Breathing Exercises in Asthma Targeting Dysfunctional Breathing
NCT ID: NCT03127059
Last Updated: 2024-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
190 participants
INTERVENTIONAL
2017-04-27
2024-08-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
The primary invenstigator will have no access to the data during the period of datacollection.
Primary and most of the secondary outcomes will be patient-reported.
Study Groups
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Breathing Exercises
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.
Breathing Exercises
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 care
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).
Usual care
Participants will receive only short information given initially at recruitment. No instruction or booklet will be distributed in the Usual care-Group.
Interventions
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Breathing Exercises
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 care
Participants will receive only short information given initially at recruitment. No instruction or booklet will be distributed in the Usual care-Group.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pulmonologist-diagnosed asthma
* ≥ 2 consultations at a pulmonologist-lead asthma clinic
* ACQ6 ≥0.8
* Able to provide written informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Zealand University Hospital
OTHER
Hvidovre University Hospital
OTHER
Aalborg University Hospital
OTHER
Bispebjerg Hospital
OTHER
TrygFonden, Denmark
INDUSTRY
Slagelse Hospital
OTHER
Region Zealand
OTHER
Association of Danish Physiotherapists
OTHER
Allergi og Lungeklinikken Helsingør
UNKNOWN
Regionshospitalet Silkeborg
OTHER
Odense University Hospital
OTHER
Naestved Hospital
OTHER
Responsible Party
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Karen Hjerrild Andreasson
Ph.D.-Student, PT
Principal Investigators
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Karen H Andreasson, PT MSc
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark, Dep. of Physiotherapy and Occupational Therapy, Neastved-Slagelse-Ringsted Hospitals, Region Zealand, Denmark
Uffe Bødtger, MD PhD
Role: STUDY_CHAIR
University of Southern Denmark and Naestved Hospital
Søren T Skou, PT PhD
Role: STUDY_CHAIR
University of Southern Denmark and Naestved-Slagelse-Ringsted Hospitals
Mike Thomas, Prof MD PhD
Role: STUDY_CHAIR
University of Southampton and Aldermoor Health Centre, Southampton
Celeste Porsbjerg, Prof MD PhD
Role: STUDY_CHAIR
University of Copenhagen and Bispebjerg Hospital
Charlotte S Ulrik, Prof MD PhD
Role: STUDY_CHAIR
University of Copenhagen and Hvidovre Hospital
Peder G Fabricius, MD
Role: STUDY_CHAIR
Universityhospital Roskilde
Karin D Assing, MD
Role: STUDY_CHAIR
Aalborg University Hospital
Kirsten E Sidenius, MD PhD
Role: STUDY_CHAIR
Allergi og Lungeklinikken Helsingør
Charlotte Hyldgaard, MD
Role: STUDY_CHAIR
Diagnostisk Center, Regionshospitalet Silkeborg
Hanne Madsen, MD PhD
Role: STUDY_CHAIR
University of Southern Denmark and Odense University Hospital
Locations
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Dep. of Physiotherapy and Dep. of Pulmonology
Silkeborg, Central Jutland, Denmark
Dep. of Physiotherapy and Dep. of Pulmonology
Bispebjerg, Danish Capital Region, Denmark
Allergi og Lungeklinikken Helsingør
Elsinore, Danish Capital Region, Denmark
Dep. of Physiotherapy and Dep. of Pulmonology
Hvidovre, Danish Capital Region, Denmark
Dep. of Physiotherapy and Dep. of Pulmonology
Aalborg, Region North, Denmark
Dep. of Physiotherapy and Dep. of Pulmonology
Næstved, Region Sjælland, Denmark
Dep. of Physiotherapy and Dep. of Pulmonology
Roskilde, Region Sjælland, Denmark
Dep. of Physiotherapy and Dep. of Pulmonology
Odense, Region Syddanmark, Denmark
Countries
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References
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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.
Andreasson 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.
Other Identifiers
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SJ-552
Identifier Type: -
Identifier Source: org_study_id
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