Virtual Reality Based Tele-Exercises on Exercise Capacity in Cystic Fibrosis
NCT ID: NCT05850351
Last Updated: 2025-12-08
Study Results
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Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2023-05-30
2025-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Virtual reality
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.
Virtual reality
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
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.
Online
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.
Interventions
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Virtual reality
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
16 Years
ALL
No
Sponsors
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The Scientific and Technological Research Council of Turkey
OTHER
Koç University
OTHER
Responsible Party
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Ozden Ozyemisci Taskiran
Clinical Professor
Principal Investigators
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Ozden Ozyemisci Taskiran, Prof
Role: PRINCIPAL_INVESTIGATOR
Prof
Locations
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Koc University School of Medicine
Istanbul, , Turkey (Türkiye)
Countries
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References
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Andrade Lima C, Dornelas de Andrade A, Campos SL, Brandao DC, Mourato IP, Britto MCA. Six-minute walk test as a determinant of the functional capacity of children and adolescents with cystic fibrosis: A systematic review. Respir Med. 2018 Apr;137:83-88. doi: 10.1016/j.rmed.2018.02.016. Epub 2018 Feb 26.
Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
Bhatia R, Kaye M, Roberti-Miller A. Longitudinal assessment of exercise capacity and quality of life outcome measures in cystic fibrosis: A year-long prospective pilot study. J Eval Clin Pract. 2020 Feb;26(1):236-241. doi: 10.1111/jep.13105. Epub 2019 Feb 13.
Hommerding PX, Donadio MV, Paim TF, Marostica PJ. The Borg scale is accurate in children and adolescents older than 9 years with cystic fibrosis. Respir Care. 2010 Jun;55(6):729-33.
Bellini SG, Chapman P, Szendre K, McDonald C, Williams N, Hopkin L, Eggett D, Dean A. Changes in handgrip strength in children with cystic fibrosis compared to children without cystic fibrosis. Clin Nutr ESPEN. 2021 Apr;42:206-211. doi: 10.1016/j.clnesp.2021.01.038. Epub 2021 Feb 9.
Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.
Bohannon RW, Wang YC, Bubela D, Gershon RC. Handgrip Strength: A Population-Based Study of Norms and Age Trajectories for 3- to 17-Year-Olds. Pediatr Phys Ther. 2017 Apr;29(2):118-123. doi: 10.1097/PEP.0000000000000366.
Bobos P, Nazari G, Lu Z, MacDermid JC. Measurement Properties of the Hand Grip Strength Assessment: A Systematic Review With Meta-analysis. Arch Phys Med Rehabil. 2020 Mar;101(3):553-565. doi: 10.1016/j.apmr.2019.10.183. Epub 2019 Nov 13.
Villafane JH, Valdes K, Bertozzi L, Negrini S. Minimal Clinically Important Difference of Grip and Pinch Strength in Women With Thumb Carpometacarpal Osteoarthritis When Compared to Healthy Subjects. Rehabil Nurs. 2017 May/Jun;42(3):139-145. doi: 10.1002/rnj.196.
Sole A, Olveira C, Perez I, Hervas D, Valentine V, Baca Yepez AN, Olveira G, Quittner AL. Development and electronic validation of the revised Cystic Fibrosis Questionnaire (CFQ-R Teen/Adult): New tool for monitoring psychosocial health in CF. J Cyst Fibros. 2018 Sep;17(5):672-679. doi: 10.1016/j.jcf.2017.10.015. Epub 2017 Nov 20.
Quittner AL, Sawicki GS, McMullen A, Rasouliyan L, Pasta DJ, Yegin A, Konstan MW. Psychometric evaluation of the Cystic Fibrosis Questionnaire-Revised in a national sample. Qual Life Res. 2012 Sep;21(7):1267-78. doi: 10.1007/s11136-011-0036-z. Epub 2011 Oct 14.
Crocker PR, Bailey DA, Faulkner RA, Kowalski KC, McGrath R. Measuring general levels of physical activity: preliminary evidence for the Physical Activity Questionnaire for Older Children. Med Sci Sports Exerc. 1997 Oct;29(10):1344-9. doi: 10.1097/00005768-199710000-00011.
Erdim L, Ergun A, Kuguoglu S. Reliability and validity of the Turkish version of the Physical Activity Questionnaire for Older Children (PAQ-C). Turk J Med Sci. 2019 Feb 11;49(1):162-169. doi: 10.3906/sag-1806-212.
Mullen SP, Olson EA, Phillips SM, Szabo AN, Wojcicki TR, Mailey EL, Gothe NP, Fanning JT, Kramer AF, McAuley E. Measuring enjoyment of physical activity in older adults: invariance of the physical activity enjoyment scale (paces) across groups and time. Int J Behav Nutr Phys Act. 2011 Sep 27;8:103. doi: 10.1186/1479-5868-8-103.
Ozyemisci Taskiran O, Albayrak H, Kog C, Atli E, Gonullu E, Yantac AE, Uyan ZS. The effect of a 12-week tele-exercise using immersive virtual reality on functional capacity in adolescents with cystic fibrosis: A randomized controlled, single (assessor) - blind study. Respir Med. 2025 Nov;248:108362. doi: 10.1016/j.rmed.2025.108362. Epub 2025 Sep 20.
Other Identifiers
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2022.153.IRB1.056
Identifier Type: -
Identifier Source: org_study_id
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