The goal of this clinical trial is to investigate the effects of a-12-week virtual reality exercise program, applied as tele-exercise, on the exercise capacity of children with cystic fibrosis, whose physical activity level is further restricted during the pandemic. The main questions it aims to answer are: Does aerobic tele-exercise increase functional capacity in cystic fibrosis patients? Will there be a difference in treatment outcomes between the virtual reality group and the online exercise group? Participants will be randomized into two groups; virtual reality group and online group. Physical activity will be provided to the virtual reality group in the form of team activities in a virtual environment, and the other group will be provided online exercises at their home. For this purpose, virtual reality headsets will be provided to patients to give the impression of a natural, immersive environment and realistic experience. Researchers will compare exercise compliance and functional capacity between the virtual reality group and the online group.
This project aims to investigate the effects of a-12-week virtual reality exercise program, applied as tele-exercise, on the exercise capacity of children with cystic fibrosis, whose physical activity level is further restricted during the pandemic. The originality of this study is that it would be the first study in which immersive virtual reality exercises will be performed through tele-exercise in cystic fibrosis. Prognosis in cystic fibrosis is related to respiratory capacity and physical activity level. Aerobic exercise positively affects lung functions; increases aerobic capacity, survival and quality of life in cystic fibrosis. Face-to-face activities in children with cystic fibrosis increase the risk of cross-contamination and lung infection. Remote exercises will be more cost effective in terms of transportation/time loss as well as reduction of infection risk. Virtual reality exercises based on video game activities provide a good alternative, especially for motivating and increasing the adaptation of young individuals to rehabilitation. This project plans to investigate the hypothesis that exercise capacities would increase with virtual reality exercises performed in groups that help socialization, without the risk of hospital infection. Patients will be randomized into two groups. Physical activity will be provided to the virtual reality group in the form of team activities in a virtual environment. For this purpose, virtual reality headsets will be provided to patients to give the impression of a natural, immersive environment and realistic experience. The activities will be carried out in groups of 4-6 children with cystic fibrosis, accompanied by a physiotherapist, for 12 weeks, 3 days a week, between 30-45 minutes in both groups. At the beginning and end of the 12-week program, patients will be evaluated. The 6-minute walk test will be used to measure exercise capacity in children with cystic fibrosis. At the end of the treatment, it is expected that children with cystic fibrosis in the virtual reality group will reach as high exercise capacity as the other group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
Virtual reality is a simulated experience that creates a virtual environment to give the user the feeling of an immersive virtual world, using glasses and a handheld device that can track hand movements. Activities that will improve the functional and respiratory capacity of children with cystic fibrosis will be developed and integrated into the virtual reality game.
Online exercises are physical activities that are performed via a video-conferencing tool. Children will be at their home environment and exercises which will improve their functional and respiratory capacity will be instructed and supervised by a physiotherapist.
Koc University School of Medicine
Istanbul, Turkey (Türkiye)
6-minute walk distance
6-minute walk distance is a valid and reproducible test in the assessment of functional capacity in children and adolescent with cystic fibrosis. The children were asked to walk in a 30-meter corridor as far as possible in 6 minutes. Distance covered in 6 minutes was recorded as the primary outcome measure.
Time frame: 12 weeks
Hand grip strength
Hand grip strength is an indicator of overall muscle strength and will be measured using a dynamometer. Maximum of the six trials and the dominance of hand with the maximum measurement will be recorded in kg.
Time frame: 12 weeks
Quadriceps strength
Quadriceps strength will be measured using the digital dynamometer. Strength will be measured in both limbs.
Time frame: 12 weeks
Deltoid strength
Deltoid strength will be measured using the digital dynamometer. Strength will be measured in both limbs.
Time frame: 12 weeks
Cystic Fibrosis Questionnaire-Revised
Health-related quality of life was assessed using Cystic Fibrosis Questionnaire-Revised. Items are scored using a 4-point Likert scale. Total score ranges between 0 to 100. Higher scores indicate better quality of life. The questionnaire operates under 9 quality of health domains (physical functioning, role functioning, vitality, emotional functioning, social functioning, body image, eating problems, treatment burden and school functioning), 1 health perception (health perception) and 3 symptom domains (weight, respiratory and digestive symptoms).
Time frame: 12 weeks
Forced expiratory volume
Pulmonary function test will be assessed using a spirometry according to the guideline of American Thoracic Society. Forced expiratory volume in 1 second will be recorded.
Time frame: 12 weeks
Forced vital capacity
Pulmonary function test will be assessed using a spirometry according to the guideline of American Thoracic Society. Forced vital capacity will be recorded
Time frame: 12 weeks
Forced expiratory volume/Forced vital capacity
Pulmonary function test will be assessed using a spirometry according to the guideline of American Thoracic Society. Forced expiratory volume/Forced vital capacity will be recorded
Time frame: 12 weeks
The Physical Activity Questionnaire
To assess the level of physical activity in children, The Physical Activity Questionnaire for Older Children and adolescents will be used, which consist of 10 and 9 items, respectively. First item asks frequency of participation in 14 and 22 common leisure and sport activities in the past 7 days, respectively. Each item is scored on a 5-point rating scale and a mean score for the first item is calculated. Total score is the mean of scores of all items (1: low level of physical activity and 5: high level of physical activity)
Time frame: 12 weeks
System Usability Scale
To evaluate the virtual reality or online exercise experience Turkish translation of the System Usability Scale will be applied.
Time frame: up to 12 weeks
The Physical Activity Enjoyment Scale
The Physical Activity Enjoyment Scale- short scale consists of 8 items. It will be used to assess the pleasure from physical activity. Each item is scored rated on a 7-point Likert-type scale (1: strongly disagree to 7: strongly agree).
Time frame: up to 12 weeks
Accelerometer
All participants will be asked to wear Actiwatch-2 wrist accelerometer to measure activity. It records and stores the time and the intensity of movements. Actiwatch data will be transferred offline to a computer and automatically stored in activity counts by date and time using a software. Participants will wear the actiwatch continuously on the wrist of their non-dominant hand, removing the device only for activities involving water..
Time frame: 12 weeks
Body weight
Body weight will be measured as kilograms with Bioimpedance analysis.
Time frame: 12 weeks
Body height
Body height will be measured as meters with Bioimpedance analysis.
Time frame: 12 weeks
Body mass index
Body mass index z score will be calculated by adjusting weight and height values measured according to age and gender of the children as kg/m\^2.
Time frame: 12 weeks
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