Breathing Exercises in Asthma Targeting Dysfunctional Breathing

Study Overview
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Brief Summary
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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
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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.

Official Title
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BEAT DB-study; Breathing Exercises in Asthma Targeting Dysfunctional Breathing-a Randomised Controlled Trial

Conditions
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Dysfunctional Breathing in Asthma

Intervention / Treatment
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* Other: Breathing Exercises
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multi-centre, assessor-blinded, 2-arm randomised controlled trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breathing Exercises<br>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. | Other: Breathing Exercises<br>* 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.<br>* Other names: BrEX;|
| Other: Usual care<br>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). | Other: Usual care<br>* Participants will receive only short information given initially at recruitment. No instruction or booklet will be distributed in the Usual care-Group.<br>* Other names: UC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Primary endpoint: Change from baseline to 6 months follow up. Secondary endpoints will be 3 and 12 months follow up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | 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. | 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. | 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 | 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). | 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. | Change from baseline to 6 months follow up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysfunctional Breathing, Uncontrolled Asthma, Breathing Exercises, Adults