Investigation the effect of physical rehabilitation program’s implementation on the physical performance and quality of life rate on hospitalized children undergoing congenital heart disease surgery in intensive care units of chamran hospital in 2019
Investigation the effect of physical rehabilitation program’s implementation on the physical performance and quality of life rate on hospitalized children undergoing congenital heart disease surgery in intensive care units
Design
The study is a two-stage clinical trial with two groups. For this purpose, 60 children undergo cardiac surgery. The sampling method will be easy to divide into two groups of intervention and control.
Settings and conduct
The research environment of the pediatric intensive care unit of Shahid Chamran Hospital is affiliated to Isfahan University of Medical Sciences and is followed by a pediatric and then a baby home.In order to carry out research, the researcher will refer to Shahid Chamran Hospital in Isfahan University of medical sciences in order to carry out the research. After describing the objectives and the research process, the collaboration between the hospital and the competent authorities of the pediatric and intensive care units will be sought.
Participants/Inclusion and exclusion criteria
Age range between three and seven years-- Not accompanied by congenital anomaly of the heart with other physical disorders-
Exit conditions:The existence of life-threatening arrhythmias-Failure of the physician to continue the rehab program
Intervention groups
Use a routine program for the control group and use a rehab protocol for the intervention group
Main outcome variables
Physical performance , Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190129042547N1
Registration date:2019-04-04, 1398/01/15
Registration timing:prospective
Last update:2019-04-04, 1398/01/15
Update count:0
Registration date
2019-04-04, 1398/01/15
Registrant information
Name
asghar jamshidian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3264 1887
Email address
jamshidian@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of physical rehabilitation program’s implementation on the physical performance and quality of life rate on hospitalized children undergoing congenital heart disease surgery in intensive care units of chamran hospital in 2019
Public title
Investigation the effect of physical rehabilitation program’s implementation on the physical performance and quality of life on Children undergoing cardiac surgery.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
- The research unit has no psychiatric disorders or limiting movements
- have age limits of between three years of age
- The doctor will allow the child to attend the rehab program
- Not accompanied by congenital anomaly of the heart with other physical disorders
- Failure to implement previous rehab programs on the research unit
Research units or parents who would like to participate in this research project
- His vital signs are within his normal range
- During the procedure, only the parents will take care of the child before surgery until one month later
- Their place of residence is Isfahan city and the area where the researcher is able to meet their personal presence.
- Ability to make phone calls and stay in touch with the family
Children aged 3 to 7 years with congenital heart defects
Exclusion criteria:
Child's death during study
- Family unwillingness to continue active participation in the research
The presence of threatening arrhythmias
- Failure in renal function or other organs of the body
Failure of the physician to continue the rehab program
Age
From 3 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment is used in two groups of random numbers.Using this table, by closing the eyes and by placing a finger on one of the numbers, that number will be selected.The direction to move is predefined and horizontally to the right, then to the top and then to the left of the table.Each number will be placed in group A or intervention, and each pair number will be entered in group B or control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The research area of the pediatric intensive care unit of Martyr Dr. Chamran Hospital
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice- chancellor in research affairs -medical univercity of isfahan
Street address
Deputy of Research and Technology of the University,Building No. 4,Isfahan University Of Medical Sciences,Heza jerib Ave
City
isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2019-02-27, 1397/12/08
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.467
Health conditions studied
1
Description of health condition studied
congenital heart disease
ICD-10 code
Q24.9
ICD-10 code description
Congenital malformation of heart, unspecified
Primary outcomes
1
Description
Physical performance
Timepoint
Before the intervention and one month after the discharge from the hospital
Method of measurement
Early Years Physical Activity Questionaire
2
Description
Quality of life
Timepoint
Before the intervention and one month after the discharge from the hospital
Method of measurement
Paediatric Quality of Life Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use of three rehab techniques after the presence of a child in the intensive care unit following cardiac surgery: 1- Kinesitherapy(KTH) 2-Respiratory Physical Therapy 3-Sitting Balance Exercise:This part of the movements, day-after-surgery moves will begin with a balanced baby's condition, which will be held once a day, at least three times a day, and each time it lasts for 20 to 60 minutes.----Program designed for home activity:Postural training-Flexibility training-Breathing training-Muscle strength training-Developmental activities-Aerobic endurance training:These movements will be started in a month and on a daily basis from the time the child is admitted to the pediatric ward and will continue at home.Each session of the program includes 5 to 10 minutes of warm-up, 30 minutes of aerobic exercise, with a low to moderate intensity and 5 minutes of cooling down.
Category
Rehabilitation
2
Description
Control group: For the control group, the routine of the child care and care units and the protocol that the hospital has implemented so far will be used, including providing family descriptions of physical rehab programs in verbal conversation and answering their questions in this regard And offering educational pamphlets.For the investigated families, a classroom session is organized individually and grouply, at the beginning of the course.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Jamshidian Asghar
Street address
Chamran hospital,Moshtagh 3 Ave
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Fax
+98 31 3261 1405
Email
jamshidian@nm.mui.ac.ir
Web page address
http://chamran.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Haghjooe Javanmard Shaghaiegh
Street address
Deputy of Research and Technology of the University,Building No. 4,Isfahan University Of Medical Sciences,Heza jerib Ave
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 5149
Email
jamshidian@nm.mui.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
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Khalifezadeh Asghar
Position
Academic Member In Isfahan University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 4,40 Alley,Dashtestan Ave
City
Isfahan
Province
Isfehan
Postal code
73461- 81746
Phone
+98 31 3792 7511
Email
khalifezadeh@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Khalifehzadeh Asghar
Position
Academic Member In Isfahan University of Medical Sciences