Dysfunctional Breathing in Asthma
Conditions
Keywords
Dysfunctional Breathing, Uncontrolled Asthma, Breathing Exercises, Adults
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.
Interventions
OTHERBreathing 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.
OTHERUsual care
Participants will receive only short information given initially at recruitment. No instruction or booklet will be distributed in the Usual care-Group.
Sponsors
Naestved Hospital
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 design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Three assessors (physiotherapists) will perform the objective assessment of capacity and lung parameters. Nurses in the outpatient departments will obtain data from medical records. The assessors and the nurses will be blinded for the allocation. 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.
Intervention model description
Multi-centre, assessor-blinded, 2-arm randomised controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mini Asthma Quality of Life Questionnaire (MiniAQLQ) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Questionnaire (ACQ6) | Change from baseline to 3, 6, and 12 months follow up | 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) |
| Nijmegen Questionnaire (NQ) | Change from baseline to 3, 6, and 12 months follow up | A Nijmegen Questionnaire (NQ)-score \> 23 suggests symptomatic hyperventilation, but is typically used to define DB. |
| Hospital Anxiety and Depression Scale (HAD) | Change from baseline to 3, 6, and 12 months follow up | Hospital Anxiety and Depression Scale (HAD) uses a 0-21 scale; a low score indicates least mental health problems. |
| Global perceived effect rate (GPE) | At 3, 6, and 12 months follow up | 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. |
| Accelerometry (PAL, number of steps) | Change from baseline to 3 and 6 months follow up. | Physical activity level (PAL) and numbers of steps will be measured by an accelerometer (BodyMedia SenseWear®) monitoring during 5 days |
| Spirometry (FEV1) | Change from baseline to 6 months follow up. | Spirometry (MedikroPro) will be used to measure forced expiratory volume in first second in liter (FEV1). |
| 6 Minutes Walk Distance (6MWD) | Change from baseline to 6 months follow up. | 6 Minutes Walk Distance (6MWD); 6MWD is the most typically used function-score in pulmonary research. |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORKaren H Andreasson, PT MSc
University of Southern Denmark, Dep. of Physiotherapy and Occupational Therapy, Neastved-Slagelse-Ringsted Hospitals, Region Zealand, Denmark
STUDY_CHAIRUffe Bødtger, MD PhD
University of Southern Denmark and Naestved Hospital
STUDY_CHAIRSøren T Skou, PT PhD
University of Southern Denmark and Naestved-Slagelse-Ringsted Hospitals
STUDY_CHAIRMike Thomas, Prof MD PhD
University of Southampton and Aldermoor Health Centre, Southampton
STUDY_CHAIRCeleste Porsbjerg, Prof MD PhD
University of Copenhagen and Bispebjerg Hospital
STUDY_CHAIRCharlotte S Ulrik, Prof MD PhD
University of Copenhagen and Hvidovre Hospital
STUDY_CHAIRPeder G Fabricius, MD
Universityhospital Roskilde
STUDY_CHAIRKarin D Assing, MD
Aalborg University Hospital
STUDY_CHAIRKirsten E Sidenius, MD PhD
Allergi og Lungeklinikken Helsingør
STUDY_CHAIRCharlotte Hyldgaard, MD
Diagnostisk Center, Regionshospitalet Silkeborg
STUDY_CHAIRHanne Madsen, MD PhD
University of Southern Denmark and Odense University Hospital
Outcome results
None listed