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Paediatric AsthmaNCT07397676

Quality of Life - Effects of a Physical Therapy Intervention to for Children and Adolescents With Asthma

A study testing Breathing training and Standrad advice about physical activity in people with Paediatric Asthma and Paediatric Dysfunctional Breathing, run by Karolinska University Hospital at 1 site in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Many children and adolescents with asthma have dysfunctional breathing, e.g. they use mainly upper chest muscles to breath and do not engage the diaphragma muscle when breathing. This can lead to a variety of breathin problems such as dizzyness, muscle tension, and limitations in ability to be physically active. Read more about this study

Who is it for?
Ages 10 to 17 years
What is being tested?
Breathing training and Standrad advice about physical activity
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSweden
Study dates
30 Aug 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age 10-17, diagnosis of atopic and/or exercise-induced asthma, referred to physiotherapy.

Who cannot join

  • Completely symptom-free patients, not understanding Swedish language

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Karolinska University Hospital

    Stockholm, 161 76

Other trials in Sweden

About this study

Official title: Effects of Breathing Technique Training and Physical Activity Counseling on Quality of Life, Symptoms, Asthma Control, and Physical Activity in Children and Adolescents With Asthma: A Randomized Controlled Trial

Many children and adolescents with asthma have dysfunctional breathing, e.g. they use mainly upper chest muscles to breath and do not engage the diaphragma muscle when breathing. This can lead to a variety of breathin problems such as dizzyness, muscle tension, and limitations in ability to be physically active. As of today there is no guidelines for treatment or follow-up for these patients and there are very few well-perfomed studies evaluating if breathin retraining can improve breathing pattern.

The aim of this study is to examine the effects of breathing training and advice on physical activity compared to only advice on physical activity in children and adolescents with asthma. The primary outcome is quality of life and secondary outcomes are dysfunctional breathing, asthma control, physical activity level and spirometry changes.

Read more

This randomized controlled trial.

Patients are identified at the paediatric lung clinic at Karolinska University Hospital, and patients aged 10-17 years who are reffered to see a physiotherapist for spirometry and exercise testing who have with asthma who have dysfunctional breathing are invited to participate.

Assessments include the Paediatric Asthma Quality of Life Questionnaire, Parent Asthma Quality of Life Questionnaire, The Paediatric Nijmegen Questionnaire assessing symtpoms associated to dysfunctional breathing, the Childhood Asthma control test or the adult asthma control test. These questionnaires as completed by patients with or without their parents depending on their age at baseline, and after 4 weeks, 12 weeks and 24 weeks. At baseline and after 4 weeks an exercise tolerance test of 8 minutes performed on a treadmill and spirometry are performed.

Interventions:

Acitve intervention means diaphragmal breathing training 5 days a week for

Read the detailed description

Study Protocol for ClinicalTrials.gov

Study Title Effects of Breathing Technique Training and Physical Activity Counseling on Quality of Life, Symptoms, Asthma Control, and Physical Activity in Children and Adolescents With Asthma: A Randomized Controlled Trial

Brief Summary This randomized controlled trial aims to evaluate the effects of training in low-costal and diaphragmatic breathing techniques combined with counseling on physical activity according to FYSS, compared with standard care-physical activity counseling according to FYSS alone-on quality of life, symptoms related to dysfunctional breathing, asthma control, and physical activity levels in children and adolescents with asthma.

Approximately 70 patients referred to a physical therapist at Karolinska University Hospital (Huddinge and Solna) will be invited to participate over one year. Participants will be randomized to either (1) an intervention group receiving extended physiotherapy including breathing training, inhalation technique, and individualized physical activity advice, or (2) a control group receiving standard physical activity recommendations according to FYSS.

The primary outcome is health-related quality of life measured by the Pediatric Asthma Quality of Life Questionnaire (PAQLQ).

Detailed Description This study investigates whether adding structured breathing training to standard physical activity recommendations improves quality of life, dysfunctional breathing symptoms, asthma control, and physical activity levels among children and adolescents aged 10-17 with atopic and/or exercise-induced asthma.

Participants randomized to the intervention group will receive training in low-costal/diaphragmatic breathing, individualized physical activity advice, and inhalation technique training. Diaphragmatic breathing will be practiced 3 times per day for 3-5 minutes. The control group will receive standard physical activity advice based on FYSS guidelines.

Measurements will be taken before and after a 4-week intervention, and at 12- and 24-week follow-ups. Independent physiotherapists at each site will perform all assessments.

Study Design Study Type: Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single-blinded (Outcome Assessors) Primary Purpose: Treatment Estimated Enrollment: 63 participants Study Duration: 24 weeks follow-up Study Sites: Karolinska University Hospital, Huddinge and Solna

Interventions Intervention Group: Breathing Training + Physical Activity Counseling

  • Low-costal/diaphragmatic breathing training (3×/day, 3-5 min)
  • Inhalation technique training
  • Individualized physical activity advice according to FYSS

Control Group: Standard Physical Activity Counseling (FYSS)

  • Aerobic and muscle-strengthening recommendations
  • For exercise-induced symptoms: ICS, bronchodilators, gradual warm-up

Outcome Measures Primary Outcome: PAQLQ Secondary Outcomes: Nijmegen Questionnaire, Actigraph accelerometry, ACT, spirometry, treadmill test.

Eligibility Criteria Inclusion: Age 10-17, diagnosis of atopic and/or exercise-induced asthma, referred to physiotherapy.

Exclusion: Completely symptom-free patients.

Study Procedures Baseline: PAQLQ, ACT, Nijmegen Questionnaire, Spirometry, Exercise Test, Accelerometer (14 days).

Intervention Period: 4 weeks. Follow-ups: Week 4, 12, 24.

Being tested
Breathing training, Standrad advice about physical activity
Keywords
Physical activity, Breathing retraining, Quality of life, Dysfunctional breathing
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breathing trainingOther

    Home-based breathing training with written and oral instructions performed 3 x 5 minutes per day for 4 weeks.

  • Standrad advice about physical activityOther

    Written, standard advice about physical activity at baseline

Study groups in NCT07397676
Study groupRoleWhat they receive
Breathing retraining and advice on physical activityExperimental5 minutes of daily diaphragma breathing training, three times per day for 4 weeks
Receives: Other: Breathing training; Other: Standrad advice about physical activity
Standard advice about physical activityActive comparatorWritten and oral advice about physical activity at baseline
Receives: Other: Standrad advice about physical activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Paediatric Asthma Quality of Life Questionnaire

    Self-reported quality of life in three domains; Asthma symptoms, Activity limitation and Emotional. Contains 32 items. Completed on paper.

    Measured: Change from baseline in quality of life at 4 weeks. Follow-up at 12 and 24 weeks

  2. Paediatric Asthma Quality of Life Questionnaire

    Self-reported quality of life in three domains - symptoms, activity limitation and emotional

    Measured: Assessed at baseline, after 4 weeks of intervention, at 12 weeks and 24 weeks follow-up

Secondary outcomes (3)
  1. Paediatric Nijmegen Questionnaire

    A newly validated questionnaire to assess symptoms related to dysfunctional breathing for children and adolescents with or with out asthma. Includes 16 items. Based on the original adult Nijmegen Questionnaire.

    Measured: Change from baseline in breathing problems at 4 weeks, with follow-up at 12 and 24 weeks

  2. Saltin-Grimby Physical Activity Scale

    Self-reported physical activity level.

    Measured: Changes from baseline in physical activity levels at 4 weeks with follow-up at 12 and 24 weeks

  3. Childhood / Adult Asthma Control Test (c-ACT / ACT)

    Self-reported control of different asthma signs, 10 imems

    Measured: Changes from baseline after 4 weeks of intervention, follow-up at 12 and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start30 Aug 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Four weeks of randomiazed controlled interventions vs control intervention with an additional 20-week single group follow-up
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07397676
Sponsor's protocol ID
KarolinskaUH
Other IDs
F2020-0009, 2023-01011, 2023
Status last verified
Feb 2026
First submitted
2 Feb 2026
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: This is not a a clinical trial investigating safety or effects of a drug and is not funded or organized by NIH. However, we want to share our dataset and statistical analysis accoring to guidelines by the scientific journal who accepts our manuscripts. We would also consider to share results on clincialtrials.gov.

Publications

  • Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur Respir J. 1999 Jul;14(1):32-8. doi: 10.1034/j.1399-3003.1999.14a08.x.

    PubMed 10489826
  • Juniper EF, Guyatt GH, Feeny DH, Griffith LE, Ferrie PJ. Minimum skills required by children to complete health-related quality of life instruments for asthma: comparison of measurement properties. Eur Respir J. 1997 Oct;10(10):2285-94. doi: 10.1183/09031936.97.10102285.

    PubMed 9387955
  • van Dixhoorn J, Duivenvoorden HJ. Efficacy of Nijmegen Questionnaire in recognition of the hyperventilation syndrome. J Psychosom Res. 1985;29(2):199-206. doi: 10.1016/0022-3999(85)90042-x.

    PubMed 4009520
  • Thomas M, McKinley RK, Freeman E, Foy C, Prodger P, Price D. Breathing retraining for dysfunctional breathing in asthma: a randomised controlled trial. Thorax. 2003 Feb;58(2):110-5. doi: 10.1136/thorax.58.2.110.

    PubMed 12554890
  • Agache I, Ciobanu C, Paul G, Rogozea L. Dysfunctional breathing phenotype in adults with asthma - incidence and risk factors. Clin Transl Allergy. 2012 Sep 19;2(1):18. doi: 10.1186/2045-7022-2-18.

    PubMed 22992302
  • Hepworth C, Sinha I, Saint GL, Hawcutt DB. Assessing the impact of breathing retraining on asthma symptoms and dysfunctional breathing in children. Pediatr Pulmonol. 2019 Jun;54(6):706-712. doi: 10.1002/ppul.24300. Epub 2019 Apr 1.

    PubMed 30938089
  • Merikallio VJ, Mustalahti K, Remes ST, Valovirta EJ, Kaila M. Comparison of quality of life between asthmatic and healthy school children. Pediatr Allergy Immunol. 2005 Jun;16(4):332-40. doi: 10.1111/j.1399-3038.2005.00286.x.

    PubMed 15943597
  • Bateman ED, Hurd SS, Barnes PJ, Bousquet J, Drazen JM, FitzGerald JM, Gibson P, Ohta K, O'Byrne P, Pedersen SE, Pizzichini E, Sullivan SD, Wenzel SE, Zar HJ. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J. 2008 Jan;31(1):143-78. doi: 10.1183/09031936.00138707.

    PubMed 18166595

Questions about this trial

What is this clinical trial studying?

A study testing Breathing training and Standrad advice about physical activity in people with Paediatric Asthma and Paediatric Dysfunctional Breathing, run by Karolinska University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Paediatric Asthma Quality of Life Questionnaire (time frame: Change from baseline in quality of life at 4 weeks. Follow-up at 12 and 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07397676, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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