Clinical trial NCT03127059: Breathing Exercises in Asthma Targeting Dysfunctional Breathing
Official title: BEAT DB-study; Breathing Exercises in Asthma Targeting Dysfunctional Breathing-a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dysfunctional Breathing in Asthma
Keywords: Dysfunctional Breathing
Uncontrolled Asthma
Breathing Exercises
Adults
Lead sponsor: Naestved Hospital
Sponsor class: OTHER
Collaborators: name: Zealand University Hospital
name: Hvidovre University Hospital
name: Aalborg University Hospital
name: Bispebjerg Hospital
name: TrygFonden, Denmark
name: Slagelse Hospital
name: Region Zealand
name: Association of Danish Physiotherapists
name: Allergi og Lungeklinikken Helsingør
name: Regionshospitalet Silkeborg
name: Odense University Hospital
First posted: 2017-04-25
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-centre, assessor-blinded, 2-arm randomised controlled trial.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
timeFrame: Primary endpoint: Change from baseline to 6 months follow up. Secondary endpoints will be 3 and 12 months follow up.
Secondary outcomes:
measure: Asthma Control Questionnaire (ACQ6)
timeFrame: Change from baseline to 3, 6, and 12 months follow up
measure: Nijmegen Questionnaire (NQ)
timeFrame: Change from baseline to 3, 6, and 12 months follow up
measure: Hospital Anxiety and Depression Scale (HAD)
timeFrame: Change from baseline to 3, 6, and 12 months follow up
measure: Global perceived effect rate (GPE)
timeFrame: At 3, 6, and 12 months follow up
measure: Accelerometry (PAL, number of steps)
timeFrame: Change from baseline to 3 and 6 months follow up.
measure: Spirometry (FEV1)
timeFrame: Change from baseline to 6 months follow up.
measure: 6 Minutes Walk Distance (6MWD)
timeFrame: Change from baseline to 6 months follow up.
Other outcomes:
measure: Accelerometry (METs, TEE)
timeFrame: Change from baseline to 3 and 6 months follow up.
measure: Spirometry (FVC, PEF)
timeFrame: Change from baseline to 6 months follow up.
measure: Inspiratory muscle strength (MIP)
timeFrame: Change from baseline to 6 months follow up.
measure: Adverse events (AE)
timeFrame: 12 months before baseline until 12 months follow-up.
measure: Register data from medical report
timeFrame: 12 months before baseline until 12 months follow-up.
measure: Register of Medical Product Statistics
timeFrame: 12 months before baseline until 12 months follow-up.
measure: Foster Score
timeFrame: Change from inhalationcheck (before baseline) to 6 months follow up.
measure: Adherence to physiotherapy-sessions
timeFrame: At 12 months follow-up.
measure: Patient Acceptable Symptom State (PASS)
timeFrame: At 3, 6, and 12 months follow up.
measure: Participant-reported treatment failure.
timeFrame: At 3, 6, and 12 months follow up.
measure: Breath Holding Time (BHT)
timeFrame: Change from baseline to 6 months follow up.
measure: Count Scale (CS)
timeFrame: Change from baseline to 6 months follow up.
measure: Borg CR10
timeFrame: Change from baseline to 6 months follow up.
measure: EuroQual-5Dimension (EQ-5D)
timeFrame: Change from baseline to 3, 6, and 12 months follow up.
measure: Socio Economic Status (SES)
timeFrame: Only assessed at baseline.
measure: Gender, Body Mass Index, smoking status, age
timeFrame: Only assessed at baseline.
Locations:
city: Silkeborg
country: Denmark
facility: Dep. of Physiotherapy and Dep. of Pulmonology
state: Central Denmark Region
city: Bispebjerg
country: Denmark
facility: Dep. of Physiotherapy and Dep. of Pulmonology
state: Danish Capital Region
city: Helsingør
country: Denmark
facility: Allergi og Lungeklinikken Helsingør
state: Danish Capital Region
city: Hvidovre
country: Denmark
facility: Dep. of Physiotherapy and Dep. of Pulmonology
state: Danish Capital Region
city: Aalborg
country: Denmark
facility: Dep. of Physiotherapy and Dep. of Pulmonology
state: Region North
city: Odense
country: Denmark
facility: Dep. of Physiotherapy and Dep. of Pulmonology
state: Region Of Southern Denmark
city: Naestved
country: Denmark
facility: Dep. of Physiotherapy and Dep. of Pulmonology
state: Region Zealand
city: Roskilde
country: Denmark
facility: Dep. of Physiotherapy and Dep. of Pulmonology
state: Region Zealand
Study officials:
affiliation: University of Southern Denmark, Dep. of Physiotherapy and Occupational Therapy, Neastved-Slagelse-Ringsted Hospitals, Region Zealand, Denmark
name: Karen H Andreasson, PT MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Denmark and Naestved Hospital
name: Uffe Bødtger, MD PhD
role: STUDY_CHAIR
affiliation: University of Southern Denmark and Naestved-Slagelse-Ringsted Hospitals
name: Søren T Skou, PT PhD
role: STUDY_CHAIR
affiliation: University of Southampton and Aldermoor Health Centre, Southampton
name: Mike Thomas, Prof MD PhD
role: STUDY_CHAIR
affiliation: University of Copenhagen and Bispebjerg Hospital
name: Celeste Porsbjerg, Prof MD PhD
role: STUDY_CHAIR
affiliation: University of Copenhagen and Hvidovre Hospital
name: Charlotte S Ulrik, Prof MD PhD
role: STUDY_CHAIR
affiliation: Universityhospital Roskilde
name: Peder G Fabricius, MD
role: STUDY_CHAIR
affiliation: Aalborg University Hospital
name: Karin D Assing, MD
role: STUDY_CHAIR
affiliation: Allergi og Lungeklinikken Helsingør
name: Kirsten E Sidenius, MD PhD
role: STUDY_CHAIR
affiliation: Diagnostisk Center, Regionshospitalet Silkeborg
name: Charlotte Hyldgaard, MD
role: STUDY_CHAIR
affiliation: University of Southern Denmark and Odense University Hospital
name: Hanne Madsen, MD PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.