Investigating The Effect of Intradialytic Combined Resistance and Aerobic Exercise on Quality of Life and Related Factors in Hemodialysis Children.
Design
This is a pre-test and post-test study without a control group. All participants will engage in exercise during dialysis.
Settings and conduct
Exercises will be conducted in the hemodialysis unit of Mofid Children's Hospital under the supervision of nephrologists, rehabilitation specialists, and exercise physiologists. Exercises will include resistance training with weights and pedaling using pedals attached to the dialysis chair during the initiation of dialysis and while the child is connected to the hemodialysis machine.
Participants/Inclusion and exclusion criteria
Inclusion criteria the research:
Minimum two months of dialysis history
No history of ischemic heart disease or pulmonary diseases
No musculoskeletal disorders that would prevent exercise
Children aged 8 to 18 years with a stable disease condition
At least two dialysis sessions per week
Exclusion criteria from the research:
Inability to perform exercise
Shortness of breath during exercise
Any heart or lung disease
Intervention groups
Resistance training includes 3 exercises with 10 repetitions using dumbbells or resistance bands, and aerobic training using pedals that can be attached to the dialysis chair. Exercises will be performed during the first 30 minutes of dialysis.
Main outcome variables
Quality of Life؛ Dialysis Adequacy؛ Blood Electrolytes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241012063340N1
Registration date:2024-10-29, 1403/08/08
Registration timing:retrospective
Last update:2024-10-29, 1403/08/08
Update count:0
Registration date
2024-10-29, 1403/08/08
Registrant information
Name
Reza Ghorbani khosroshahi
Name of organization / entity
The University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2285 8277
Email address
rghorbani.kh98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Eight Weeks of Intradialytic Combined Resistance and Aerobic Exercise on Quality of Life and Related Factors in Hemodialysis Children.
Public title
Investigating the Effect of Intradialytic Exercise in Children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum two months of hemodialysis history
No history of ischemic heart disease or pulmonary diseases
No musculoskeletal disorders that would prevent exercise
Children aged 8 to 18 years with a stable disease condition
At least two hemodialysis sessions per week
Exclusion criteria:
Inability to perform exercise
Shortness of breath during exercise
Any heart or lung disease
Age
From 8 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
8
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Sport Sciences and Health, University of Tehran
Street address
Jalal Al-e Ahmad intersection., Northern Karger Street
City
Tehran
Province
Tehran
Postal code
1439813117
Approval date
2024-08-11, 1403/05/21
Ethics committee reference number
IR.UT.SPORT.REC.1403.058
Health conditions studied
1
Description of health condition studied
Chronic Kidney Disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Quality Of Life
Timepoint
Before the start of the first training session and after eight weeks at the end of the 24th session
Method of measurement
PedsQL questionnaire
Secondary outcomes
1
Description
Dialysis Adequacy
Timepoint
Before the start of the first training session and after eight weeks at the end of the 24th session
Method of measurement
Dialysis Adequacy Formula
2
Description
Blood Electrolytes
Timepoint
Before the start of the first training session and after eight weeks at the end of the 24th session
Method of measurement
Blood Test
Intervention groups
1
Description
Intervention group: Investigating the effect of exercise, including resistance training for the upper body using weights and aerobic training for the lower body using pedals.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Children's hospital
Full name of responsible person
Masoumeh Mohkam
Street address
Shariati Street
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2290 4603
Email
mofidlib@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Tehran
Full name of responsible person
Mohammadreza Kordi
Street address
Jalal Al-e Ahmad intersection., Northern Karger Street
City
Tehran
Province
Tehran
Postal code
1439813117
Phone
+98 21 8835 1730
Email
infosport@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Reza Ghorbani khosroshahi
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Exersie Physiology
Street address
Jalal Al-e Ahmad intersection., Northern Karger Street
City
Tehran
Province
Tehran
Postal code
1541755493
Phone
+98 21 8835 1730
Email
rghorbani.kh98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of tehran
Full name of responsible person
Reza Ghorbani khosroshahi
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Jalal Al-e Ahmad intersection., Northern Karger Street
City
Tehran
Province
Tehran
Postal code
1541755493
Phone
+98 21 8835 1730
Email
rghorbani.kh98@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Reza Ghorbani khosroshahi
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Jalal Al-e Ahmad intersection., Northern Karger Street
City
Tehran
Province
Tehran
Postal code
1541755493
Phone
+98 21 8835 1730
Email
Rghorbani.kh98@gmail.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