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

NCT ID: NCT05531370

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2025-12-31

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.

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Breathing Retraining

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Breathing Exercises

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Naestved Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Søren T Skou, Prof.

Role: STUDY_CHAIR

Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark

Lars H Tang, Assoc.Prof.

Role: STUDY_CHAIR

Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark

Cecilie L Egholm, PostDoc.

Role: STUDY_CHAIR

Naestved-Slagelse-Ringsted Hospitals, Denmark

Uffe Bodtger, Prof.

Role: STUDY_CHAIR

Zealand University Hospital; University of Southern Denmark

Mike Thomas, Prof.

Role: STUDY_CHAIR

Primary Care Research University of Southampton, UK

Karen H Andreasson, Dr.

Role: PRINCIPAL_INVESTIGATOR

Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark

Locations

Naestved Hospital

Næstved, Region Sjælland, Denmark

Countries

Denmark

Other Identifiers

EMN-2022-01229

Identifier Type: -

Identifier Source: org_study_id