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

NCT05531370 | Active Not Recruiting

• 1 other identifier: EMN-2022-01229
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Implementation; Asthma; Breathing Retraining

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• MiniAsthma Quality of Life Questionnaire, MiniAQLQ

  Change from baseline to 12 months

• Breathing pattern observation

  Change from baseline to 12 month

• Objective physical activity level

  Change from baseline to 12 month

• Objective steps per day (average)

  Change from baseline to 12 month

Other Outcomes (4)

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

  Change from baseline to 12 month

• Adverse events (Safety)

  Post-intervention (3-month)

• Asthma Control Questionnaire, ACQ5

  Change from baseline to 12 month

Study Arms (1)

Breathing Retraining (BR)

EXPERIMENTAL

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

Interventions

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.

Also known as: Breathing Exercises

Breathing Retraining (BR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unwilling to participate;
• Unable to participate in the intervention due to physical or mental condition.

Sponsors & Collaborators

• Naestved Hospital: lead

Study Sites (1)

Naestved Hospital

Næstved, Region Sjælland, 4700, Denmark

Location

MeSH Terms

Conditions

Asthma

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• 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

  STUDY CHAIR

• Karen H Andreasson, Dr.

  Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: September 7, 2022
• Study Start: June 30, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

DK (1)