Video Based Breathing Exercise Rehabilitation

NCT06125990 | Completed

• 1 other identifier: VideoBasedRehab
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder; Down Syndrome

Keywords

breathing exercise; video based game; biofeedback

Outcome Measures

Primary Outcomes (4)

• FVC Measurement

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

  Change from baseline lungs volumes at 6 weeks.

• FEV1 Measurement

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

  Change from baseline lungs volumes at 6 weeks.

• FEV1/FVC Measurement

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

  Change from baseline lungs volumes at 6 weeks.

• 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 Outcomes (2)

• Pulse measurement

  Change from baseline lungs volumes at 6 weeks.

• Saturation measurement

  Change from baseline lungs volumes at 6 weeks.

Study Arms (2)

Study Group (SGr)

EXPERIMENTAL

In addition to institutional conventional rehabilitation, this group included breathing exercises to increase lung volumes and a 21-minute breathing exercise with video-based biofeedback.

Other: Experimental: Study Group (SGr)

Control Group (CGr)

SHAM COMPARATOR

This group was given only institutional conventional rehabilitation.

Other: Sham Comparator: Control Group (CGr)

Interventions

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.

Study Group (SGr)

Sham Comparator: Control Group (CGr) OTHER

Only institutional conventional rehabilitation was implemented.

Control Group (CGr)

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Volunteer of the family to participate in the study
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead
• Istanbul Gedik University: collaborator

Study Sites (1)

Istanbul Gedik University Barrier-Free Life Center

Istanbul, Turkey (Türkiye)

Location

Related 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.

  PMID: 30801256 BACKGROUND

• 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.

  PMID: 35669989 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Down Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Each children were be interviewed and evaluated alone.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: November 13, 2023
• Study Start: April 14, 2023
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-04

Locations

TU (1)