

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group": intervention in the intervention group includes eight weeks of yoga exercise. Patients undergo yoga exercise training once a week for 60 minutes under the supervision of a yoga instructor under the yoga exercise training program, and for doing daily workouts at home, pamphlets A weekly training program that includes a work picture and a brief description of each exercise is received at the end of each session. In addition, to inform the researcher of home training sessions, patients receive home registry checklists containing the number, time, the name of the exercise The column for the name of the week is given and the checklist filled in each session is visible to the researcher Wahid has arrived. Before the onset of the intervention and after the end of the eighth week, the intensity of restless leg syndrome will be measured using the "Restless Pain Standard Inventory".
Category
Treatment - Other

2

Description
Control group: Before the onset of the study, the severity of restless leg syndrome was measured using the "standard restless leg strength" questionnaire, and the patients received routine treatment without any intervention, and at the end of the eighth week, the severity of restless leg syndrome It is measured and compared with the intervention groupup:
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic of Tohid Hospital in Sanandaj
Full name of responsible person
Mohamad Fathi
Street address
Geryashan Blvd-Tohid Hospital
City
Sanandaj
Province
Kurdistan
Postal code
6616812131
Phone
+98 87 3328 6112
Email
ghazalmohamadi85@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Farzin Razaai
Street address
Medical Research and Training Hospital Tohid, Hospital Blvd.Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
6616813131
Phone
+98 87 3323 5445
Email
ghazalmohamadi85@yahoo.com
Grant name
1396
Grant code / Reference number
1396
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ghazal Mohamadi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kurdistan University of Medical Sciences, lower than Quds Hospital, St.pasdaran, sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3323 5445
Email
ghazalmohamadi85@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Mohamad Fathi
Position
Nursing phd
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kurdistan University of Medical Sciences, lower than Quds Hospital, St.pasdaran, sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3323 5445
Email
fathi_sanan@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ghazal Mohamadi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kurdistan University of Medical Sciences, lower than Quds Hospital, St.pasdaran, sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3323 5445
Email
ghazalmohamadi85@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Part of the data related to the questionnaire of the severity of restless leg syndrome before and after intervention in the two groups after unidentifiable individuals
When the data will become available and for how long
Starting the access period from 1399
To whom data/document is available
Available only to researchers working in academic and academic institutions
Under which criteria data/document could be used
Just to study the data
From where data/document is obtainable
Ghazal Mohammadi General Respondent Email ghazalmohamadi85@yahoo.com
What processes are involved for a request to access data/document
Call us at 00988732579 or email ghazalmohamadi85@yahoo.com
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