Breathing Exercises in Asthma Targeting Dysfunctional Breathing

NCT03127059 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2024-03-22

No results posted yet for this study

Summary

Dyspnoe can disable patients with asthma. Dysfunctional breathing (DB), resulting in dyspnoe, can mimic or exaggerate asthma. Around every forth patient with asthma have DB. Breathing exercises (BrEX) can improve asthma-related quality of live (QOL) in less severe asthma. No study has investigated the effect of BrEX on QOL neither on level of physical activity in severe asthma.

A randomised controlled multicentre trial will include 190 adults with poor asthma control (Asthma Control Questionnaire (ACQ6)-score≥0.8) from seven outpatient departments and one specialized private clinic. Patients will be allocated to either usual care (no intervention) or breathing exercises (BrEX)-treatment consisting of 12-week intervention including three physiotherapist-sessions focusing on breathing pattern modification (Papworth Method; Buteyko technique) in rest and activity and 10 minutes home-exercise twice daily. Primary outcome is change in Mini Asthma Quality of Life Questionnaire (MiniAQLQ) at six-months follow-up.

Conditions

  • Dysfunctional Breathing in Asthma

Interventions

OTHER

Breathing Exercises

Key points in the intervention are * Reduction (or normalising) of the respiration rate; use of rhythmic, nasal inspiration, diaphragmatic breathing; reduction of depth of breath, longer expiration; breath-holding at functional residual capacity. * Relaxation, especially the neck, jaw, tongue, and shoulders. Emphasizing the impact of gravity to the body. * Inclusion of the breathing modification into walking and other physical activities. * Daily home exercise of BrEX.

OTHER

Usual care

Participants will receive only short information given initially at recruitment. No instruction or booklet will be distributed in the Usual care-Group.

Sponsors & Collaborators

  • Zealand University Hospital

    collaborator OTHER
  • Hvidovre University Hospital

    collaborator OTHER
  • Aalborg University Hospital

    collaborator OTHER
  • Bispebjerg Hospital

    collaborator OTHER
  • TrygFonden, Denmark

    collaborator INDUSTRY
  • Slagelse Hospital

    collaborator OTHER
  • Region Zealand

    collaborator OTHER
  • Association of Danish Physiotherapists

    collaborator OTHER
  • Allergi og Lungeklinikken Helsingør

    collaborator UNKNOWN
  • Regionshospitalet Silkeborg

    collaborator OTHER
  • Odense University Hospital

    collaborator OTHER
  • Naestved Hospital

    lead OTHER

Principal Investigators

  • Karen H Andreasson, PT MSc · University of Southern Denmark, Dep. of Physiotherapy and Occupational Therapy, Neastved-Slagelse-Ringsted Hospitals, Region Zealand, Denmark

  • Uffe Bødtger, MD PhD · University of Southern Denmark and Naestved Hospital

  • Søren T Skou, PT PhD · University of Southern Denmark and Naestved-Slagelse-Ringsted Hospitals

  • Mike Thomas, Prof MD PhD · University of Southampton and Aldermoor Health Centre, Southampton

  • Celeste Porsbjerg, Prof MD PhD · University of Copenhagen and Bispebjerg Hospital

  • Charlotte S Ulrik, Prof MD PhD · University of Copenhagen and Hvidovre Hospital

  • Peder G Fabricius, MD · Universityhospital Roskilde

  • Karin D Assing, MD · Aalborg University Hospital

  • Kirsten E Sidenius, MD PhD · Allergi og Lungeklinikken Helsingør

  • Charlotte Hyldgaard, MD · Diagnostisk Center, Regionshospitalet Silkeborg

  • Hanne Madsen, MD PhD · University of Southern Denmark and Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-27
Primary Completion
2020-04-14
Completion
2024-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03127059 on ClinicalTrials.gov