- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04038892
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
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34060
- Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Bronchiectasis diagnosis
- Stable clinical condition (no exacerbation in last 4 weeks)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: Control Group
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.
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Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage, coughing techniques and teaching respiratory control.
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EXPERIMENTAL: Nintendo Wii Fit Training Group
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.
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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 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.).
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EXPERIMENTAL: BreathingLabs Breathing Games Training Group
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.
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Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage, coughing techniques and teaching respiratory control.
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory Function Test
Time Frame: Eight weeks
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Change from baseline Forced Vital Capacity (FVC) at 8 weeks
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Eight weeks
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Respiratory Function Test
Time Frame: Eight weeks
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Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
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Eight weeks
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Respiratory Function Test
Time Frame: Eight weeks
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Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
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Eight weeks
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Respiratory Muscle Strength
Time Frame: Eight weeks
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Change from baseline maximum inspiratory pressure (MIP) at 8 weeks
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Eight weeks
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Respiratory Muscle Strength
Time Frame: Eight weeks
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Change from baseline maximum expiratory pressure (MEP) at 8 weeks
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Eight weeks
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Functional Capacity
Time Frame: Eight weeks
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Change from baseline distance covered in six-minute walk test at 8 weeks
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Eight weeks
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Balance
Time Frame: Eight weeks
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Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
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Eight weeks
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Balance
Time Frame: Eight weeks
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Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
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Eight weeks
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Balance
Time Frame: Eight weeks
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Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks
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Eight weeks
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Peripheral Muscle Strength
Time Frame: Eight weeks
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Change from baseline M. Quadriceps strength at 8 weeks
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Eight weeks
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Peripheral Muscle Strength
Time Frame: Eight weeks
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Change from baseline M. Biceps strength at 8 weeks
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Eight weeks
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Peripheral Muscle Strength
Time Frame: Eight weeks
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Change from baseline handgrip strength at 8 weeks
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Eight weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- bvuhucgun01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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