Asthma
Conditions
Keywords
Implementation, Asthma, Breathing Retraining
Brief summary
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
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.
Interventions
OTHERBreathing 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.
Sponsors
Naestved Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adoption of intervention (Uptake) | Through study completion, an average of 1 year | Organization-related (Pulmonologists, general practioners, physiotherapists) outcome: Proportion of general practices and of hospitals that will adopt BR. |
| Implementation of intervention (Fidelity) | Through study completion, an average of 1 year | Organization-related (physiotherapists) outcome: % of contents delivered as planned assessed by a checklist of key aspects in the breathing retraining-intervention. |
| Feasibility of online sessions in Hybrid delivery mode of BR (H-BR) (Acceptability) | Through study completion, an average of 1 year | Patient- and Organization-related (physiotherapists) outcome: assessed by a semi-structured interview. |
| Effectiveness: MiniAsthma Quality of Life Questionnaire, MiniAQLQ | Through study completion, an average of 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MiniAsthma Quality of Life Questionnaire, MiniAQLQ | Change from baseline to 12 months | Patient-related outcome: Mean of disease specific quality of life questionnaire. 7-point Likert scales from 1-7, 1 = worse outcome, 7 = better outcome. |
| Breathing pattern observation | Change from baseline to 12 month | Patient-related outcome. Pre-defined key aspects of the breathing pattern assessed qualitatively observation by the physiotherapist. |
| Objective physical activity level | Change from baseline to 12 month | Patient-related outcome. Objectively measured physical activity and inactivity using combined wearable thigh and wrist accelerometers, worn for seven consecutive days. |
| Objective steps per day (average) | Change from baseline to 12 month | Patient-related outcome. Objectively measured steps per day using combined wearable thigh and wrist accelerometers, worn for seven consecutive days. |
Countries
Denmark
Contacts
STUDY_CHAIRSøren T Skou, Prof.
Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark
STUDY_CHAIRLars H Tang, Assoc.Prof.
Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark
STUDY_CHAIRCecilie L Egholm, PostDoc.
Naestved-Slagelse-Ringsted Hospitals, Denmark
STUDY_CHAIRUffe Bodtger, Prof.
Zealand University Hospital; University of Southern Denmark
STUDY_CHAIRMike Thomas, Prof.
Primary Care Research University of Southampton, UK
PRINCIPAL_INVESTIGATORKaren H Andreasson, Dr.
Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark
Outcome results
None listed