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

Not Applicable

Active, not recruiting

• Conditions: Asthma
• Interventions: Other: Breathing Retraining

• Registration Number: NCT05531370
• Lead Sponsor: Naestved Hospital

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.

Study Timeline

• Study Start: 2022-06-30
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-09-03
• Study First Posted: 2022-09-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breathing Retraining (BR)	Breathing Retraining	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Naestved Hospital; 🇩🇰 Naestved, Region Zealand, Denmark