AsthmaEmBRAiZNCT05531370
Implementation of Evidence-based Breathing Retraining for Patients With Asthma in Region Zealand
A study testing Breathing Retraining in people with Asthma, run by Naestved Hospital at 1 site in Denmark.
Trial summary
This study aims to implement the evidence-based intervention breathing retraining into clinical care of patients with symptomatic asthma irrespective of asthma severity or comorbidities, and in a diverse multicentre setting to evaluate implementation outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Breathing Retraining
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Jun 2022to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Doctor diagnosed asthma;
- Incompletely controlled asthma or worse: Asthma Control Questionnaire (ACQ5) score ≥0.8;
- Residence (or asthma treatment program) in Region Zealand, Denmark;
- Able to read and understand Danish or available assistance to help understand information material, intervention content and respond to questionnaires.
Who cannot join
- Unwilling to participate;
- Unable to participate in the intervention due to physical or mental condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of Evidence-based Breathing Retraining for Patients With Asthma in Region Zealand, Denmark
This study aims to implement the evidence-based intervention breathing retraining into clinical care of patients with symptomatic asthma irrespective of asthma severity or comorbidities, and in a diverse multicentre setting to evaluate implementation outcomes. This will meet patients' needs and improve health and life situation in patients with uncontrolled asthma. Further, the study will evaluate implementation outcomes.
Read the detailed description
This study is a hybrid-designed prospective multicenter implementation evaluation study, in which the investigators secondarily will maintain measuring effectiveness of breathing retraining in a real-world setting including primary and secondary health care and add cross-sectorial co-operation. Thus, investigators include more primary outcomes.
The study is part of Exercise First-project, a collaboration of The National Health Service, Region Zealand and the research unit PROgrez, Department of Physiotherapy and Occupational Therapy at Næstved, Slagelse, Ringsted hospitals.
- Conditions
- Asthma
- Being tested
- Breathing Retraining
- Keywords
- Implementation, Asthma, Breathing Retraining
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing RetrainingOther
Also called Breathing Exercises
Conforming the real-world setting, all participants will continue standard asthma care, i.e., acute and planned visits at GP or pulmonologist.
BR aims to normalize the inhaled volume, nasal inhalation, exhalation to the resting position of the chest (functional residual capacity, FRC), use of the diaphragm muscle, and to move lower parts of the chest in a frequency of 12-16 per minute. This pattern is initially trained in rest (e.g., side lying or sitting), then during physical activity (e.g., walking). Uncontrolled coughing, frequent yawning or sighing is handled by a suppression technique. Relaxation technique is introduced as a separate activity but to be combined with the breathing pattern method to be used in both resting and as possible during physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Breathing Retraining (BR) | Experimental | Patients will receive three sessions (60 min, 30 min, 30 min) of breathing retraining (BR), 1-to-1 with a trained physiotherapist.
As preferred by the patient:
* Hybrid delivery mode of BR (H-BR): First session on-site at hospital/clinic for initial assessment and introduction, and following sessions online (MedComs VDX platform or equal; participants access using web cam and sound on smart phone, tablet, or pc).
* Ordinary delivery of BR: Three sessions on-site at hospital/clinic. Receives: Other: Breathing Retraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of intervention (Uptake)
Organization-related (Pulmonologists, general practioners, physiotherapists) outcome: Proportion of general practices and of hospitals that will adopt BR.
Measured: Through study completion, an average of 1 year
Implementation of intervention (Fidelity)
Organization-related (physiotherapists) outcome:
% of contents delivered as planned assessed by a checklist of key aspects in the breathing retraining-intervention.
Measured: Through study completion, an average of 1 year
Feasibility of online sessions in Hybrid delivery mode of BR (H-BR) (Acceptability)
Patient- and Organization-related (physiotherapists) outcome: assessed by a semi-structured interview.
Measured: Through study completion, an average of 1 year
Effectiveness: MiniAsthma Quality of Life Questionnaire, MiniAQLQ
Patient-related outcome, disease specific quality of life questionnaire. 7-point Likert scales from 1-7, 1 = worse outcome, 7 = better outcome.
Success rates of improvements minus deteriorations of individual effects, measured at 12 month follow up.
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
MiniAsthma Quality of Life Questionnaire, MiniAQLQ
Patient-related outcome: Mean of disease specific quality of life questionnaire. 7-point Likert scales from 1-7, 1 = worse outcome, 7 = better outcome.
Measured: Change from baseline to 12 months
Breathing pattern observation
Patient-related outcome. Pre-defined key aspects of the breathing pattern assessed qualitatively observation by the physiotherapist.
Measured: Change from baseline to 12 month
Objective physical activity level
Patient-related outcome. Objectively measured physical activity and inactivity using combined wearable thigh and wrist accelerometers, worn for seven consecutive days.
Measured: Change from baseline to 12 month
Objective steps per day (average)
Patient-related outcome. Objectively measured steps per day using combined wearable thigh and wrist accelerometers, worn for seven consecutive days.
Measured: Change from baseline to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start30 Jun 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Søren T Skou, Prof., Study chair, Naestved-Slagelse-Ringsted Hospitals; University of Southern DenmarkLars H Tang, Assoc.Prof., Study chair, Naestved-Slagelse-Ringsted Hospitals; University of Southern DenmarkCecilie L Egholm, PostDoc., Study chair, Naestved-Slagelse-Ringsted Hospitals, DenmarkUffe Bodtger, Prof., Study chair, Zealand University Hospital; University of Southern DenmarkMike Thomas, Prof., Study chair, Primary Care Research University of Southampton, UKKaren H Andreasson, Dr., Principal investigator, Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531370
- Sponsor's protocol ID
- EMN-2022-01229
- Acronym
- EmBRAiZ
- Status last verified
- Jun 2026
- First submitted
- 4 Jul 2022
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Evidence-based Breathing Retraining for Patients With Asthma in Region Zealand, Denmark
- ClinicalTrials.gov ID
- NCT05531370
- Acronym / sponsor ID
- EmBRAiZ / EMN-2022-01229
- Conditions
- Asthma
- Keywords
- Implementation, Asthma, Breathing Retraining
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to implement the evidence-based intervention breathing retraining into clinical care of patients with symptomatic asthma irrespective of asthma severity or comorbidities, and in a diverse multicentre setting to evaluate implementation outcomes. This will meet patients' needs and improve health and life situation in patients with uncontrolled asthma. Further, the study will evaluate implementation outcomes.
Detailed description
This study is a hybrid-designed prospective multicenter implementation evaluation study, in which the investigators secondarily will maintain measuring effectiveness of breathing retraining in a real-world setting including primary and secondary health care and add cross-sectorial co-operation. Thus, investigators include more primary outcomes.
The study is part of Exercise First-project, a collaboration of The National Health Service, Region Zealand and the research unit PROgrez, Department of Physiotherapy and Occupational Therapy at Næstved, Slagelse, Ringsted hospitals.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breathing Retraining (BR) | Experimental | Other: Breathing RetrainingPatients will receive three sessions (60 min, 30 min, 30 min) of breathing retraining (BR), 1-to-1 with a trained physiotherapist. As preferred by the patient: * Hybrid delivery mode of BR (H-BR): First session on-site at hospital/clinic for initial assessment and introduction, and following sessions online (MedComs VDX platform or equal; participants access using web cam and sound on smart phone, tablet, or pc). * Ordinary delivery of BR: Three sessions on-site at hospital/clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Doctor diagnosed asthma;
- Incompletely controlled asthma or worse: Asthma Control Questionnaire (ACQ5) score ≥0.8;
- Residence (or asthma treatment program) in Region Zealand, Denmark;
- Able to read and understand Danish or available assistance to help understand information material, intervention content and respond to questionnaires.
Key exclusion criteria (2 listed)
- Unwilling to participate;
- Unable to participate in the intervention due to physical or mental condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing RetrainingAlso: Breathing ExercisesConforming the real-world setting, all participants will continue standard asthma care, i.e., acute and planned visits at GP or pulmonologist. BR aims to normalize the inhaled volume, nasal inhalation, exhalation to the resting position of the chest (functional residual capacity, FRC), use of the diaphragm muscle, and to move lower parts of the chest in a frequency of 12-16 per minute. This pattern is initially trained in rest (e.g., side lying or sitting), then during physical activity (e.g., walking). Uncontrolled coughing, frequent yawning or sighing is handled by a suppression technique. Relaxation technique is introduced as a separate activity but to be combined with the breathing pattern method to be used in both resting and as possible during physical activity. | Other | Breathing Retraining (BR) |
Primary outcome
Adoption of intervention (Uptake)
Time frame: Through study completion, an average of 1 year
Organization-related (Pulmonologists, general practioners, physiotherapists) outcome: Proportion of general practices and of hospitals that will adopt BR.
Implementation of intervention (Fidelity)
Time frame: Through study completion, an average of 1 year
Organization-related (physiotherapists) outcome: % of contents delivered as planned assessed by a checklist of key aspects in the breathing retraining-intervention.
Feasibility of online sessions in Hybrid delivery mode of BR (H-BR) (Acceptability)
Time frame: Through study completion, an average of 1 year
Patient- and Organization-related (physiotherapists) outcome: assessed by a semi-structured interview.
Effectiveness: MiniAsthma Quality of Life Questionnaire, MiniAQLQ
Time frame: Through study completion, an average of 1 year
Patient-related outcome, disease specific quality of life questionnaire. 7-point Likert scales from 1-7, 1 = worse outcome, 7 = better outcome. Success rates of improvements minus deteriorations of individual effects, measured at 12 month follow up.
4 secondary outcomes
MiniAsthma Quality of Life Questionnaire, MiniAQLQ
Time frame: Change from baseline to 12 months
Breathing pattern observation
Time frame: Change from baseline to 12 month
Objective physical activity level
Time frame: Change from baseline to 12 month
Objective steps per day (average)
Time frame: Change from baseline to 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren T Skou, Prof. study chair
Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark
Lars H Tang, Assoc.Prof. study chair
Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark
Cecilie L Egholm, PostDoc. study chair
Naestved-Slagelse-Ringsted Hospitals, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Retraining in people with Asthma, run by Naestved Hospital at 1 site in Denmark.
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 4 inclusion and 2 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 2 Jul 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 Denmark. 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?
Adoption of intervention (Uptake) (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.