The effect of visual and balance exercises on motor function and quality of life of hemodialysis patients.
Design
The clinical trial has a control group and three intervention groups that include vision exercises, balance exercises and combined exercises. The randomization method of this intervention is simple, which will be performed on 110 patients, which will be blinded on one side, and the randomization will be used by Statacrop software .
Settings and conduct
The clinical trial has a control group and three intervention groups of vision exercises, exercises and combined exercises. Simple on 110 patients is blinded on one side and randomized program will be used by Statacrop computer.
Participants/Inclusion and exclusion criteria
Inclusion criteria:undergoing HD for at least 1 year and agreeing to participate, Exclusion criteria: having medical contraindications for exercise .
Intervention groups
Vision training group, balance training group, combined training group, all groups will attend three sessions a week for 12 weeks for one hour each session, and the control group will be without intervention and only pre-test and post-test will be taken from them.
Main outcome variables
Motor Function; Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220809055648N1
Registration date:2023-05-08, 1402/02/18
Registration timing:registered_while_recruiting
Last update:2023-05-08, 1402/02/18
Update count:0
Registration date
2023-05-08, 1402/02/18
Registrant information
Name
Mahboobeh Hosini sarbazu
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 0506
Email address
m.h.sarbazi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-08-06, 1402/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of vision, balance and combined exercises on motor function and quality of life of hemodialysis patients
Public title
The effect of vision, balance and combined exercises on motor function and quality of life of hemodialysis patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 80 years
More than 1 year of dialysis experience
Having a three-time hemodialysis program
No heart attack and stroke in the past three months
Having the ability to communicate with others
The permission of the attending physician to practice
Exclusion criteria:
unstable heart condition (angina, congestive heart failure, severe arterial stenosis) during exercise
Active infection or acute medical illness during intervention
Hemodynamic instability during intervention
Unstable blood sugar during intervention
Unable to do exercises, after a few sessions of participating
Having severe musculoskeletal pain during exercises
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, individual with random number generation program
Randomization was performed by a biostatistician using a computer-generated randomization program [using Stata 16, StataCrop, College Station, Tx] (regarding number of groups) with an allocation ratio of 1:1:1:1.
For allocation concealment, allocation information will be protected in opaque sealed envelopes by an identified individual not participating in the study. Only after participant registration and baseline measurements are completed will envelopes be opened.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the intervention, it is not plausible to blind participants and study staff
who enroll participants and monitor the intervention delivery.
Research project collaborator who is blinded to
study arm assignments will obtain outcome measurements of the functional test and abnormalities. Outcome
adjudicators, and data analysts will be kept blinded to the allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Azad University of Khorasgan Branch
Street address
University Blvd, Arghavanieh Ave, Estern Jey Str, Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
8155139998
Approval date
2022-09-14, 1401/06/23
Ethics committee reference number
IR.IAU.KHUISF.REC.1401.204
Health conditions studied
1
Description of health condition studied
End stage renal disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
motor performance
Timepoint
Before starting exercise and three months later
Method of measurement
6-minute walk test, Berg balance test, Timed up and Go test
Secondary outcomes
1
Description
Quality of life
Timepoint
Before starting exercise and three months later
Method of measurement
The standard questionnaire of the quality of life for kidney patients
Intervention groups
1
Description
Intervention group: The group of balance exercises, three sessions per week for 12 weeks ( each for 1 hour) includes stretching exercises (neck stretching, arm and hand stretching, shoulder rotation and vertical movement, lateral stretching, single knee stretching, leg stretching) which Taken from Pinter's studies at the Medical Education Institute, it is an empowering resource. and balance exercises taken from the studies of Bennett, Lingard and Maxwell (2015), which include (chest press, shoulder press, triceps strengthening, straight arm stretch, horizontal shoulder stretch, back grip, palmar grip, biceps rotation, rotation leg press, calf press, leg press in a straight position, leg press in bent knee position, hip pull, straight leg lift, drawing letters with feet in the air, pulling knees in the stomach).
Category
Rehabilitation
2
Description
The vision training group, which has three sessions (each for 1 hour) per week for 12 weeks, will do vision exercise which includes saccadic eye movements and tracking.
Category
Rehabilitation
3
Description
Intervention group: Combined exercises for 12 weeks, three sessions per week ( each for 1 hour). The participants will do balance and vision exercises ( each one for half an hour).
Category
Rehabilitation
4
Description
Control group: without exercising
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin Isfahan Hospital Hemodialysis Center
Full name of responsible person
Majid Hosseinzadeh
Street address
Sonbolestan Ave, Ebn Sian Str, Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
5314181486
Phone
+98 31 3445 5051
Email
m.h.sarbazi@gmail.com
2
Recruitment center
Name of recruitment center
Farabi Hospital Hemodialysis Center, Isfahan
Full name of responsible person
Hamid Mohamad Beigi
Street address
Arghavanie Blvd, Mushtaq third Str, Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
8166176141
Phone
+98 31 3531 2020
Email
m.h.sarbazi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Toghiyani
Street address
University Blvd, Arghavanieh Ave, Estern Jey Str, Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
info@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University of Khorasgan, Isfahan
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
Islamic Azad University
Full name of responsible person
Mahbobeh Hosseini Sarbazi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Others
Street address
University Blvd, Arghavanieh Ave, Estern Jey Str, Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m.h.sarbazi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rokhsare Badami
Position
Academic Staff, Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
University Blvd, Arghavanieh Ave, Estern Jey Str, Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
rokhsareh.badami@khuisf.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
zohre Meshkati
Position
Academic Staff, Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
University Blvd, Arghavanieh Ave, Estern Jey Str, Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
815539998
Phone
+98 31 3535 4001
Email
zmeshkati@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of the study group are made available
When the data will become available and for how long
ِِAfter November 2023
To whom data/document is available
Only academics are allowed.
Under which criteria data/document could be used
If the data is used for the purpose of research in the field of variables and providing new solutions, it can be used by mentioning the source.
From where data/document is obtainable
by email
m.h.sarbazi@gmail.com
rokhsareh.badami@gmail.com
zmeshkati@gmail.com
be referred.
What processes are involved for a request to access data/document
It will be answered within one month after receiving the email.