Video Based Breathing Exercise Rehabilitation

Sponsor
Saglik Bilimleri Universitesi (Other)
Overall Status
Completed
CT.gov ID
NCT06125990
Collaborator
Istanbul Gedik University (Other)
18
1
2
4
4.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Experimental: Study Group (SGr)
  • Other: Sham Comparator: Control Group (CGr)
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
Single (Participant)
Masking Description:
Each children were be interviewed and evaluated alone.
Primary Purpose:
Treatment
Official Title:
Effect of Video Game-Based Lung Volume Increasing Training on Respiratory Mechanics in Children With Developmental Delays: Randomized Controlled Study
Actual Study Start Date :
Apr 14, 2023
Actual Primary Completion Date :
Aug 14, 2023
Actual Study Completion Date :
Aug 14, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Group (SGr)

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)
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)

This group was given only institutional conventional rehabilitation.

Other: Sham Comparator: Control Group (CGr)
Only institutional conventional rehabilitation was implemented.

Outcome Measures

Primary Outcome Measures

  1. FVC Measurement [Change from baseline lungs volumes at 6 weeks.]

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

  2. FEV1 Measurement [Change from baseline lungs volumes at 6 weeks.]

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

  3. FEV1/FVC Measurement [Change from baseline lungs volumes at 6 weeks.]

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

  4. PEF Measurement [Change from baseline lungs volumes at 6 weeks.]

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

Secondary Outcome Measures

  1. Pulse measurement [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Gedik University Barrier-Free Life Center Istanbul Turkey

Sponsors and Collaborators

  • Saglik Bilimleri Universitesi
  • Istanbul Gedik University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Saglik Bilimleri Universitesi
ClinicalTrials.gov Identifier:
NCT06125990
Other Study ID Numbers:
  • VideoBasedRehab
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Saglik Bilimleri Universitesi
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2023