Dysfunctional Breathing in AsthmaBEAT_DBNCT03127059
Breathing Exercises in Asthma Targeting Dysfunctional Breathing
A study testing Breathing Exercises in people with Dysfunctional Breathing in Asthma, run by Naestved Hospital at 8 sites in Denmark.
Trial summary
Dyspnoe can disable patients with asthma. Dysfunctional breathing (DB), resulting in dyspnoe, can mimic or exaggerate asthma. Around every forth patient with asthma have DB. Breathing exercises (BrEX) can improve asthma-related quality of live (QOL) in less severe asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysfunctional Breathing in Asthma
- What is being tested?
- Breathing Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 8 sitesDenmark
- Study dates
- 27 Apr 2017to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Referred from GP to a secondary, out-patient respiratory clinic for lack of asthma control
- Pulmonologist-diagnosed asthma
- ≥ 2 consultations at a pulmonologist-lead asthma clinic
- ACQ6 ≥0.8
- Able to provide written informed consent.
Who cannot join
- Trained in breathing exercises by physiotherapist last 6 months
- Aged <18
- Pregnancy
- Not able to speak, read or understand Danish
- Any severe disease as judged by the responsible physician
- Participating in another pulmonary interventional research-project.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Denmark8 sites
Dep. of Physiotherapy and Dep. of Pulmonology
Aalborg, Region North
Dep. of Physiotherapy and Dep. of Pulmonology
Bispebjerg, Danish Capital Region
Allergi og Lungeklinikken Helsingør
Elsinore, Danish Capital Region, 3000
Dep. of Physiotherapy and Dep. of Pulmonology
Hvidovre, Danish Capital Region
Dep. of Physiotherapy and Dep. of Pulmonology
Næstved, Region Sjælland
Dep. of Physiotherapy and Dep. of Pulmonology
Odense, Region Syddanmark, 5000
Dep. of Physiotherapy and Dep. of Pulmonology
Roskilde, Region Sjælland
Dep. of Physiotherapy and Dep. of Pulmonology
Silkeborg, Central Jutland, 8600
About this study
Official title: BEAT DB-study; Breathing Exercises in Asthma Targeting Dysfunctional Breathing-a Randomised Controlled Trial
Dyspnoe can disable patients with asthma. Dysfunctional breathing (DB), resulting in dyspnoe, can mimic or exaggerate asthma. Around every forth patient with asthma have DB. Breathing exercises (BrEX) can improve asthma-related quality of live (QOL) in less severe asthma. No study has investigated the effect of BrEX on QOL neither on level of physical activity in severe asthma.
A randomised controlled multicentre trial will include 190 adults with poor asthma control (Asthma Control Questionnaire (ACQ6)-score≥0.8) from seven outpatient departments and one specialized private clinic. Patients will be allocated to either usual care (no intervention) or breathing exercises (BrEX)-treatment consisting of 12-week intervention including three physiotherapist-sessions focusing on breathing pattern modification (Papworth Method; Buteyko technique) in rest and activity and 10 minutes home-exercise twice daily. Primary outcome is change in Mini Asthma Quality of Life Questionnaire (MiniAQLQ) at six-months follow-up.
Read the detailed description
In Denmark around 300,000 suffer from asthma. Dyspnoe can disable patients with asthma. Dysfunctional breathing (DB), resulting in dyspnoe, can mimic or exaggerate asthma. Around 20-29% of asthmatic patients have DB. Breathing exercises (BrEX) can improve asthma-related quality of life (QOL) and control of asthma symptoms in less severe asthma. No study has investigated the effect of BrEX on QOL neither on level of physical activity in severe asthma.
A randomised controlled multicentre trial will include 190 adults with poor asthma control (Asthma Control Questionnaire (ACQ6)-score≥0.8) from seven outpatient departments and one specialized private clinic. After optimizing of inhalation technique, patients will be allocated to either usual care (no intervention) or BrEX-treatment consisting of 12-week intervention including three physiotherapist-sessions focusing on breathing pattern modification (Papworth Method; Buteyko technique) in rest and activity and 10 minutes home-exercise twice daily. Primary outcome is change in Mini Asthma Quality of Life Questionnaire (MiniAQLQ) at six-months follow-up. Secondary outcomes are changes in ACQ6, Nijmegen Hyperventilation Questionnaire (NQ), Hospital Anxiety and Depression Scale (HAD), accelerometry (physical activity level, number of steps), 6 minutes walk distance, and forced expiratory volume in first second (FEV1), besides response of Global perceived effect rate (GPE) in asthma-related QOL and asthma control.
- Conditions
- Dysfunctional Breathing in Asthma
- Being tested
- Breathing Exercises, Usual care
- Keywords
- Dysfunctional Breathing, Uncontrolled Asthma, Breathing Exercises, Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing ExercisesOther
Also called BrEX
Key points in the intervention are
- Reduction (or normalising) of the respiration rate; use of rhythmic, nasal inspiration, diaphragmatic breathing; reduction of depth of breath, longer expiration; breath-holding at functional residual capacity.
- Relaxation, especially the neck, jaw, tongue, and shoulders. Emphasizing the impact of gravity to the body.
- Inclusion of the breathing modification into walking and other physical activities.
- Daily home exercise of BrEX.
Usual careOther
Also called UC
Participants will receive only short information given initially at recruitment. No instruction or booklet will be distributed in the Usual care-Group.
| Study group | Role | What they receive |
|---|---|---|
| Breathing Exercises | Experimental | Individual instruction from a nurse at baseline aimed at knowledge on pharmacological treatment and optimized inhalation techniques. The participants will be encouraged to use online video instruction.
Three physiotherapist-sessions of Breathing Exercises (BrEX) with duration of 60 minutes (the initial) and 30 minutes (other sessions) at week 1, 4, and 9. The participant is expected to do 10 minutes of home exercise twice daily. The entire intervention combines elements of the Papworth method, and the Buteyko technique. Receives: Other: Breathing Exercises |
| Usual care | Other | Individual instruction from a nurse at baseline aimed at knowledge on pharmacological treatment and optimized inhalation techniques. The participants will be encouraged to use online video instruction.
Besides the individual instruction described above, patients will receive only short information given initially at recruitment. They are allowed to receive instruction in positive expiratory pressure-treatment and physiotherapy targeting other problems than dysfunctional breathing (DB). Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
MiniAQLQ is a disease-specific patient-reported outcome on experiences during the previous two weeks. The original version of AQLQ (32 items) is recommended for clinical use, whereas this shortened version is suggested for research. In moderate to severe asthma cohorts, MiniAQLQ has good reliability (ICC 0.83-0.86) and strong validity (criteria validity to AQLQ, r≥0.80; construct validity against ACQ, r=0.69). MiniAQLQ has 15 items in four domains (symptoms, activity limitation, emotions, environment), which are answered using a 7-point Likert scale (1=maximum impairment; 7=no impairment).
Measured: Primary endpoint: Change from baseline to 6 months follow up. Secondary endpoints will be 3 and 12 months follow up.
Secondary outcomes (7)
Asthma Control Questionnaire (ACQ6)
Asthma Control Questionnaire (ACQ6) will be used in the 6 sub-score version omitting FEV1 % of predicted. The outcome-score is the mean of 6 sub-scores (5 questions about symptoms, 1 question in use of reliever medication (beta2-agonist)) using a 7-point Likert scale (0=fully controlled; 6=severely uncontrolled)
Measured: Change from baseline to 3, 6, and 12 months follow up
Nijmegen Questionnaire (NQ)
A Nijmegen Questionnaire (NQ)-score > 23 suggests symptomatic hyperventilation, but is typically used to define DB.
Measured: Change from baseline to 3, 6, and 12 months follow up
Hospital Anxiety and Depression Scale (HAD)
Hospital Anxiety and Depression Scale (HAD) uses a 0-21 scale; a low score indicates least mental health problems.
Measured: Change from baseline to 3, 6, and 12 months follow up
Global perceived effect rate (GPE)
Global perceived effect rate (GPE) will be used as a retrospective evaluation of effect in asthma-related QOL as well as in asthma control on a 7-point Likert scale. GPE will only be measured at the follow ups.
Measured: At 3, 6, and 12 months follow up
Accelerometry (PAL, number of steps)
Physical activity level (PAL) and numbers of steps will be measured by an accelerometer (BodyMedia SenseWear®) monitoring during 5 days
Measured: Change from baseline to 3 and 6 months follow up.
Spirometry (FEV1)
Spirometry (MedikroPro) will be used to measure forced expiratory volume in first second in liter (FEV1).
Measured: Change from baseline to 6 months follow up.
6 Minutes Walk Distance (6MWD)
6 Minutes Walk Distance (6MWD); 6MWD is the most typically used function-score in pulmonary research.
Measured: Change from baseline to 6 months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start27 Apr 2017
- Primary completion14 Apr 2020
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dysfunctional Breathing in 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-centre, assessor-blinded, 2-arm randomised controlled trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital, Hvidovre University Hospital, Aalborg University Hospital, Bispebjerg Hospital, TrygFonden, Denmark, Slagelse Hospital, Region Zealand, Association of Danish Physiotherapists, Allergi og Lungeklinikken Helsingør, Regionshospitalet Silkeborg, Odense University Hospital
- Responsible party
- Principal investigator, Karen Hjerrild Andreasson, Naestved Hospital
- Investigators
- Karen H Andreasson, PT MSc, Principal investigator, University of Southern Denmark, Dep. of Physiotherapy and Occupational Therapy, Neastved-Slagelse-Ringsted Hospitals, Region Zealand, DenmarkUffe Bødtger, MD PhD, Study chair, University of Southern Denmark and Naestved HospitalSøren T Skou, PT PhD, Study chair, University of Southern Denmark and Naestved-Slagelse-Ringsted HospitalsMike Thomas, Prof MD PhD, Study chair, University of Southampton and Aldermoor Health Centre, SouthamptonCeleste Porsbjerg, Prof MD PhD, Study chair, University of Copenhagen and Bispebjerg HospitalCharlotte S Ulrik, Prof MD PhD, Study chair, University of Copenhagen and Hvidovre HospitalPeder G Fabricius, MD, Study chair, Universityhospital RoskildeKarin D Assing, MD, Study chair, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127059
- Sponsor's protocol ID
- SJ-552
- Acronym
- BEAT_DB
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2017
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Andreasson KH, Skou ST, Ulrik CS, Madsen H, Sidenius K, Jacobsen JS, Assing KD, Rasmussen KB, Porsbjerg C, Thomas M, Bodtger U. Protocol for a multicentre randomised controlled trial to investigate the effect on asthma-related quality of life from breathing retraining in patients with incomplete asthma control attending specialist care in Denmark. BMJ Open. 2019 Dec 31;9(12):e032984. doi: 10.1136/bmjopen-2019-032984.
PubMed 31892661Andreasson KH, Skou ST, Ulrik CS, Madsen H, Sidenius K, Assing KD, Porsbjerg C, Bloch-Nielsen J, Thomas M, Bodtger U. Breathing Exercises for Patients with Asthma in Specialist Care: A Multicenter Randomized Clinical Trial. Ann Am Thorac Soc. 2022 Sep;19(9):1498-1506. doi: 10.1513/AnnalsATS.202111-1228OC.
PubMed 35588357
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEAT DB-study; Breathing Exercises in Asthma Targeting Dysfunctional Breathing-a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03127059
- Acronym / sponsor ID
- BEAT_DB / SJ-552
- Conditions
- Dysfunctional Breathing in Asthma
- Keywords
- Dysfunctional Breathing, Uncontrolled Asthma, Breathing Exercises, Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Collaborators
- Zealand University Hospital, Hvidovre University Hospital, Aalborg University Hospital, Bispebjerg Hospital, TrygFonden, Denmark, Slagelse Hospital, Region Zealand, Association of Danish Physiotherapists, Allergi og Lungeklinikken Helsingør, Regionshospitalet Silkeborg, Odense University Hospital
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 14 Apr 2020 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 25 Apr 2017 (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.
Dyspnoe can disable patients with asthma. Dysfunctional breathing (DB), resulting in dyspnoe, can mimic or exaggerate asthma. Around every forth patient with asthma have DB. Breathing exercises (BrEX) can improve asthma-related quality of live (QOL) in less severe asthma. No study has investigated the effect of BrEX on QOL neither on level of physical activity in severe asthma.
A randomised controlled multicentre trial will include 190 adults with poor asthma control (Asthma Control Questionnaire (ACQ6)-score≥0.8) from seven outpatient departments and one specialized private clinic. Patients will be allocated to either usual care (no intervention) or breathing exercises (BrEX)-treatment consisting of 12-week intervention including three physiotherapist-sessions focusing on breathing pattern modification (Papworth Method; Buteyko technique) in rest and activity and 10 minutes home-exercise twice daily. Primary outcome is change in Mini Asthma Quality of Life Questionnaire (MiniAQLQ) at six-months follow-up.
Detailed description
In Denmark around 300,000 suffer from asthma. Dyspnoe can disable patients with asthma. Dysfunctional breathing (DB), resulting in dyspnoe, can mimic or exaggerate asthma. Around 20-29% of asthmatic patients have DB. Breathing exercises (BrEX) can improve asthma-related quality of life (QOL) and control of asthma symptoms in less severe asthma. No study has investigated the effect of BrEX on QOL neither on level of physical activity in severe asthma.
A randomised controlled multicentre trial will include 190 adults with poor asthma control (Asthma Control Questionnaire (ACQ6)-score≥0.8) from seven outpatient departments and one specialized private clinic. After optimizing of inhalation technique, patients will be allocated to either usual care (no intervention) or BrEX-treatment consisting of 12-week intervention including three physiotherapist-sessions focusing on breathing pattern modification (Papworth Method; Buteyko technique) in rest and activity and 10 minutes home-exercise twice daily. Primary outcome is change in Mini Asthma Quality of Life Questionnaire (MiniAQLQ) at six-months follow-up. Secondary outcomes are changes in ACQ6, Nijmegen Hyperventilation Questionnaire (NQ), Hospital Anxiety and Depression Scale (HAD), accelerometry (physical activity level, number of steps), 6 minutes walk distance, and forced expiratory volume in first second (FEV1), besides response of Global perceived effect rate (GPE) in asthma-related QOL and asthma control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-centre, assessor-blinded, 2-arm randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercises | Experimental | Other: Breathing ExercisesIndividual instruction from a nurse at baseline aimed at knowledge on pharmacological treatment and optimized inhalation techniques. The participants will be encouraged to use online video instruction. Three physiotherapist-sessions of Breathing Exercises (BrEX) with duration of 60 minutes (the initial) and 30 minutes (other sessions) at week 1, 4, and 9. The participant is expected to do 10 minutes of home exercise twice daily. The entire intervention combines elements of the Papworth method, and the Buteyko technique. |
| Usual care | Other | Other: Usual careIndividual instruction from a nurse at baseline aimed at knowledge on pharmacological treatment and optimized inhalation techniques. The participants will be encouraged to use online video instruction. Besides the individual instruction described above, patients will receive only short information given initially at recruitment. They are allowed to receive instruction in positive expiratory pressure-treatment and physiotherapy targeting other problems than dysfunctional breathing (DB). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Referred from GP to a secondary, out-patient respiratory clinic for lack of asthma control
- Pulmonologist-diagnosed asthma
- ≥ 2 consultations at a pulmonologist-lead asthma clinic
- ACQ6 ≥0.8
- Able to provide written informed consent.
Key exclusion criteria (6 listed)
- Trained in breathing exercises by physiotherapist last 6 months
- Aged <18
- Pregnancy
- Not able to speak, read or understand Danish
- Any severe disease as judged by the responsible physician
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 ExercisesAlso: BrEXKey points in the intervention are * Reduction (or normalising) of the respiration rate; use of rhythmic, nasal inspiration, diaphragmatic breathing; reduction of depth of breath, longer expiration; breath-holding at functional residual capacity. * Relaxation, especially the neck, jaw, tongue, and shoulders. Emphasizing the impact of gravity to the body. * Inclusion of the breathing modification into walking and other physical activities. * Daily home exercise of BrEX. | Other | Breathing Exercises |
| Usual careAlso: UCParticipants will receive only short information given initially at recruitment. No instruction or booklet will be distributed in the Usual care-Group. | Other | Usual care |
Primary outcome
Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
Time frame: Primary endpoint: Change from baseline to 6 months follow up. Secondary endpoints will be 3 and 12 months follow up.
MiniAQLQ is a disease-specific patient-reported outcome on experiences during the previous two weeks. The original version of AQLQ (32 items) is recommended for clinical use, whereas this shortened version is suggested for research. In moderate to severe asthma cohorts, MiniAQLQ has good reliability (ICC 0.83-0.86) and strong validity (criteria validity to AQLQ, r≥0.80; construct validity against ACQ, r=0.69). MiniAQLQ has 15 items in four domains (symptoms, activity limitation, emotions, environment), which are answered using a 7-point Likert scale (1=maximum impairment; 7=no impairment).
7 secondary outcomes
Asthma Control Questionnaire (ACQ6)
Time frame: Change from baseline to 3, 6, and 12 months follow up
Nijmegen Questionnaire (NQ)
Time frame: Change from baseline to 3, 6, and 12 months follow up
Hospital Anxiety and Depression Scale (HAD)
Time frame: Change from baseline to 3, 6, and 12 months follow up
Global perceived effect rate (GPE)
Time frame: At 3, 6, and 12 months follow up
Accelerometry (PAL, number of steps)
Time frame: Change from baseline to 3 and 6 months follow up.
Spirometry (FEV1)
Time frame: Change from baseline to 6 months follow up.
6 Minutes Walk Distance (6MWD)
Time frame: Change from baseline to 6 months follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 31892661Andreasson KH, Skou ST, Ulrik CS, Madsen H, Sidenius K, Jacobsen JS, Assing KD, Rasmussen KB, Porsbjerg C, Thomas M, Bodtger U. Protocol for a multicentre randomised controlled trial to investigate the effect on asthma-related quality of life from breathing retraining in patients with incomplete asthma control attending specialist care in Denmark. BMJ Open. 2019 Dec 31;9(12):e032984. doi: 10.1136/bmjopen-2019-032984.
- Results publication: PubMed 35588357Andreasson KH, Skou ST, Ulrik CS, Madsen H, Sidenius K, Assing KD, Porsbjerg C, Bloch-Nielsen J, Thomas M, Bodtger U. Breathing Exercises for Patients with Asthma in Specialist Care: A Multicenter Randomized Clinical Trial. Ann Am Thorac Soc. 2022 Sep;19(9):1498-1506. doi: 10.1513/AnnalsATS.202111-1228OC.
- Individual participant dataSharing planned: Undecided
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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.
Karen H Andreasson, PT MSc principal investigator
University of Southern Denmark, Dep. of Physiotherapy and Occupational Therapy, Neastved-Slagelse-Ringsted Hospitals, Region Zealand, Denmark
Uffe Bødtger, MD PhD study chair
University of Southern Denmark and Naestved Hospital
Søren T Skou, PT PhD study chair
University of Southern Denmark and Naestved-Slagelse-Ringsted Hospitals
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Exercises in people with Dysfunctional Breathing in Asthma, run by Naestved Hospital at 8 sites 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mini Asthma Quality of Life Questionnaire (MiniAQLQ) (time frame: Primary endpoint: Change from baseline to 6 months follow up. Secondary endpoints will be 3 and 12 months follow up.). 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 NCT03127059, which also lists 2 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 Jun 2026.