Cystic Fibrosis in ChildrenNCT05850351
Virtual Reality Based Tele-Exercises on Exercise Capacity in Cystic Fibrosis
A study testing Virtual reality and Online in people with Cystic Fibrosis in Children and Telerehabilitation, run by Koç University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Cystic Fibrosis in Children, Telerehabilitation, Virtual Reality
- What is being tested?
- Virtual reality and Online
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Koc University School of Medicine
Istanbul, 34010
About this study
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
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?
Read more
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.
Read the 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.
- Being tested
- Virtual reality, Online
- Keywords
- Cystic Fibrosis, Aerobic Exercise, Telerehabilitation, Virtual Reality
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
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.
OnlineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Online |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (14)
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.
Measured: 12 weeks
Quadriceps strength
Quadriceps strength will be measured using the digital dynamometer. Strength will be measured in both limbs.
Measured: 12 weeks
Deltoid strength
Deltoid strength will be measured using the digital dynamometer. Strength will be measured in both limbs.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 12 weeks
System Usability Scale
To evaluate the virtual reality or online exercise experience Turkish translation of the System Usability Scale will be applied.
Measured: 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).
Measured: 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..
Measured: 12 weeks
Body weight
Body weight will be measured as kilograms with Bioimpedance analysis.
Measured: 12 weeks
Body height
Body height will be measured as meters with Bioimpedance analysis.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start30 May 2023
- Primary completion30 Mar 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Ozden Ozyemisci Taskiran, Koç University
- Investigators
- Ozden Ozyemisci Taskiran, Prof, Principal investigator, Prof
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850351
- Sponsor's protocol ID
- 2022.153.IRB1.056
- Status last verified
- Mar 2025
- First submitted
- 17 Apr 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29605218Holland 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.
PubMed 25359355Bhatia 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.
PubMed 30761692Hommerding 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.
PubMed 20507656Bellini 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.
PubMed 33745579Roberts 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.
PubMed 21624928Bohannon 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.
PubMed 28350764Bobos 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.
PubMed 31730754Villafane 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.
PubMed 25557054Sole 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.
PubMed 29157922Quittner 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.
PubMed 21993695Crocker 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.
PubMed 9346166Erdim 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.
PubMed 30764593Mullen 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.
PubMed 21951520Ozyemisci 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.
PubMed 40983137
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05850351
- Acronym / sponsor ID
- 2022.153.IRB1.056
- Keywords
- Cystic Fibrosis, Aerobic Exercise, Telerehabilitation, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Other: Virtual realityChildren 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. |
| Online | Experimental | Other: OnlineChildren 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. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityVirtual 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. | Other | Virtual reality |
| OnlineOnline 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. | Other | Online |
Primary outcome
6-minute walk distance
Time frame: 12 weeks
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.
14 secondary outcomes
Hand grip strength
Time frame: 12 weeks
Quadriceps strength
Time frame: 12 weeks
Deltoid strength
Time frame: 12 weeks
Cystic Fibrosis Questionnaire-Revised
Time frame: 12 weeks
Forced expiratory volume
Time frame: 12 weeks
Forced vital capacity
Time frame: 12 weeks
Forced expiratory volume/Forced vital capacity
Time frame: 12 weeks
The Physical Activity Questionnaire
Time frame: 12 weeks
System Usability Scale
Time frame: up to 12 weeks
The Physical Activity Enjoyment Scale
Time frame: up to 12 weeks
Accelerometer
Time frame: 12 weeks
Body weight
Time frame: 12 weeks
Body height
Time frame: 12 weeks
Body mass index
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Background: PubMed 29605218Andrade 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.
- Background: PubMed 25359355Holland 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.
- Background: PubMed 30761692Bhatia 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.
- Background: PubMed 20507656Hommerding 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.
- Background: PubMed 33745579Bellini 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.
- Background: PubMed 21624928Roberts 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.
- Background: PubMed 28350764Bohannon 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.
- Background: PubMed 31730754Bobos 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.
- Background: PubMed 25557054Villafane 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.
- Background: PubMed 29157922Sole 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.
- Background: PubMed 21993695Quittner 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.
- Background: PubMed 9346166Crocker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozden Ozyemisci Taskiran, Prof principal investigator
Prof
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality and Online in people with Cystic Fibrosis in Children and Telerehabilitation, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk distance (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05850351, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.