Breathing Exercises in Asthma Targeting Dysfunctional Breathing

NCT03127059 | Active Not Recruiting

• 1 other identifier: SJ-552
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

Dysfunctional Breathing; Uncontrolled Asthma; Breathing Exercises; Adults

Outcome Measures

Primary Outcomes (1)

• Mini Asthma Quality of Life Questionnaire (MiniAQLQ)

  MiniAQLQ is a disease-specific patient-reported outcome on experiences during the previous two weeks. The original version of AQLQ (32 items) is recommended for clinical use, whereas this shortened version is suggested for research. In moderate to severe asthma cohorts, MiniAQLQ has good reliability (ICC 0.83-0.86) and strong validity (criteria validity to AQLQ, r≥0.80; construct validity against ACQ, r=0.69). MiniAQLQ has 15 items in four domains (symptoms, activity limitation, emotions, environment), which are answered using a 7-point Likert scale (1=maximum impairment; 7=no impairment).

  Primary endpoint: Change from baseline to 6 months follow up. Secondary endpoints will be 3 and 12 months follow up.

Secondary Outcomes (7)

• Asthma Control Questionnaire (ACQ6)

  Change from baseline to 3, 6, and 12 months follow up

• Nijmegen Questionnaire (NQ)

  Change from baseline to 3, 6, and 12 months follow up

• Hospital Anxiety and Depression Scale (HAD)

  Change from baseline to 3, 6, and 12 months follow up

• Global perceived effect rate (GPE)

  At 3, 6, and 12 months follow up

• Accelerometry (PAL, number of steps)

  Change from baseline to 3 and 6 months follow up.

Other Outcomes (16)

• Accelerometry (METs, TEE)

  Change from baseline to 3 and 6 months follow up.

• Spirometry (FVC, PEF)

  Change from baseline to 6 months follow up.

• Inspiratory muscle strength (MIP)

  Change from baseline to 6 months follow up.

Study Arms (2)

Breathing Exercises

EXPERIMENTAL

Individual instruction from a nurse at baseline aimed at knowledge on pharmacological treatment and optimized inhalation techniques. The participants will be encouraged to use online video instruction. Three physiotherapist-sessions of Breathing Exercises (BrEX) with duration of 60 minutes (the initial) and 30 minutes (other sessions) at week 1, 4, and 9. The participant is expected to do 10 minutes of home exercise twice daily. The entire intervention combines elements of the Papworth method, and the Buteyko technique.

Other: Breathing Exercises

Usual care

OTHER

Individual instruction from a nurse at baseline aimed at knowledge on pharmacological treatment and optimized inhalation techniques. The participants will be encouraged to use online video instruction. Besides the individual instruction described above, patients will receive only short information given initially at recruitment. They are allowed to receive instruction in positive expiratory pressure-treatment and physiotherapy targeting other problems than dysfunctional breathing (DB).

Other: Usual care

Interventions

Breathing Exercises OTHER

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.

Also known as: BrEX

Breathing Exercises

Usual care OTHER

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

Also known as: UC

Usual care

Eligibility Criteria

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

You may qualify if:

• Referred from GP to a secondary, out-patient respiratory clinic for lack of asthma control
• Pulmonologist-diagnosed asthma
• ≥ 2 consultations at a pulmonologist-lead asthma clinic
• ACQ6 ≥0.8
• Able to provide written informed consent.

You may not qualify if:

• Trained in breathing exercises by physiotherapist last 6 months
• Aged \<18
• Pregnancy
• Not able to speak, read or understand Danish
• Any severe disease as judged by the responsible physician
• Participating in another pulmonary interventional research-project.

Sponsors & Collaborators

• Naestved Hospital: lead
• Zealand University Hospital: collaborator
• Hvidovre University Hospital: collaborator
• Aalborg University Hospital: collaborator
• Bispebjerg Hospital: collaborator
• TrygFonden, Denmark: collaborator
• Slagelse Hospital: collaborator
• Region Zealand: collaborator
• Association of Danish Physiotherapists: collaborator
• Allergi og Lungeklinikken Helsingør: collaborator
• Regionshospitalet Silkeborg: collaborator
• Odense University Hospital: collaborator

Study Sites (8)

Dep. of Physiotherapy and Dep. of Pulmonology

Silkeborg, Central Jutland, 8600, Denmark

Location

Dep. of Physiotherapy and Dep. of Pulmonology

Bispebjerg, Danish Capital Region, Denmark

Location

Allergi og Lungeklinikken Helsingør

Elsinore, Danish Capital Region, 3000, Denmark

Location

Dep. of Physiotherapy and Dep. of Pulmonology

Hvidovre, Danish Capital Region, Denmark

Location

Dep. of Physiotherapy and Dep. of Pulmonology

Aalborg, Region North, Denmark

Location

Dep. of Physiotherapy and Dep. of Pulmonology

Næstved, Region Sjælland, Denmark

Location

Dep. of Physiotherapy and Dep. of Pulmonology

Roskilde, Region Sjælland, Denmark

Location

Dep. of Physiotherapy and Dep. of Pulmonology

Odense, Region Syddanmark, 5000, Denmark

Location

Related Publications (2)

• Andreasson KH, Skou ST, Ulrik CS, Madsen H, Sidenius K, Jacobsen JS, Assing KD, Rasmussen KB, Porsbjerg C, Thomas M, Bodtger U. Protocol for a multicentre randomised controlled trial to investigate the effect on asthma-related quality of life from breathing retraining in patients with incomplete asthma control attending specialist care in Denmark. BMJ Open. 2019 Dec 31;9(12):e032984. doi: 10.1136/bmjopen-2019-032984.

  PMID: 31892661 BACKGROUND

• Andreasson KH, Skou ST, Ulrik CS, Madsen H, Sidenius K, Assing KD, Porsbjerg C, Bloch-Nielsen J, Thomas M, Bodtger U. Breathing Exercises for Patients with Asthma in Specialist Care: A Multicenter Randomized Clinical Trial. Ann Am Thorac Soc. 2022 Sep;19(9):1498-1506. doi: 10.1513/AnnalsATS.202111-1228OC.

  PMID: 35588357 RESULT

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

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

Study Officials

• Karen H Andreasson, PT MSc

  University of Southern Denmark, Dep. of Physiotherapy and Occupational Therapy, Neastved-Slagelse-Ringsted Hospitals, Region Zealand, Denmark

  PRINCIPAL INVESTIGATOR

• Uffe Bødtger, MD PhD

  University of Southern Denmark and Naestved Hospital

  STUDY CHAIR

• Søren T Skou, PT PhD

  University of Southern Denmark and Naestved-Slagelse-Ringsted Hospitals

  STUDY CHAIR

• Mike Thomas, Prof MD PhD

  University of Southampton and Aldermoor Health Centre, Southampton

  STUDY CHAIR

• Celeste Porsbjerg, Prof MD PhD

  University of Copenhagen and Bispebjerg Hospital

  STUDY CHAIR

• Charlotte S Ulrik, Prof MD PhD

  University of Copenhagen and Hvidovre Hospital

  STUDY CHAIR

• Peder G Fabricius, MD

  Universityhospital Roskilde

  STUDY CHAIR

• Karin D Assing, MD

  Aalborg University Hospital

  STUDY CHAIR

• Kirsten E Sidenius, MD PhD

  Allergi og Lungeklinikken Helsingør

  STUDY CHAIR

• Charlotte Hyldgaard, MD

  Diagnostisk Center, Regionshospitalet Silkeborg

  STUDY CHAIR

• Hanne Madsen, MD PhD

  University of Southern Denmark and Odense University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Three assessors (physiotherapists) will perform the objective assessment of capacity and lung parameters. Nurses in the outpatient departments will obtain data from medical records. The assessors and the nurses will be blinded for the allocation. The primary invenstigator will have no access to the data during the period of datacollection. Primary and most of the secondary outcomes will be patient-reported.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.-Student, PT

Model Details: Multi-centre, assessor-blinded, 2-arm randomised controlled trial.

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 25, 2017
• Study Start: April 27, 2017
• Primary Completion: April 14, 2020
• Study Completion: August 31, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

DK (8)