BronchiectasisNCT04038892
The Effect of Different Virtual Reality-Based Exercise Trainings on Pulmonary Function, Respiratory and Peripheral Muscle Strength, Functional Capacity and Balance in Children With Bronchiectasis
A study testing Conventional Chest Physiotherapy, Nintendo Wii Fit Based Exercise Training and BreathingLabs Breathing Games Based Exercise Training in people with Bronchiectasis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Bronchiectasis is defined as abnormal, chronic and permanent enlargement of one or more bronchi. Disease symptoms; often productive cough, dyspnea, fatigue and wheezing. Changing pulmonary mechanics, inadequate gas exchange, decreased muscle mass and associated psychological problems may cause dyspnea, decreased… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Conventional Chest Physiotherapy, Nintendo Wii Fit Based Exercise Training and BreathingLabs Breathing Games Based Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jul 2019to 6 Feb 2021
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Bronchiectasis diagnosis
- Stable clinical condition (no exacerbation in last 4 weeks)
Who cannot join
- Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility
- Subjects previously involved in exercise training or physiotherapy programs
- Previous history of lung or liver transplantation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation
Istanbul, 34060
About this study
Bronchiectasis is defined as abnormal, chronic and permanent enlargement of one or more bronchi. Disease symptoms; often productive cough, dyspnea, fatigue and wheezing. Changing pulmonary mechanics, inadequate gas exchange, decreased muscle mass and associated psychological problems may cause dyspnea, decreased exercise capacity and health-related quality of life. Exercise training as a part of pulmonary rehabilitation is used to reduce the severity of symptoms; is an effective treatment to improve exercise capacity and health status. Virtual reality based exercise training has taken its place in many areas of rehabilitation as a current and new approach. In the studies in the literature, Nintendo Wii Fit games are an effective, motivating, entertaining and clinically useful method for reducing symptoms in the rehabilitation of chronic lung diseases. Wii Fit games generally include strengthening, aerobics and balance exercises. Developed by BreathingLabs, Breathing Games, which is based on breathing exercises, are a new product, a virtual reality application that has been included in a limited number of studies, has shown its effect on reducing respiratory problems and is open to research effects for many patient groups. The importance of this study is that it will be the first study on Nintendo Wii Fit games based exercise training and Breathing Games based breathing exercises training in children with bronchiectasis.
The aim of this study is to investigate the effect of different virtual reality-based exercise trainings on pulmonary function, respiratory and peripheral muscle strength, functional capacity and balance in children with bronchiectasis.
- Conditions
- Bronchiectasis
- Being tested
- Conventional Chest Physiotherapy, Nintendo Wii Fit Based Exercise Training, BreathingLabs Breathing Games Based Exercise Training
- Keywords
- Bronchiectasis, Virtual Reality, Exercise Training, Pulmonary Function, Functional Capacity, 6 Minute Walk Test, Balance, Muscle Strength
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Chest PhysiotherapyOther
Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage, coughing techniques and teaching respiratory control.
Nintendo Wii Fit Based Exercise TrainingOther
Nintendo Wii Fit based exercise training will be given under the supervision of a physiotherapist. The one session will be included: warm-up exercises for 5 minutes (yoga games; deep breathing and half moon etc.), aerobic exercises for 30 minutes (aerobic games; Twisting and Squat, Step Plus, Jogging Plus and Hula Hoop etc.) and cooling exercises in 5 minutes (yoga games; deep breathing and half moon etc.).
BreathingLabs Breathing Games Based Exercise TrainingOther
BreathingLabs Breathing Games based exercise training will be given under the supervision of a physiotherapist. The one session will be included: warm-up exercises for 5 minutes (respiratory control exerice and coughing techniques), breathing games exercises for 30 minutes (breathing games; Kite, Balloon, Pluto, Butterflies and Plane etc.) and cooling exercises in 5 minutes (respiratory control exerice and coughing techniques).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients in this group will receive conventional chest physiotherapy, two times a day, 7 days a week for 8 weeks. After the training given by the physiotherapist, all exercise sessions will be performed at home. Receives: Other: Conventional Chest Physiotherapy |
| Nintendo Wii Fit Training Group | Experimental | In addition to conventional chest physiotherapy programme, patients in this group will also receive Nintendo Wii Fit based exercise training for 40 minutes, 2 times in a week for 8 weeks. All exercise sessions will be supervised by physiotherapist in a clinic per week. Receives: Other: Conventional Chest Physiotherapy; Other: Nintendo Wii Fit Based Exercise Training |
| BreathingLabs Breathing Games Training Group | Experimental | In addition to conventional chest physiotherapy programme, patients in this group will also receive BreathingLabs Breathing Games based exercise training for 40 minutes, 2 times in a week for 8 weeks. All exercise sessions will be supervised by physiotherapist in a clinic per week. Receives: Other: Conventional Chest Physiotherapy; Other: BreathingLabs Breathing Games Based Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Function Test
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Measured: Eight weeks
Respiratory Function Test
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Measured: Eight weeks
Respiratory Function Test
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Measured: Eight weeks
Respiratory Muscle Strength
Change from baseline maximum inspiratory pressure (MIP) at 8 weeks
Measured: Eight weeks
Respiratory Muscle Strength
Change from baseline maximum expiratory pressure (MEP) at 8 weeks
Measured: Eight weeks
Functional Capacity
Change from baseline distance covered in six-minute walk test at 8 weeks
Measured: Eight weeks
Balance
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
Measured: Eight weeks
Balance
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Measured: Eight weeks
Balance
Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks
Measured: Eight weeks
Peripheral Muscle Strength
Change from baseline M. Quadriceps strength at 8 weeks
Measured: Eight weeks
Peripheral Muscle Strength
Change from baseline M. Biceps strength at 8 weeks
Measured: Eight weeks
Peripheral Muscle Strength
Change from baseline handgrip strength at 8 weeks
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start27 Jul 2019
- Primary completion6 Feb 2021
- Study completion6 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hikmet Uçgun, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038892
- Sponsor's protocol ID
- bvuhucgun01
- Status last verified
- Feb 2021
- First submitted
- 27 Jul 2019
- Last updated
- 9 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Virtual Reality-Based Exercise Trainings on Pulmonary Function, Respiratory and Peripheral Muscle Strength, Functional Capacity and Balance in Children With Bronchiectasis
- ClinicalTrials.gov ID
- NCT04038892
- Acronym / sponsor ID
- bvuhucgun01
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, Virtual Reality, Exercise Training, Pulmonary Function, Functional Capacity, 6 Minute Walk Test, Balance, Muscle Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 27 Jul 2019 (actual)
- Primary completion
- 6 Feb 2021 (actual)
- Study completion
- 6 Feb 2021 (actual)
- First posted
- 31 Jul 2019 (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.
Bronchiectasis is defined as abnormal, chronic and permanent enlargement of one or more bronchi. Disease symptoms; often productive cough, dyspnea, fatigue and wheezing. Changing pulmonary mechanics, inadequate gas exchange, decreased muscle mass and associated psychological problems may cause dyspnea, decreased exercise capacity and health-related quality of life. Exercise training as a part of pulmonary rehabilitation is used to reduce the severity of symptoms; is an effective treatment to improve exercise capacity and health status. Virtual reality based exercise training has taken its place in many areas of rehabilitation as a current and new approach. In the studies in the literature, Nintendo Wii Fit games are an effective, motivating, entertaining and clinically useful method for reducing symptoms in the rehabilitation of chronic lung diseases. Wii Fit games generally include strengthening, aerobics and balance exercises. Developed by BreathingLabs, Breathing Games, which is based on breathing exercises, are a new product, a virtual reality application that has been included in a limited number of studies, has shown its effect on reducing respiratory problems and is open to research effects for many patient groups. The importance of this study is that it will be the first study on Nintendo Wii Fit games based exercise training and Breathing Games based breathing exercises training in children with bronchiectasis.
The aim of this study is to investigate the effect of different virtual reality-based exercise trainings on pulmonary function, respiratory and peripheral muscle strength, functional capacity and balance in children with bronchiectasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Conventional Chest PhysiotherapyPatients in this group will receive conventional chest physiotherapy, two times a day, 7 days a week for 8 weeks. After the training given by the physiotherapist, all exercise sessions will be performed at home. |
| Nintendo Wii Fit Training Group | Experimental | Other: Conventional Chest Physiotherapy, Other: Nintendo Wii Fit Based Exercise TrainingIn addition to conventional chest physiotherapy programme, patients in this group will also receive Nintendo Wii Fit based exercise training for 40 minutes, 2 times in a week for 8 weeks. All exercise sessions will be supervised by physiotherapist in a clinic per week. |
| BreathingLabs Breathing Games Training Group | Experimental | Other: Conventional Chest Physiotherapy, Other: BreathingLabs Breathing Games Based Exercise TrainingIn addition to conventional chest physiotherapy programme, patients in this group will also receive BreathingLabs Breathing Games based exercise training for 40 minutes, 2 times in a week for 8 weeks. All exercise sessions will be supervised by physiotherapist in a clinic per week. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Bronchiectasis diagnosis
- Stable clinical condition (no exacerbation in last 4 weeks)
Key exclusion criteria (3 listed)
- Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility
- Subjects previously involved in exercise training or physiotherapy programs
- Previous history of lung or liver transplantation
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 |
|---|---|---|
| Conventional Chest PhysiotherapyProgramme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage, coughing techniques and teaching respiratory control. | Other | BreathingLabs Breathing Games Training Group, Control Group, Nintendo Wii Fit Training Group |
| Nintendo Wii Fit Based Exercise TrainingNintendo Wii Fit based exercise training will be given under the supervision of a physiotherapist. The one session will be included: warm-up exercises for 5 minutes (yoga games; deep breathing and half moon etc.), aerobic exercises for 30 minutes (aerobic games; Twisting and Squat, Step Plus, Jogging Plus and Hula Hoop etc.) and cooling exercises in 5 minutes (yoga games; deep breathing and half moon etc.). | Other | Nintendo Wii Fit Training Group |
| BreathingLabs Breathing Games Based Exercise TrainingBreathingLabs Breathing Games based exercise training will be given under the supervision of a physiotherapist. The one session will be included: warm-up exercises for 5 minutes (respiratory control exerice and coughing techniques), breathing games exercises for 30 minutes (breathing games; Kite, Balloon, Pluto, Butterflies and Plane etc.) and cooling exercises in 5 minutes (respiratory control exerice and coughing techniques). | Other | BreathingLabs Breathing Games Training Group |
Primary outcome
Respiratory Function Test
Time frame: Eight weeks
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Respiratory Function Test
Time frame: Eight weeks
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Respiratory Function Test
Time frame: Eight weeks
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Respiratory Muscle Strength
Time frame: Eight weeks
Change from baseline maximum inspiratory pressure (MIP) at 8 weeks
Respiratory Muscle Strength
Time frame: Eight weeks
Change from baseline maximum expiratory pressure (MEP) at 8 weeks
Functional Capacity
Time frame: Eight weeks
Change from baseline distance covered in six-minute walk test at 8 weeks
Balance
Time frame: Eight weeks
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
Balance
Time frame: Eight weeks
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Balance
Time frame: Eight weeks
Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks
Peripheral Muscle Strength
Time frame: Eight weeks
Change from baseline M. Quadriceps strength at 8 weeks
Peripheral Muscle Strength
Time frame: Eight weeks
Change from baseline M. Biceps strength at 8 weeks
Peripheral Muscle Strength
Time frame: Eight weeks
Change from baseline handgrip strength at 8 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 9 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Chest Physiotherapy, Nintendo Wii Fit Based Exercise Training and BreathingLabs Breathing Games Based Exercise Training in people with Bronchiectasis, run by Bezmialem Vakif 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 2 inclusion and 3 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 9 Feb 2021. 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?
Respiratory Function Test (time frame: Eight weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2021.