UnknownNot Applicable

The Effect of Physiotherapy on Dysfunctional Breathing in Children and Adolescents With and Without Asthma

Denmark140 participantsStarted 2021-02-10

Plain-language summary

The purpose of the study is to investigate the effect of physiotherapeutical instructions on dysfunctional breathing in children and adolescents with or without asthma. Children and adolescents with dysfunctional breathing, are invited to participate in the intervention study. Participants are stratified by asthma diagnose status and randomized to physiotherapy or standard care. Participants are followed a year after the intervention, to compare the development in asthma control ( if asthma) and quality of life.

Who can participate

Age range

10 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Asthma group: * Asthma diagnosed by lung function tests and/or typical symptoms. * Treatment with inhaled corticosteroids in minimum 3 months. * ACQ5 \>= 1.5. * NQ \>= 23. NonAsthma group * Asthma denied after lung function tests ( exercise challenge or mannitol challenge) * NQ \>= 23. Exclusion Criteria: * Other significant cardiopulmonary or muscoluskeletal conditions. * Complex functional conditions involving other organ systems. * patients who already had the physotherapeutical intervention before study start.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in Asthma Control Questionnaire ( ACQ5) at 6 months.

Timeframe: ACQ is taken at baseline and 6 months after intervention as primary outcome.

Change from baseline in Pediatric Quality of Life Inventory ( PedsQl) at 6 months

Timeframe: PedsQL is taken at baseline and 6 months after intervention as primary outcome.

Trial details

NCT IDNCT04728191

SponsorKolding Sygehus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12

Contact for this trial

Signe Vahlkvist, PhD

+45 20 23 14 30 Signe.Vahlkvist@rsyd.dk

View on ClinicalTrials.gov More Dysfunctional Breathing trials