An interventional study of Breathing Retraining in Asthma, sponsored by Naestved Hospital. Active, not recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Naestved Hospital · Not applicable, Interventional, and Other
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.
Exclusion Criteria:
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
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.
Also known as: Breathing Exercises
Adoption of intervention (Uptake)
Organization-related (Pulmonologists, general practioners, physiotherapists) outcome: Proportion of general practices and of hospitals that will adopt BR.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 1 year
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to 12 month
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.
Time frame: Change from baseline to 12 month
Adverse events (Safety)
Patient-related outcome; number, % caused discontinuation.
Time frame: 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.
Time frame: Change from baseline to 12 month
Number of online sessions delivered
Number, % of total sessions.
Time frame: Post-intervention (3-month)
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Naestved Hospital