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

February 2, 2026 updated by: Helene Alexanderson, Karolinska University Hospital

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.

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 161 76
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Completely symptom-free patients, not understanding Swedish language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breathing retraining and advice on physical activity
5 minutes of daily diaphragma breathing training, three times per day for 4 weeks
Other: Breathing training
Home-based breathing training with written and oral instructions performed 3 x 5 minutes per day for 4 weeks.
Other: Standrad advice about physical activity
Written, standard advice about physical activity at baseline
Active Comparator: Standard advice about physical activity
Written and oral advice about physical activity at baseline
Other: Standrad advice about physical activity
Written, standard advice about physical activity at baseline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Self-reported quality of life in three domains; Asthma symptoms, Activity limitation and Emotional. Contains 32 items. Completed on paper.
Change from baseline in quality of life at 4 weeks. Follow-up at 12 and 24 weeks
Paediatric Asthma Quality of Life Questionnaire
Time Frame: Assessed at baseline, after 4 weeks of intervention, at 12 weeks and 24 weeks follow-up
Self-reported quality of life in three domains - symptoms, activity limitation and emotional
Assessed at baseline, after 4 weeks of intervention, at 12 weeks and 24 weeks follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Paediatric Nijmegen Questionnaire
Time Frame: Change from baseline in breathing problems at 4 weeks, with follow-up at 12 and 24 weeks
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.
Change from baseline in breathing problems at 4 weeks, with follow-up at 12 and 24 weeks
Saltin-Grimby Physical Activity Scale
Time Frame: Changes from baseline in physical activity levels at 4 weeks with follow-up at 12 and 24 weeks
Self-reported physical activity level.
Changes from baseline in physical activity levels at 4 weeks with follow-up at 12 and 24 weeks
Childhood / Adult Asthma Control Test (c-ACT / ACT)
Time Frame: Changes from baseline after 4 weeks of intervention, follow-up at 12 and 24 weeks
Self-reported control of different asthma signs, 10 imems
Changes from baseline after 4 weeks of intervention, follow-up at 12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Investigators

  • Principal Investigator: Helene Alexanderson, Associate professor, PhD, RPT, Medical Unit Allied Health Professionals, Karolinska University Hospital, Stockholm, sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KarolinskaUH
  • F2020-0009 (Other Grant/Funding Number: Swedish Asthma and Allergy Society)
  • 2023-01011 (Other Grant/Funding Number: Promobilia Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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