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 Identifier: NCT04038892
• Recruitment Status: Completed
• First Posted: July 31, 2019
• Last Update Posted: February 9, 2021
• Sponsor: Bezmialem Vakif University
• Information provided by (Responsible Party): Hikmet Uçgun, Bezmialem Vakif University

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39 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
• Actual Study Start Date: July 27, 2019
• Actual Primary Completion Date: February 6, 2021
• Actual Study Completion Date: February 6, 2021

Arms and Interventions

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).

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Turkey

Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation

Istanbul, Turkey, 34060

Sponsors and Collaborators

Bezmialem Vakif University

More Information

• Responsible Party: Hikmet Uçgun, Research Assistant, PT, PhD (c), Bezmialem Vakif University
• ClinicalTrials.gov Identifier: NCT04038892
• Other Study ID Numbers: bvuhucgun01
• First Posted: July 31, 2019
• Last Update Posted: February 9, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Bronchiectasis; Bronchial Diseases; Respiratory Tract Diseases