Skip to main content
OpenTrials
Completed

NCT Number: NCT06125990

Video Based Breathing Exercise Rehabilitation

The aim of the study was to investigate the effect of video game-based lung volume increasing training on respiratory mechanics in children with developmental delays. Individuals with special needs are people who, for various reasons, show significant awareness at the level expected from their peers in terms of their individual characteristics and educational qualifications. Individuals with special needs constitute an important part of our country. Children with special needs may have respiratory problems that may or may not be recognized because they are not diagnosed, as well as decreases in respiratory capacity. Decrease in lung volumes may be encountered in children with special needs with various diagnoses such as neuromuscular diseases, cerebral palsy, cystic fibrosis, autism, and Down syndrome.

Pulmonary rehabilitation is a multidisciplinary program that balances or reverses the physiopsychopathology of pulmonary disorders and tries to help the patient reach high functional capacity as much as his physical condition and pulmonary disability allow. Chest physiotherapy, which is an important step of pulmonary rehabilitation, is a rehabilitation intervention used to reduce airway resistance, improve gas exchange and facilitate breathing in children. Active video game systems produced with the development of new technologies are used for the positive progression of rehabilitation, especially in young individuals who are extensive users of digital devices. For children who need a pulmonary rehabilitation program, active video game systems are preferred in the clinic as they increase the compatibility of the sessions and ensure continuity.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Abnormalities, Multiple Child Development Disorders, Pervasive Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Gedik University Barrier-Free Life Center

Istanbul, Turkey (Türkiye)

About this study

It seems that there are insufficient studies in the literature on the effects of exercises that increase lung capacity on children with special needs. To the best of our knowledge, there is no study investigating the effects of programs to increase lung volumes in children with special needs in a randomized controlled study design. With this project, we aimed to reveal the effects of a lung volume-increasing exercise program performed with a video-based game system applied for 6 weeks in children with special needs, by comparing it with the control group that received only conventional rehabilitation. The duration of the treatment program in our study is also one of our unique values. According to our literature research, the implementation of a lung capacity-increasing rehabilitation program in children with special needs in the form of supervision twice a week and a home program once a week for 6 weeks is the first.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Volunteer of the family to participate in the study
  • Stable clinical status at inclusion without infection or exacerbation in the previous 4 weeks
  • Children who have not been included in another clinical trial within the last month
  • Participants with a Body Mass Index (BMI) below 30 kilograms/square meter

Exclusion criteria

  • Those with severe comorbidities, unstable coronary artery disease, collagen vascular diseases, and those requiring high-flow oxygen therapy (3-4 L\\min).
  • History of exertional syncope or any comorbidity that prevents exercise training
  • Inability to communicate with the child and the child not obeying commands in any way
  • Children with vision problems

Treatment and study plan

Experimental: Study Group (SGr)

Other

For 6 weeks, in addition to institutional conventional exercise 2 days a week, one day a week of home exercise, breathing exercises to increase lung volumes and 7 sets of video-based breathing exercises were applied, each set consisting of 2 minutes of performance and 1 minute of rest.

Sham Comparator: Control Group (CGr)

Other

Only institutional conventional rehabilitation was implemented.

Primary outcomes

  1. FVC Measurement

    Time frame: Change from baseline lungs volumes at 6 weeks.

    Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated.

  2. FEV1 Measurement

    Time frame: Change from baseline lungs volumes at 6 weeks.

    Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated.

  3. FEV1/FVC Measurement

    Time frame: Change from baseline lungs volumes at 6 weeks.

    Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated.

  4. PEF Measurement

    Time frame: Change from baseline lungs volumes at 6 weeks.

    Respiratory Function Test. The COSMED microQuark spirometer used. Positive airway flow rate was evaluated.

Secondary outcomes

  1. Pulse measurement

    Time frame: Change from baseline lungs volumes at 6 weeks.

    In order to ensure exercise safety, exercise sessions were carried out by monitoring pulse and saturation values with a pulse oximeter before, during and during exercises that increase lung volumes.

  2. Saturation measurement

    Time frame: Change from baseline lungs volumes at 6 weeks.

    In order to ensure exercise safety, exercise sessions were carried out by monitoring pulse and saturation values with a pulse oximeter before, during and during exercises that increase lung volumes.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Collaborators

  • Istanbul Gedik University

Registry information

Official study title

Effect of Video Game-Based Lung Volume Increasing Training on Respiratory Mechanics in Children With Developmental Delays: Randomized Controlled Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 13, 2023
Registry last updated
Nov 13, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.