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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

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ClinicalTrials.gov Identifier: NCT04038892
Recruitment Status : Not yet recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Hikmet Uçgun, Bezmialem Vakif University

Brief 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 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.


Condition or disease Intervention/treatment Phase
Bronchiectasis Other: Conventional Chest Physiotherapy Other: Nintendo Wii Fit Based Exercise Training Other: BreathingLabs Breathing Games Based Exercise Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 27, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Conventional Chest Physiotherapy
Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage, coughing techniques and teaching respiratory control.

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.
Other: Conventional Chest Physiotherapy
Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage, coughing techniques and teaching respiratory control.

Other: Nintendo Wii Fit Based Exercise Training
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.).

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.
Other: Conventional Chest Physiotherapy
Programme 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 Based Exercise Training
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).




Primary Outcome Measures :
  1. Respiratory Function Test [ Time Frame: Eight weeks ]
    Change from baseline Forced Vital Capacity (FVC) at 8 weeks

  2. Respiratory Function Test [ Time Frame: Eight weeks ]
    Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks

  3. Respiratory Function Test [ Time Frame: Eight weeks ]
    Change from baseline Peak Expiratory Flow (PEF) at 8 weeks

  4. Respiratory Muscle Strength [ Time Frame: Eight weeks ]
    Change from baseline maximum inspiratory pressure (MIP) at 8 weeks

  5. Respiratory Muscle Strength [ Time Frame: Eight weeks ]
    Change from baseline maximum expiratory pressure (MEP) at 8 weeks

  6. Functional Capacity [ Time Frame: Eight weeks ]
    Change from baseline distance covered in six-minute walk test at 8 weeks

  7. Balance [ Time Frame: Eight weeks ]
    Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks

  8. Balance [ Time Frame: Eight weeks ]
    Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks

  9. Balance [ Time Frame: Eight weeks ]
    Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks

  10. Peripheral Muscle Strength [ Time Frame: Eight weeks ]
    Change from baseline M. Quadriceps strength at 8 weeks

  11. Peripheral Muscle Strength [ Time Frame: Eight weeks ]
    Change from baseline M. Biceps strength at 8 weeks

  12. Peripheral Muscle Strength [ Time Frame: Eight weeks ]
    Change from baseline handgrip strength at 8 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038892


Contacts
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Contact: Hikmet Ucgun, PT, PhD (c) +902125232288 ext 4626 hucgun@bezmialem.edu.tr

Sponsors and Collaborators
Bezmialem Vakif University

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Responsible Party: Hikmet Uçgun, Research Assistant, PT, PhD (c), Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT04038892     History of Changes
Other Study ID Numbers: bvuhucgun01
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hikmet Uçgun, Bezmialem Vakif University:
Bronchiectasis
Virtual Reality
Exercise Training
Pulmonary Function
Functional Capacity
6 Minute Walk Test
Balance
Muscle Strength
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases