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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

Primary Purpose

Bronchiectasis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional Chest Physiotherapy
Nintendo Wii Fit Based Exercise Training
BreathingLabs Breathing Games Based Exercise Training
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Bronchiectasis, Virtual Reality, Exercise Training, Pulmonary Function, Functional Capacity, 6 Minute Walk Test, Balance, Muscle Strength

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control Group

Nintendo Wii Fit Training Group

BreathingLabs Breathing Games Training Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 27, 2019
Last Updated
February 6, 2021
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT04038892
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 27, 2019 (Actual)
Primary Completion Date
February 6, 2021 (Actual)
Study Completion Date
February 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Bronchiectasis, Virtual Reality, Exercise Training, Pulmonary Function, Functional Capacity, 6 Minute Walk Test, Balance, Muscle Strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Nintendo Wii Fit Training Group
Arm Type
Experimental
Arm Description
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.
Arm Title
BreathingLabs Breathing Games Training Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Chest Physiotherapy
Intervention Description
Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage, coughing techniques and teaching respiratory control.
Intervention Type
Other
Intervention Name(s)
Nintendo Wii Fit Based Exercise Training
Intervention Description
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.).
Intervention Type
Other
Intervention Name(s)
BreathingLabs Breathing Games Based Exercise Training
Intervention Description
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 Measure Information:
Title
Respiratory Function Test
Description
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Time Frame
Eight weeks
Title
Respiratory Function Test
Description
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Time Frame
Eight weeks
Title
Respiratory Function Test
Description
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Time Frame
Eight weeks
Title
Respiratory Muscle Strength
Description
Change from baseline maximum inspiratory pressure (MIP) at 8 weeks
Time Frame
Eight weeks
Title
Respiratory Muscle Strength
Description
Change from baseline maximum expiratory pressure (MEP) at 8 weeks
Time Frame
Eight weeks
Title
Functional Capacity
Description
Change from baseline distance covered in six-minute walk test at 8 weeks
Time Frame
Eight weeks
Title
Balance
Description
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
Time Frame
Eight weeks
Title
Balance
Description
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Time Frame
Eight weeks
Title
Balance
Description
Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks
Time Frame
Eight weeks
Title
Peripheral Muscle Strength
Description
Change from baseline M. Quadriceps strength at 8 weeks
Time Frame
Eight weeks
Title
Peripheral Muscle Strength
Description
Change from baseline M. Biceps strength at 8 weeks
Time Frame
Eight weeks
Title
Peripheral Muscle Strength
Description
Change from baseline handgrip strength at 8 weeks
Time Frame
Eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation
City
Istanbul
ZIP/Postal Code
34060
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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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