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

Asthma Clinical Trial

— EmBRAiZ  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05531370
• Other study ID #: EMN-2022-01229
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: Naestved Hospital
• Contact: Karen H Andreasson, Dr.
• Phone: +45 24254926
• Email: khad[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
Denmark	Naestved Hospital	Naestved	Region Zealand

Sponsors (1)

Lead Sponsor	Collaborator
Naestved Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Adverse events (Safety)	Patient-related outcome; number, % caused discontinuation.	Post-intervention (3-month)
Other	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
Other	Number of online sessions delivered	Number, % of total sessions.	Post-intervention (3-month)
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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