NCT07643753

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
51mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

June 11, 2026

Status Verified

May 1, 2026

Enrollment Period

2.9 years

First QC Date

May 10, 2026

Last Update Submit

June 9, 2026

Conditions

Asthma ChildhoodExerciseChildren

Keywords

asthmachildrenexercisephysical activity

Outcome Measures

Primary Outcomes (2)

  • Recruitment

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

    12 weeks

  • Retention

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

    12 weeks

Secondary Outcomes (10)

  • Adherence to programme

    12 weeks

  • Wrist worn accelerometers

    12 weeks

  • Focus groups on patients experience to barriers to an exercise programme

    12 weeks

  • Health beliefs

    12 weeks

  • Respiratory (throat) samples

    Baseline, 12 weeks, 6 months and 1 year.

  • +5 more secondary outcomes

Study Arms (3)

Group 1- usual care

NO INTERVENTION

Participants will continue to receive usual care from their asthma team/ provider

Group 2- education

ACTIVE COMPARATOR

Participants will receive a 12 week education class on exercise

Other: education

Group 3- exercise

ACTIVE COMPARATOR

Participants will take part in a 12 week interval exercise class

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATIONOther: education

Interventions

EXERCISE TRAINING WITH OR WITHOUT MEDICATIONOTHER

12 week interval exercise training programme and 12 week education on exercise with asthma

Also known as: exercise
Group 3- exercise
educationOTHER

education on exercise and asthma

Group 2- educationGroup 3- exercise

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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))

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leicester

Leicester, United Kingdom

Location

MeSH Terms

Conditions

Motor ActivityAsthma

Interventions

ExerciseDosage FormsEducational Status

Condition Hierarchy (Ancestors)

BehaviorBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative TechniquesSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Erol Gaillard

    University of Leicester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naomi Dayman

CONTACT

07487506547nad21@leicester.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: There are three groups for the active airways study: Group 1- usual care Group 2- education only Group 3- exercise and education programme
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2026

First Posted

June 11, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

September 1, 2030

Last Updated

June 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)