Comparison the effect of cool dialysate and stretching exercises on restless leg syndrome in patients undergoing hemodialysis with chronic renal failure
Comparison the effect of cool dialysate and stretching exercises on restless leg syndrome in patients undergoing hemodialysis with chronic renal failure
Design
Sixty patients with restless leg syndrome are randomly assigned into two groups of cold-dialysis solution and stretching exercises. A study is a double-blind clinical trial with parallel groups.
Settings and conduct
This study will be performed on 30 patients in the experimental group and 30 patients in the control group in the dialysis section at Sabzevar Hospital who have inclusion criteria and will randomly be divided into two groups. In this study , researcher and data analyst will be blinded. For 6 weeks, the experimental group is dialyzed at 35.5 ° C and the control group performs stretching exercises. The restless leg syndrome in both groups will be evaluated with the International restless leg syndrome questionnaire before intervention and at the end of each week
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Patient diagnosed with chronic renal failure who has been undergoing hemodialysis for 3 months. 2. Patients with a minimum hemoglobin of 10 mg / dL
Exclusion criteria: 1. Hearing and visual impairment
2)Taking medication or food that exacerbates restless leg syndrome during dialysis
Intervention groups
Intervention group 1:Among patients with restless leg syndrome, a group of 30 patients is selected as the cold dialysis solution group. And they will undergo cold hemodialysyis (35.5 ° C ) 4 hours at each session, for 6 weeks 3 times a week. Intervention group 2: Among patients with restless leg syndrome, 30 patients undergo stretching exercises and for 6 weeks 3 times a week for half an hour in the first 2 hours of dialysis do stretching exercises. The dialysis temperature for the group is the same as the standard solution temperature (37 ° C).
Main outcome variables
Restless legs syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181108041594N1
Registration date:2019-01-04, 1397/10/14
Registration timing:registered_while_recruiting
Last update:2019-01-04, 1397/10/14
Update count:0
Registration date
2019-01-04, 1397/10/14
Registrant information
Name
Azam Zirakaliabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5584 3407
Email address
ziraka95@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-07, 1397/09/16
Expected recruitment end date
2019-01-17, 1397/10/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of cool dialysate and stretching exercises on restless leg syndrome in patients undergoing hemodialysis with chronic renal failure
Public title
Comparison the effect of cool dialysate and stretching exercises on restless leg syndrome in dialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to participate in the study
Age over 18 and up to 71 years
Patients with a minimum hemoglobin of 10 mg / dL
Patient diagnosed with chronic renal failure who has been undergoing hemodialysis for 3 months
Patients with arteriovenous fistula for hemodialysis
Patients undergoing hemodialysis three times a week and each session are 4 hours
Patients who have had Hemodialysis over the past 2 months have had a history of restless leg syndrome during Hemodialysis
Patients with adequacy of dialysis more or equal 1
Exclusion criteria:
Hearing and visual impairment
Taking medication or food that exacerbates restless leg syndrome during dialysis
Pregnancy and the presence of liver problems
Receiving treatments that are effective on restless leg syndrome during dialysis (complementary medicine, acupuncture and topical conditioners)
The presence of any infection and ulcers in the legs
Having orthopedic problems
Having vascular problems in the lower extremities
Severe mental illness and mood disorder - severe emotional disturbance that prevents effective communication.
Patient with hypercalcemia and hypocalcemia
Age
From 18 years old to 71 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are selected according to the eligibility criteria and then they randomly are assigned in two groups with 30 patients, the stretching exercises group (by performing hemodialysis with dialysis solution temperature 37) and cold dialysate group (performing hemodialysis with dialysis solution 35/5) using the Permutation blocks method. The control group is marked with the letter a and the intervention group with the letter b and the size of each block is 4, and the number of blocks is 15 and the number of possible permutations is 4. Then from the random number table or using the simulation command in the application R (runif(15,min=1,max=4)، fifteen random numbers selected and fill 15 blocks of states.So the first four person who enter the study the first person receiving treatment b, the second treatment a, the third person receiving treatment b, and the fourth person receiving treatment a.second Four person who enter the study the first person receiving treatment b, the second treatment b, the third person receiving treatment a, and the fourth person receiving treatment a . Fifteenth four person who enter the study the first person receiving treatment b, the second treatment a, the third person receiving treatment b, and the fourth person receiving treatment a. In this study Patients are not blind. The researcher will be blinded by completing the questionnaires by researcher assistant. And data analyzers will be blinded by patient encoding.
.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study Patients are not blind.The researcher will be blinded by completing the questionnaires by researcher assistant. And data analyzers will be blinded by patient encoding.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Block B, Pardis of Sabzevar University of Medical Sciences, Road Tohid Shahr
City
Sabzevar
Province
Razavi Khorasan
Postal code
94617-85493
Approval date
2018-11-11, 1397/08/20
Ethics committee reference number
IR.MEDSAB.REC.1397.056
Health conditions studied
1
Description of health condition studied
Restless leg syndrome
ICD-10 code
G25.81
ICD-10 code description
Restless legs syndrome
Primary outcomes
1
Description
Restless legs syndrome
Timepoint
The measurements of restless leg syndrome are at the beginning of the study before the start of the intervention and then at the end of each week after the completion of the dialysis for 6 weeks.
Method of measurement
The severity of restless leg syndrome questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:Among patients with restless leg syndrome, a group of 30 patients is selected as the cold dialysis solution group. And they will undergo cold hemodialysyis (35.5 ° C ) 4 hours at each session, for 6 weeks.
Category
Treatment - Other
2
Description
Intervention group 2: Among patients with restless leg syndrome, 30 patients undergo stretching exercises and for 6 weeks 3 times a week for half an hour in the first 2 hours of dialysis, stretching exercises including pelvic to the sides, Quadriceps muscle stretching, stretching of the muscle of the gluteal muscle , Pulling the hamstrings and pulling the knee to the chest. The dialysis temperature for the group is the same as the standard solution temperature (37 ° C).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Vasei Hospital in Sabzevar
Full name of responsible person
Mostafa Rad
Street address
Pardis of Sabzevar University of Medical Sciences, above the Yadbood of Shohada Gomnam, Boulevard of Tohid
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 51 4401 1000
Fax
+98 51 4401 1013
Email
info@medsab.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshteh Ghorat
Street address
Pardis of Sabzevar University of Medical Sciences, above the Yadbood of Shohada Gomnam, Boulevard of Tohid
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 51 4401 1000
Fax
+98 51 4401 1013
Email
info@medsab.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mostafa Rad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Block B, Pardis of Sabzevar University of Medical Sciences, Road Tohid Shahr
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 51 4401 8314
Fax
Email
mostafarad633@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mostafa Rad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Block B, Pardis of Sabzevar University of Medical Sciences, Road Tohid Shahr
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 51 4401 8314
Fax
Email
mostafarad633@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mostafa Rad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Block B, Pardis of Sabzevar University of Medical Sciences, Road Tohid Shahr
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 51 4401 8314
Fax
Email
mostafarad633@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available