The study has been designed to investigate the effect of 12 weeks of using virtual reality based exercises on pulmonary functions, exercise capacity, functional performance, and quality of life in children with surgically-repaired congenital diaphragmatic hernia.
Children with CDH have significant disruptions in their quality of life (QoL) due to their poor health, in this randomized controlled clinical trial, one important aspect of virtual reality is the interactivity of children and their interests in choosing the exercised game. Each child in two groups perform a specific virtual reality based respiratory exercises for 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
52
resistance-based diaphragm strengthening exercises, breathing exercises to increase costal or chest breathing, and breathing exercises to relax the breathing muscles.
Virtual reality exercise using Nintendo Wii systems. As game interfaces, the Nintendo Wii systems employ haptic sensor-based controllers and a balance board.
Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
Al Kharj, Riyadh Region, Saudi Arabia
Pulmonary function test, forced expiratory volume in the first second
A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan).
Time frame: From date of randomization (first week of intervention)
Pulmonary function test, forced expiratory volume in the first second
A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan).
Time frame: after 12 weeks
Pulmonary function test, forced vital capacity
A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan).
Time frame: From date of randomization (first week of intervention)
Pulmonary function test, forced vital capacity
A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan).
Time frame: after 12 weeks
Pulmonary function test, FEV1/FVC ratio
performed using a spirometer (Autospiro-507; Minato Medical Science; Osaka. Japan)., (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded.
Time frame: From date of randomization (first week of intervention)
Pulmonary function test, FEV1/FVC ratio
performed using a spirometer (Autospiro-507; Minato Medical Science; Osaka. Japan)., (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded.
Time frame: after 12 weeks
Exercise capacity assessment
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Cardiopulmonary pulmonary exercise test using the Bruce treadmill test was used to asess the exercise capacity.
Time frame: From date of randomization (first week of intervention)
Exercise capacity assessment
Cardiopulmonary pulmonary exercise test using the Bruce treadmill test was used to asess the exercise capacity.
Time frame: after 12 weeks
Functional performance assessment
Functional performance was assessed through using the 6-min walk test.
Time frame: From date of randomization (first week of intervention)
Functional performance assessment
Functional performance was assessed through using the 6-min walk test.
Time frame: after 12 weeks
Pediatric Quality of Life Inventory
Quality of life was evaluated using self-report Pediatric Quality of Life Inventory (PedsQL), it is multidimensional measures of HRQL in children and adolescents, it includes 23 items distributed among 4 domains \[physical (8 items) , emotional( 5 items), social ( 5 items ), and school functions ( 3 items )\] including 23 items. It provides child self-report and parents report with 5- points scale ( 0 means never, and 4 means almost always).
Time frame: From date of randomization (first week of intervention)
Pediatric Quality of Life Inventory
Quality of life was evaluated using self-report Pediatric Quality of Life Inventory (PedsQL), it is multidimensional measures of HRQL in children and adolescents, it includes 23 items distributed among 4 domains \[physical (8 items) , emotional( 5 items), social ( 5 items ), and school functions ( 3 items )\] including 23 items. It provides child self-report and parents report with 5- points scale ( 0 means never, and 4 means almost always).
Time frame: after 12 weeks