Implementation of Evidence-based Breathing Retraining for Patients With Asthma in Region Zealand

Study Overview
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Brief Summary
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This study aims to implement the evidence-based intervention breathing retraining into clinical care of patients with symptomatic asthma irrespective of asthma severity or comorbidities, and in a diverse multicentre setting to evaluate implementation outcomes. This will meet patients' needs and improve health and life situation in patients with uncontrolled asthma. Further, the study will evaluate implementation outcomes.

Detailed Description
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This study is a hybrid-designed prospective multicenter implementation evaluation study, in which the investigators secondarily will maintain measuring effectiveness of breathing retraining in a real-world setting including primary and secondary health care and add cross-sectorial co-operation. Thus, investigators include more primary outcomes. The study is part of Exercise First-project, a collaboration of The National Health Service, Region Zealand and the research unit PROgrez, Department of Physiotherapy and Occupational Therapy at Næstved, Slagelse, Ringsted hospitals.

Official Title
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Implementation of Evidence-based Breathing Retraining for Patients With Asthma in Region Zealand, Denmark

Conditions
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Asthma

Intervention / Treatment
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* Other: Breathing Retraining


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Doctor diagnosed asthma; Incompletely controlled asthma or worse: Asthma Control Questionnaire (ACQ5) score ≥0.8; Residence (or asthma treatment program) in Region Zealand, Denmark; Able to read and understand Danish or available assistance to help understand information material, intervention content and respond to questionnaires. Exclusion Criteria: Unwilling to participate; Unable to participate in the intervention due to physical or mental condition.

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breathing Retraining (BR)<br>Patients will receive three sessions (60 min, 30 min, 30 min) of breathing retraining (BR), 1-to-1 with a trained physiotherapist. As preferred by the patient: Hybrid delivery mode of BR (H-BR): First session on-site at hospital/clinic for initial assessment and introduction, and following sessions online (MedComs VDX platform or equal; participants access using web cam and sound on smart phone, tablet, or pc). Ordinary delivery of BR: Three sessions on-site at hospital/clinic. | Other: Breathing Retraining<br>* Conforming the real-world setting, all participants will continue standard asthma care, i.e., acute and planned visits at GP or pulmonologist. BR aims to normalize the inhaled volume, nasal inhalation, exhalation to the resting position of the chest (functional residual capacity, FRC), use of the diaphragm muscle, and to move lower parts of the chest in a frequency of 12-16 per minute. This pattern is initially trained in rest (e.g., side lying or sitting), then during physical activity (e.g., walking). Uncontrolled coughing, frequent yawning or sighing is handled by a suppression technique. Relaxation technique is introduced as a separate activity but to be combined with the breathing pattern method to be used in both resting and as possible during physical activity.<br>* Other names: Breathing Exercises;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adoption of intervention (Uptake) | Organization-related (Pulmonologists, general practioners, physiotherapists) outcome: Proportion of general practices and of hospitals that will adopt BR. | Through study completion, an average of 1 year | 
| Implementation of intervention (Fidelity) | Organization-related (physiotherapists) outcome: % of contents delivered as planned assessed by a checklist of key aspects in the breathing retraining-intervention. | Through study completion, an average of 1 year | 
| Feasibility of online sessions in Hybrid delivery mode of BR (H-BR) (Acceptability) | Patient- and Organization-related (physiotherapists) outcome: assessed by a semi-structured interview. | Through study completion, an average of 1 year | 
| Effectiveness: MiniAsthma Quality of Life Questionnaire, MiniAQLQ | Patient-related outcome, disease specific quality of life questionnaire. 7-point Likert scales from 1-7, 1 = worse outcome, 7 = better outcome. Success rates of improvements minus deteriorations of individual effects, measured at 12 month follow up. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MiniAsthma Quality of Life Questionnaire, MiniAQLQ | Patient-related outcome: Mean of disease specific quality of life questionnaire. 7-point Likert scales from 1-7, 1 = worse outcome, 7 = better outcome. | Change from baseline to 12 months | 
| Breathing pattern observation | Patient-related outcome. Pre-defined key aspects of the breathing pattern assessed qualitatively observation by the physiotherapist. | Change from baseline to 12 month | 
| Objective physical activity level | Patient-related outcome. Objectively measured physical activity and inactivity using combined wearable thigh and wrist accelerometers, worn for seven consecutive days. | Change from baseline to 12 month | 
| Objective steps per day (average) | Patient-related outcome. Objectively measured steps per day using combined wearable thigh and wrist accelerometers, worn for seven consecutive days. | Change from baseline to 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implementation, Asthma, Breathing Retraining