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

NCT04038892 | Completed

• 1 other identifier: bvuhucgun01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Keywords

Bronchiectasis; Virtual Reality; Exercise Training; Pulmonary Function; Functional Capacity; 6 Minute Walk Test; Balance; Muscle Strength

Outcome Measures

Primary Outcomes (12)

• Respiratory Function Test

  Change from baseline Forced Vital Capacity (FVC) at 8 weeks

  Eight weeks

• Respiratory Function Test

  Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks

  Eight weeks

• Respiratory Function Test

  Change from baseline Peak Expiratory Flow (PEF) at 8 weeks

  Eight weeks

• Respiratory Muscle Strength

  Change from baseline maximum inspiratory pressure (MIP) at 8 weeks

  Eight weeks

• Respiratory Muscle Strength

  Change from baseline maximum expiratory pressure (MEP) at 8 weeks

  Eight weeks

• Functional Capacity

  Change from baseline distance covered in six-minute walk test at 8 weeks

  Eight weeks

• Balance

  Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks

  Eight weeks

• Balance

  Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks

  Eight weeks

• Balance

  Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks

  Eight weeks

• Peripheral Muscle Strength

  Change from baseline M. Quadriceps strength at 8 weeks

  Eight weeks

• Peripheral Muscle Strength

  Change from baseline M. Biceps strength at 8 weeks

  Eight weeks

• Peripheral Muscle Strength

  Change from baseline handgrip strength at 8 weeks

  Eight weeks

Study Arms (3)

Control Group

ACTIVE COMPARATOR

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

Nintendo Wii Fit Training Group

EXPERIMENTAL

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; Other: Nintendo Wii Fit Based Exercise Training

BreathingLabs Breathing Games Training Group

EXPERIMENTAL

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; Other: BreathingLabs Breathing Games Based Exercise Training

Interventions

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.

BreathingLabs Breathing Games Training Group; Control Group; Nintendo Wii Fit Training Group

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.).

Nintendo Wii Fit Training Group

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).

BreathingLabs Breathing Games Training Group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Bronchiectasis diagnosis
• Stable clinical condition (no exacerbation in last 4 weeks)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation

Istanbul, 34060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, PT, PhD (c)

Study Record Dates

• First Submitted: July 27, 2019
• First Posted: July 31, 2019
• Study Start: July 27, 2019
• Primary Completion: February 6, 2021
• Study Completion: February 6, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

TU (1)