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Completed

NCT Number: 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.

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation

Istanbul, 34060, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Chest Physiotherapy

Other

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

Other

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 Training

Other

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 31, 2019
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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