Virtual Reality Based Tele-Exercises on Exercise Capacity in Cystic Fibrosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of 12-Week-Virtual Reality Based Tele-Exercises on Exercise Capacity in Cystic Fibrosis Patients: A Randomized Controlled, Single (Assessor)-Blind Study

Conditions
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Cystic Fibrosis in Children, Telerehabilitation, Virtual Reality

Intervention / Treatment
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* Other: Virtual reality
* Other: Online


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 12 and 16 years, Clinical stability without disease exacerbations in the 4 weeks prior to their enrollment into the study Having access to internet and parental or legal caregiver consent Exclusion Criteria: Children with a pulmonary exacerbation in the previous 4 weeks, Active pulmonary infection, Evidence of pulmonary hypertension Any cardiological, musculoskeletal, neurological or cognitive comorbidities that prevent exercise participation, Behavioral ot intellectual difficulties that prevent participation in assessments or exercises provided remotely Children with oxygen supplementation (daily continuous use or > 2 L/min at night) Lung transplant candidates

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality<br>Children with cystic fibrosis will be given exercise in the form of a game in a virtual environment in groups of 4-6 children, accompanied by a physiotherapist, for 12 weeks, 3 days a week, between 30-45 minutes. | Other: Virtual reality<br>* 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.<br>|
| Experimental: Online<br>Children with cystic fibrosis will be given online aerobic exercise for 12 weeks, 3 days a week, 30-45 minutes, in groups of 4-6 children, accompanied by a physiotherapist. | Other: Online<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| Quadriceps strength | Quadriceps strength will be measured using the digital dynamometer. Strength will be measured in both limbs. | 12 weeks | 
| Deltoid strength | Deltoid strength will be measured using the digital dynamometer. Strength will be measured in both limbs. | 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). | 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. | 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 | 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 | 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) | 12 weeks | 
| System Usability Scale | To evaluate the virtual reality or online exercise experience Turkish translation of the System Usability Scale will be applied. | 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). | 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.. | 12 weeks | 
| Body weight | Body weight will be measured as kilograms with Bioimpedance analysis. | 12 weeks | 
| Body height | Body height will be measured as meters with Bioimpedance analysis. | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis, Aerobic Exercise, Telerehabilitation, Virtual Reality