Video Based Breathing Exercise Rehabilitation

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06125990
• Other study ID #: VideoBasedRehab
• Status: Completed
• Phase: N/A
• Start date: April 14, 2023
• Est. completion date: August 14, 2023

Study information

• Verified date: April 2023
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 14, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Down Syndrome

Intervention

Other:
• Experimental: Study Group (SGr)
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)
Only institutional conventional rehabilitation was implemented.

Locations

Country	Name	City	State
Turkey	Istanbul Gedik University Barrier-Free Life Center	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi	Istanbul Gedik University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Simmich J, Deacon AJ, Russell TG. Active Video Games for Rehabilitation in Respiratory Conditions: Systematic Review and Meta-Analysis. JMIR Serious Games. 2019 Feb 25;7(1):e10116. doi: 10.2196/10116. — View Citation

Ucgun H, Gurses HN, Kaya M, Cakir E. Video game-based exercise in children and adolescents with non-cystic fibrosis bronchiectasis: A randomized comparative study of aerobic and breathing exercises. Pediatr Pulmonol. 2022 Sep;57(9):2207-2217. doi: 10.1002/ppul.26026. Epub 2022 Jun 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FVC Measurement	Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated.	Change from baseline lungs volumes at 6 weeks.
Primary	FEV1 Measurement	Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated.	Change from baseline lungs volumes at 6 weeks.
Primary	FEV1/FVC Measurement	Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated.	Change from baseline lungs volumes at 6 weeks.
Primary	PEF Measurement	Respiratory Function Test. The COSMED microQuark spirometer used. Positive airway flow rate was evaluated.	Change from baseline lungs volumes at 6 weeks.
Secondary	Pulse measurement	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.	Change from baseline lungs volumes at 6 weeks.
Secondary	Saturation measurement	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.	Change from baseline lungs volumes at 6 weeks.