Clinical trial NCT06546566: Video Game-Based and Conventional Breathing Exercises on Pulmonary and Extrapulmonary Features in Children with Asthma
Official title: Effects of Video Game-Based and Conventional Breathing Exercises on Pulmonary and Extrapulmonary Features in Children with Asthma: a Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Keywords: asthma
children
conventional breathing exercises
video game-based breathing exercise
pulmonary function
respiratory muscle strength
peripheral muscle strength
functional capacity
quality of life
asthma control
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 34
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Conventional breathing exercises are recommended as a support to drug therapy, which is the primary treatment modality for symptom management in asthma patients. Video game-based applications are current approaches that enable exercises to be performed more fun, motivating, freely, and safely. The number of studies using video game-based approach as a respiratory exercise method is limited and no such study has been found in children with asthma. The aim of our study was to compare the effects of video game-based breathing exercises and conventional breathing exercises on pulmonary and extrapulmonary features in children with asthma.

Thirty-four children with asthma aged 8-18 years will be included in the study. Participants will be randomly divided into 2 groups as control group and experimental group. Demographic and clinical features of the patients will be recorded. Pulmonary function, respiratory muscle strength, dyspnea, fatigue, functional capacity, peripheral muscle strength, level of asthma control, and quality of life will be assessed by the spirometer, intraoral pressure measuring device, the Modified Borg Scale, the Fatigue Impact Scale, Spiropalm 6-min walk test, digital handheld manuel muscle tester, hydraulic hand dynamometer, asthma control test, and the Pediatric Quality of Life Inventory, respectively. Additionally, patient's adherence to the exercise program will be assessed by exercise diary. All assessments will be repeated before and after treatment.

Exercise training will be given to the patients for 8 weeks, 5 days a week, 30 minutes a day. The control group will receive home-based conventional breathing exercises; the experimental group will receive video game-based exercises consisting of breathing games. The exercise program will consist of the breathing games in the BreathingLabs game kit. In addition, relaxation techniques will be taught and physical activity recommendations will be given to the both groups.


Eligibility criteria: Inclusion Criteria:

* 8-18 years of age
* Being clinically diagnosed with asthma
* Being able to walk, cooperate, and clinically stable
* Having a computer, tablet, or mobile phone for the patients who will take part in the experimental group
* Volunteering to participate in the study

Exclusion Criteria:

* Upper respiratory tract infection or asthma attack in the last three weeks prior to participation in the study
* A history of hospitalisation within the last three weeks prior to participation in the study
* Having an upper respiratory tract infection or asthma attack or a history of hospitalisation during the exercise training programme
* Having a history of changes in medication used in the last three weeks prior to participation in the study
* History of previous lung or liver transplantation
* Having secondary diseases such as kyphoscoliosis etc. that may affect respiratory function
* Participation in ongoing or regular exercise training within the last 1 year
* Having completed less than 80% of the sessions that should be completed in total at the end of the treatment

Primary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: 8 weeks
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 8 weeks
measure: Peak Expiratory Flow (PEF)
timeFrame: 8 weeks
measure: Forced Expiratory Flow 25-75% (FEF25-75)
timeFrame: 8 weeks
measure: Maximal Inspiratory Pressure (MIP)
timeFrame: 8 weeks
measure: Maximal Expiratory Pressure (MEP)
timeFrame: 8 weeks
measure: Level of Dyspnea
timeFrame: 8 weeks
measure: Level of Fatigue
timeFrame: 8 weeks
measure: Spiropalm 6-minute Walk Test
timeFrame: 8 weeks
measure: M. Quadriceps Muscle Strength
timeFrame: 8 weeks
measure: M. Biceps Muscle Strength
timeFrame: 8 weeks
measure: Handgrip Strength
timeFrame: 8 weeks
measure: Level of Asthma Control
timeFrame: 8 weeks
measure: Level of Quality of Life
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Atlas University
Study officials:
affiliation: Atlas University
name: Hikmet Ucgun, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: