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

NCT05850351 | Completed

• 1 other identifier: 2022.153.IRB1.056
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis in Children; Telerehabilitation; Virtual Reality

Keywords

Cystic Fibrosis; Aerobic Exercise; Telerehabilitation; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Hand grip strength

  12 weeks

• Quadriceps strength

  12 weeks

• Deltoid strength

  12 weeks

• Cystic Fibrosis Questionnaire-Revised

  12 weeks

• Forced expiratory volume

  12 weeks

Study Arms (2)

Virtual reality

EXPERIMENTAL

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

Online

EXPERIMENTAL

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

Interventions

Virtual reality OTHER

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.

Virtual reality

Online OTHER

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.

Online

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koç University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Koc University School of Medicine

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (15)

• 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.

  PMID: 29605218 BACKGROUND

• 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.

  PMID: 25359355 BACKGROUND

• 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.

  PMID: 30761692 BACKGROUND

• 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.

  PMID: 20507656 BACKGROUND

• 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.

  PMID: 33745579 BACKGROUND

• 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.

  PMID: 21624928 BACKGROUND

• 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.

  PMID: 28350764 BACKGROUND

• 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.

  PMID: 31730754 BACKGROUND

• 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.

  PMID: 25557054 BACKGROUND

• 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.

  PMID: 29157922 BACKGROUND

• 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.

  PMID: 21993695 BACKGROUND

• 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.

  PMID: 9346166 BACKGROUND

• 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.

  PMID: 30764593 BACKGROUND

• 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.

  PMID: 21951520 BACKGROUND

• 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.

  PMID: 40983137 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Pharmaceutical Services, Online

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ozden Ozyemisci Taskiran, Prof

  Prof

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In the study, outcomes assessor will not know which group the children belong to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 9, 2023
• Study Start: May 30, 2023
• Primary Completion: March 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)