Protocol summary

Study aim
Determining The effect of Otago exercise on balance and fanctional status in hemodialysis pateints
Design
Randomized clinical trial with control and interventional group, available sampling
Settings and conduct
- All patients undergoing hemodialysis, Imam Ali Bojnourd Hospital -Accidental allocation of patients in couple of days in two shifts in the morning and evening to the intervention group and patients from odd days to control group to prevent contamination of the groups together - Exercise Otago for eight weeks - Measurement of motor balance, functional status before intervention, eight weeks and three months after training in both intervention and control groups
Participants/Inclusion and exclusion criteria
Entry requirements : Chronic Kidney Disease, no history of falls, age range of 18to 75years, three sessions per week dialysis, hemodialysis history for at least 1 year, Adequacy of dialysis equal to 1.2 or higher, hemoglobin higher than 10 g / dL, person's ability to walk, no exist Musculoskeletal problems Exit requirements: Unwillingness to continue the study, disconnect with the researcher, kidney transplantation, incidence of any heart disease during the study, increased blood pressure, stopping more than three continuous sessions, patient death
Intervention groups
For the intervention group, Otago sports will be taught. This program includes retraining power and balance with walking. This program lasts three times a week and lasts about 30 minutes each time & send to walking two times per week. After training, Otago sports exercises continuously at home ( no dialysis day) Is done in a period of 8 weeks. During the whole period of the study, the control group will continue to function normally.
Main outcome variables
-Improve motor function and motor balance in patients undergoing hemodialysis -Supporting hemodialysis patients for independence in everyday activities

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180416039320N1
Registration date: 2018-05-18, 1397/02/28
Registration timing: prospective

Last update: 2018-05-18, 1397/02/28
Update count: 0
Registration date
2018-05-18, 1397/02/28
Registrant information
Name
Zahra Ghorbanalinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3225 2040
Email address
z-ghorbanalinejad@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-05, 1397/03/15
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Otago exercise on improving motor balance and functional status of hemodialysis patients
Public title
The effect of Otago exercise in balance and fanctional status
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have chronic kidney dis (CKD) Not having a history of collapse has caused serious damage in the past Age range (aged 75-89) Perform three sessions per week for dialysis Having a history of hemodialysis for at least 1 year Adequacy of dialysis= ​​1.2 or higher Hemoglobin level higher than 10 g / dl The ability of a person to walk with or without a crutch and no need for moving aids for eaxample walker and wheelchair Lack of musculoskeletal problems in the lower extremities, such as significant muscle weakness, severe arthritis, history of hip fracture, which exercise obstacles Residence in Bojnord Access and ability to use a cell phone and telegram by the patient or caregiver to provide educational communication and reminder to the patient to perform OTAGO at home
Exclusion criteria:
Unwillingness to continue participating in the study Disconnect with the researcher Performing a kidney transplant The occurrence of any type of heart disease during the study that requires absolute rest and is inconsistent with exercise exercises Un control of the patient's blood pressure Traveling to nearby cities to continue treatment or leave your home for more than a week A patient that stops more than three sessions continuous (one week) Patient's death
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, individual, based on package insert Patients that come to dialysis in morning & afternoon couple days randomized to intervention group and Patients that come to dialysis in morning & afternoon odd days randomized to control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Keshavarz Blvd.Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-04-13, 1397/01/24
Ethics committee reference number
IR.TUMS.FNM.REC.1397.4948

Health conditions studied

1

Description of health condition studied
Patient undergoing hemodialysis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Balance Score in the tests used in the research
Timepoint
Measurement of motor balance at the beginning of the study(Before the intervention begins)،2 months after the intervention،3 months after the completion of the Otago exercise
Method of measurement
Berg Balance Scale ،Four-Stage Balance Test،Katz Index of Independence in Activities of Daily Living

2

Description
Functional status Score in the tests used in the research
Timepoint
Measurement of fanctional status at the beginning of the study(Before the intervention begins)،2 months after the intervention،3 months after the completion of the Otago exercise
Method of measurement
Berg Balance Scale ،Four-Stage Balance Test،Katz Index of Independence in Activities of Daily Living

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Rehabilitation

2

Description
Control group:
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Zahra Ghorbanalinejad
Street address
Doctor Hesabi Ave., Imam Ali Hospital
City
Bojnourd
Province
North Khorasan
Postal code
7487794149
Phone
+98 58 3222 1910
Email
INFO@NKUMS.AC.IR

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology of Tehran University of Medical Sciences
Street address
Keshavarz Blvd.Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Fax
+98 21 8163 3611
Email
rmo@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Ghorbanalinejad
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Keshavarz Blvd.Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 58 3225 2040
Email
z-ghorbanalinejad@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Ghorbanalinejad
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Keshavarz Blvd.Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 58 3225 2040
Email
z-ghorbanalinejad@razi.tuma.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Ghorbanalinejad
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Keshavarz Blvd.Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 58 3225 2040
Email
z-ghorbanalinejad@razi.tums.ac.ir

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
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