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NCT Number: NCT05531370

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naestved Hospital

Næstved, Region Sjælland, 4700, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

breathing retraining

Other

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

Primary outcomes

  1. Adoption of intervention (Uptake)

    Time frame: 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.

  2. Implementation of intervention (Fidelity)

    Time frame: 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.

  3. Feasibility of online sessions in Hybrid delivery mode of BR (H-BR) (Acceptability)

    Time frame: Through study completion, an average of 1 year

    Patient- and Organization-related (physiotherapists) outcome: assessed by a semi-structured interview.

  4. Effectiveness: MiniAsthma Quality of Life Questionnaire, MiniAQLQ

    Time frame: 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 outcomes

  1. MiniAsthma Quality of Life Questionnaire, MiniAQLQ

    Time frame: 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.

  2. Breathing pattern observation

    Time frame: Change from baseline to 12 month

    Patient-related outcome. Pre-defined key aspects of the breathing pattern assessed qualitatively observation by the physiotherapist.

  3. Objective physical activity level

    Time frame: 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.

  4. Objective steps per day (average)

    Time frame: 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.

Other outcomes

  1. Ashma severity by Global Initiative for Asthma (GINA) treatment steps

    Time frame: Change from baseline to 12 month

    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.

  2. Adverse events (Safety)

    Time frame: Post-intervention (3-month)

    Patient-related outcome; number, % caused discontinuation.

  3. Asthma Control Questionnaire, ACQ5

    Time frame: Change from baseline to 12 month

    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.

  4. Number of online sessions delivered

    Time frame: Post-intervention (3-month)

    Number, % of total sessions.

Sponsors and collaborators

Lead sponsor

Naestved Hospital

Other

Registry information

Official study title

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

Acronym: EmBRAiZ

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Sep 7, 2022
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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