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

December 1, 2025 updated by: Ozden Ozyemisci Taskiran, Koç University

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?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34010
        • Koç University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Experimental: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand grip strength
Time Frame: 12 weeks
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
Time Frame: 12 weeks
Quadriceps strength will be measured using the digital dynamometer. Strength will be measured in both limbs.
12 weeks
Deltoid strength
Time Frame: 12 weeks
Deltoid strength will be measured using the digital dynamometer. Strength will be measured in both limbs.
12 weeks
Cystic Fibrosis Questionnaire-Revised
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: up to 12 weeks
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
Time Frame: up to 12 weeks
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
Time Frame: 12 weeks

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
Time Frame: 12 weeks
Body weight will be measured as kilograms with Bioimpedance analysis.
12 weeks
Body height
Time Frame: 12 weeks
Body height will be measured as meters with Bioimpedance analysis.
12 weeks
Body mass index
Time Frame: 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koç University

Collaborators

The Scientific and Technological Research Council of Turkey

Investigators

  • Principal Investigator: Ozden Ozyemisci Taskiran, Prof, Prof

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2023

Primary Completion (Actual)

March 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

April 17, 2023

First Submitted That Met QC Criteria

April 28, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022.153.IRB1.056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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