Active Airways for Children and Young People With Asthma

N/ANot Yet RecruitingNCT07643753

University of Leicester60 enrolled

Overview

What is this study about? The investigators want to see if exercise and education sessions can help children and young people (aged 10-17) with asthma, manage the participants asthma better. The investigators will place participants that are recruited to this study into one of three groups by a computer (randomly): Group 1: Usual Care: Continue with normal asthma treatment. Group 2: Education: Usual care + a 45-minute online asthma education class once a week. Group 3: Exercise \& Education: Usual care + 3 exercise sessions a week and asthma education classes.

This research aims to identify if an exercise and/or asthma education programme, called 'Active Airways', is feasible and acceptable in the paediatric asthma patient. Feasibility, the primary outcome of this study, will be evaluated by calculating the percentage of people approached who participate in the intervention (recruitment) and the percentage who complete the intervention (retention and adherence). The investigators also want to see if the Active Airways programme could improve cardiorespiratory fitness, quality of life and lung function, reduce asthma attacks and reduce healthcare use.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Asthma Childhood Exercise

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: Willing and able to consent to participate in the trial Able to understand written and spoken English A diagnosis of Mild to Moderate Asthma or Severe Asthma based on the European Respiratory Society (ERS)/ American Thoracic Society (ATS) consensus statement on Severe Asthma Able to participate in a formal exercise programme Aged 10-17 years Able to engage in focus groups Approximately 130cm tall (to be able to complete cardiopulmonary exercise testing (CPET)) Exclusion Criteria: Self-reported uncontrolled severe exercise-induced breathlessness Required a course of antibiotics or oral corticosteroids within the 4 weeks prior to the study commencing Children with severe co-morbidities that will not allow them to participate in an exercise programme e.g. Severe neuromuscular disorders, recent fractures or surgeries, cognitive or behavioural conditions. Participant is unable or unwilling, in the opinion of the investigator, to give informed consent

Outcomes

Primary Outcomes

Recruitment

The percentage of children approached who participate in the intervention (recruitment)

Time frame: 12 weeks

Retention

The percentage of participants that complete the intervention with a retention rate of \>70%

Time frame: 12 weeks

Secondary Outcomes

Adherence to programme

Participant engagement measured through attendance rates.

Time frame: 12 weeks

Wrist worn accelerometers

Device wear time compliance during the 12-week study, aiming for =\>10 hours a day

Time frame: 12 weeks

Focus groups on patients experience to barriers to an exercise programme

Lived experience of the barriers for children with asthma to taking part in an exercise programme, measured through qualitative focus groups.

Time frame: 12 weeks

Health beliefs

Baseline demographics from participants will be recorded from medical records

Time frame: 12 weeks

Respiratory (throat) samples

Throat samples will be taken and microbial analysis for assessing microbial diversity through 16S rRNA sequencing, to provide relative abundance of bacterial groups. A greater bacterial diversity in the respiratory sample is considered a sign of heathier and more resilient microbial community. This could lead to fewer asthma exacerbations and better asthma control.

Time frame: Baseline, 12 weeks, 6 months and 1 year.

Quality of life of participants using the paeditric quality of life inventory (asthma module)

Measured through the paediatric quality of life asthma module to measure how asthma affects the health-related quality of life using 28 items divided into 4 domains, higher scores mean better quality of life and lower scores mean greater asthma-related impairment.

Time frame: Baseline, 12 weeks, 6 months and 1 year

Effectiveness of the programme

Cardiorespiratory fitness (maximal oxygen uptake measured by VO2 max)

Time frame: Baseline, 12 weeks, 6 months and 1 year.

Respiratory (nasal) samples

Nasal samples will be taken and microbial analysis for assessing microbial diversity through 16S rRNA sequencing, to provide relative abundance of bacterial groups. A greater bacterial diversity in the respiratory sample is considered a sign of a heathier and more resilient microbial community. This could lead to fewer asthma exacerbations and better asthma control.

Time frame: Baseline, 12 weeks, 6 months and 1 year.

Gut samples

Stool samples will be taken and microbial analysis for assessing microbial diversity through 16S rRNA sequencing, to provide relative abundance of bacterial groups. A greater bacterial diversity in the stool sample is considered a sign of heathier and more resilient microbial community which could lead to fewer asthma exacerbations and better asthma control.

Time frame: Baseline, 12 weeks, 6 months and 1 year.

Focus groups on motivators for an exercise programme

Lived experience of the motivators for children and young people with asthma to taking part in an exercise programme, measured through qualitative focus groups.

Time frame: 12 weeks

Active Airways for Children and Young People With Asthma

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts