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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Other: Breathing Retraining

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Region Zealand
    • Naestved, Region Zealand, Denmark, 4700
      • Naestved Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Breathing Retraining (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; 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.; Other Names: Breathing Exercises

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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
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)

Collaborators and Investigators

• Sponsor: Naestved Hospital
• Investigators: Study Chair: 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; Principal Investigator: Karen H Andreasson, Dr., Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: September 3, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Implementation; Asthma; Breathing Retraining
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: EMN-2022-01229

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No