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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breathing Retraining (BR) | Experimental | 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathing Retraining | Other | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ashma severity by Global Initiative for Asthma (GINA) treatment steps | Patient-related outcome. Asthma severity assessed by pharmacotherapy level, calculated into GINA treatment steps 1-5 (1 = mild asthma, 5 = severe asthma), using a questionnaire completed by the physiotherapist during an interview with the patient. | Change from baseline to 12 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Søren T Skou, Prof. | Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark | Study Chair |
| Lars H Tang, Assoc.Prof. | Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark | Study Chair |
| Cecilie L Egholm, PostDoc. | Naestved-Slagelse-Ringsted Hospitals, Denmark | Study Chair |
| Uffe Bodtger, Prof. | Zealand University Hospital; University of Southern Denmark | Study Chair |
| Mike Thomas, Prof. | Primary Care Research University of Southampton, UK | Study Chair |
| Karen H Andreasson, Dr. | Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naestved Hospital | Næstved | Region Sjælland | 4700 | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 1, 2024 | Jun 6, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 19, 2026 | Jun 25, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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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 |
| Adverse events (Safety) | Patient-related outcome; number, % caused discontinuation. | Post-intervention (3-month) |
| Asthma Control Questionnaire, ACQ5 | Patient-related outcome: ACQ5 i.e. item 1-5 of the ACQ. Mean of asthma symptom level questionnaire; 7-point Likert scales from 0-6, 0 = better outcome, 6 = worse outcome. | Change from baseline to 12 month |
| Number of online sessions delivered | Number, % of total sessions. | Post-intervention (3-month) |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D026741 |
| Physical Therapy Modalities |