Clinical trial NCT05850351: Virtual Reality Based Tele-Exercises on Exercise Capacity in Cystic Fibrosis
Official title: The Effect of 12-Week-Virtual Reality Based Tele-Exercises on Exercise Capacity in Cystic Fibrosis Patients: A Randomized Controlled, Single (Assessor)-Blind Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cystic Fibrosis in Children
Telerehabilitation
Virtual Reality
Keywords: Cystic Fibrosis
Aerobic Exercise
Telerehabilitation
Virtual Reality
Lead sponsor: Koç University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2023-05-09
Enrollment: 36
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 6-minute walk distance
timeFrame: 12 weeks
Secondary outcomes:
measure: Hand grip strength
timeFrame: 12 weeks
measure: Quadriceps strength
timeFrame: 12 weeks
measure: Deltoid strength
timeFrame: 12 weeks
measure: Cystic Fibrosis Questionnaire-Revised
timeFrame: 12 weeks
measure: Forced expiratory volume
timeFrame: 12 weeks
measure: Forced vital capacity
timeFrame: 12 weeks
measure: Forced expiratory volume/Forced vital capacity
timeFrame: 12 weeks
measure: The Physical Activity Questionnaire
timeFrame: 12 weeks
measure: System Usability Scale
timeFrame: up to 12 weeks
measure: The Physical Activity Enjoyment Scale
timeFrame: up to 12 weeks
measure: Accelerometer
timeFrame: 12 weeks
measure: Body weight
timeFrame: 12 weeks
measure: Body height
timeFrame: 12 weeks
measure: Body mass index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University School of Medicine
Study officials:
affiliation: Prof
name: Ozden Ozyemisci Taskiran, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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