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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04038892
Other study ID # bvuhucgun01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 27, 2019
Est. completion date February 6, 2021

Study information

Verified date February 2021
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date February 6, 2021
Est. primary completion date February 6, 2021
Accepts healthy volunteers No
Gender All
Age group 8 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.).
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).

Locations

Country Name City State
Turkey Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Respiratory Function Test Change from baseline Forced Vital Capacity (FVC) at 8 weeks Eight weeks
Primary Respiratory Function Test Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks Eight weeks
Primary Respiratory Function Test Change from baseline Peak Expiratory Flow (PEF) at 8 weeks Eight weeks
Primary Respiratory Muscle Strength Change from baseline maximum inspiratory pressure (MIP) at 8 weeks Eight weeks
Primary Respiratory Muscle Strength Change from baseline maximum expiratory pressure (MEP) at 8 weeks Eight weeks
Primary Functional Capacity Change from baseline distance covered in six-minute walk test at 8 weeks Eight weeks
Primary Balance Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks Eight weeks
Primary Balance Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks Eight weeks
Primary Balance Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks Eight weeks
Primary Peripheral Muscle Strength Change from baseline M. Quadriceps strength at 8 weeks Eight weeks
Primary Peripheral Muscle Strength Change from baseline M. Biceps strength at 8 weeks Eight weeks
Primary Peripheral Muscle Strength Change from baseline handgrip strength at 8 weeks Eight weeks
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