Investigating balance exercises on improving indicators related to functional balance in chronic hemodialysis patients
Investigating the effectiveness of walking exercises and strengthening the lower limbs on reducing the risk of falling in chronic kidney patients
Investigating the effectiveness of balance exercises on reducing the risk of falling in chronic kidney patients
Design
This study is conducted on 40 dialysis patients who are divided into two control and intervention groups by simple randomization. This study is a single-blind study.
Settings and conduct
Hemodialysis patients of Loghman Hakim Hospital are referred to the sports medicine clinic of the hospital based on the entry criteria by the kidney specialist and the personnel of the dialysis department. then the patients are randomized based on a simple table of numbers, and the patients undergo the necessary evaluations in the clinic, and both groups are given the necessary recommendations to improve physical activity. In addition the intervention group receives the Otago exercise program and both groups are re-evaluated after 4 weeks.
Participants/Inclusion and exclusion criteria
ESRD patients undergoing chronic hemodialysis were included in the study with the inclusion criteria of age 18 to 70 years, a history of dialysis for more than one year, no history of recent surgery less than two weeks ago, the ability to walk and stand without assistance, and the exclusion criteria were not Availability, lack of sugar or blood pressure control, lack of ability and cooperation in doing exercises properly, kidney transplant are excluded from the study.
Intervention groups
The intervention group receives the exercise program to improve balance
Main outcome variables
The muscle strength of the patients and the static and dynamic balance of the patients are evaluated
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230503058061N1
Registration date:2024-05-08, 1403/02/19
Registration timing:retrospective
Last update:2024-05-08, 1403/02/19
Update count:0
Registration date
2024-05-08, 1403/02/19
Registrant information
Name
fatemeh pourmahdigholi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4477 1359
Email address
fpurmahdigholi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-05, 1402/12/15
Expected recruitment end date
2024-05-04, 1403/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Of Otago Fall Prevention Exercises On Patients Undergoing Chronic Hemodialysis
Public title
The effect of exercise on fall prevention in ESRD patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ESRD patients undergoing chronic hemodialysis
A history of dialysis for more than one year
Not having a history of recent surgery less than two weeks ago
Ability to walk and stand without assistance
Age 18 - 70 years old
Exclusion criteria:
Lack of availability
Lack of control of blood sugar or blood pressure
Lack of ability and cooperation in doing exercises correctly
Undergoing kidney transplantation
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individualized randomization with a table of randomized numbers, the individual is randomly placed in one of two groups based on a number before the patient enters the clinic. After being referred by a nephrologist, people are divided into odd and even numbers based on the entry criteria after making an appointment at the sports medicine clinic, those with odd numbers are in the intervention group and those with even numbers are in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The personnel who refer the patients do not know which patient is in which group. The person who performs the initial evaluation of people does not know about the group of the person.
The person who will interpret the statistics does not know about the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti university of medical sciences
Street address
Ethics committee of shahid beheshti university of medical sciences , koodakyar St, DaneshjooBlvd ,Velenjak ,
4-step balance test in the form of standing time of the patient in the position of two legs. single leg , tandem and feet behind each other.
2
Description
Endurance of lower limb muscles
Timepoint
At the beginning and the end of 4 weeks
Method of measurement
30 seconds seat to stand test
3
Description
Dynamic balance
Timepoint
At the beginning and the end of 4 weeks
Method of measurement
Time up and go test
4
Description
Fall risk
Timepoint
At the beginning and the end of 4 weeks
Method of measurement
Fall risk test using Biodex device
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The group includes 20 chronic hemodialysis patients who receive the routine physical activity program
Category
Lifestyle
2
Description
Intervention group: 20 chronic hemodialysis patients receive an exercise program in addition to routine physical activity recommendations to reduce the risk of falling. This program includes a combination of balance exercises: strength and aerobics. Aerobic exercises include regular walking, balance exercises include standing on one leg walking backward, and walking on the 8 path. Strength exercises include strength exercises of the lower limbs, which are set in a 10-exercise program of the Otago exercise therapy protocol. Exercises are performed for one month and after one month they are re-evaluated in terms of balance and risk of falling.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Fatemeh Pourmahdigholi
Street address
Loghman Hakim Hospital ,Makhsoos St , Horr Sq
City
Tehran
Province
Tehran
Postal code
1234756890
Phone
+98 21 5541 9005
Email
fpurmahdigholi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University Of Medical Sciences ,Koodakyar St , Daneshjoo Blvd , Velenjak
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 23871
Email
fpuemahdigholi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Pourmahdigholi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Ayat Allat Taleghani Hospital , daneshjoo street, tehran
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 4477 1359
Fax
Email
fpurmahdigholi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Pourmahdigholi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Ayat Allat Taleghani Hospital , Daneshjoo Street, Tehran
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 4477 1359
Fax
Email
fpurmahdigholi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Pourmahdigholi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Ayat Allat Taleghani Hospital , Daneshjoo Street, Tehran
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 4477 1359
Fax
Email
fpurmahdigholi@gmail.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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
No data
When the data will become available and for how long
never
To whom data/document is available
no one
Under which criteria data/document could be used
No one
From where data/document is obtainable
No source
What processes are involved for a request to access data/document