Breathing Exercises in Asthma Targeting Dysfunctional Breathing (BEAT_DB)

BEAT DB-study; Breathing Exercises in Asthma Targeting Dysfunctional Breathing-a Randomised Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dysfunctional Breathing in Asthma
• Intervention / Treatment: Other: Breathing Exercises; Other: Usual care

Detailed Description

In Denmark around 300,000 suffer from asthma. Dyspnoe can disable patients with asthma. Dysfunctional breathing (DB), resulting in dyspnoe, can mimic or exaggerate asthma. Around 20-29% of asthmatic patients have DB. Breathing exercises (BrEX) can improve asthma-related quality of life (QOL) and control of asthma symptoms 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. After optimizing of inhalation technique, patients will be allocated to either usual care (no intervention) or 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. Secondary outcomes are changes in ACQ6, Nijmegen Hyperventilation Questionnaire (NQ), Hospital Anxiety and Depression Scale (HAD), accelerometry (physical activity level, number of steps), 6 minutes walk distance, and forced expiratory volume in first second (FEV1), besides response of Global perceived effect rate (GPE) in asthma-related QOL and asthma control.

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Central Denmark Region
    • Silkeborg, Central Denmark Region, Denmark, 8600
      • Dep. of Physiotherapy and Dep. of Pulmonology
  • Danish Capital Region
    • Bispebjerg, Danish Capital Region, Denmark
      • Dep. of Physiotherapy and Dep. of Pulmonology
    • Helsingør, Danish Capital Region, Denmark, 3000
      • Allergi og Lungeklinikken Helsingør
    • Hvidovre, Danish Capital Region, Denmark
      • Dep. of Physiotherapy and Dep. of Pulmonology
  • Region North
    • Aalborg, Region North, Denmark
      • Dep. of Physiotherapy and Dep. of Pulmonology
  • Region Of Southern Denmark
    • Odense, Region Of Southern Denmark, Denmark, 5000
      • Dep. of Physiotherapy and Dep. of Pulmonology
  • Region Zealand
    • Naestved, Region Zealand, Denmark
      • Dep. of Physiotherapy and Dep. of Pulmonology
    • Roskilde, Region Zealand, Denmark
      • Dep. of Physiotherapy and Dep. of Pulmonology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breathing Exercises; 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; 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 Names: BrEX
Other: Usual care; 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; Participants will receive only short information given initially at recruitment. No instruction or booklet will be distributed in the Usual care-Group.; Other Names: UC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Control Questionnaire (ACQ6)	Asthma Control Questionnaire (ACQ6) will be used in the 6 sub-score version omitting FEV1 % of predicted. The outcome-score is the mean of 6 sub-scores (5 questions about symptoms, 1 question in use of reliever medication (beta2-agonist)) using a 7-point Likert scale (0=fully controlled; 6=severely uncontrolled)	Change from baseline to 3, 6, and 12 months follow up
Nijmegen Questionnaire (NQ)	A Nijmegen Questionnaire (NQ)-score > 23 suggests symptomatic hyperventilation, but is typically used to define DB.	Change from baseline to 3, 6, and 12 months follow up
Hospital Anxiety and Depression Scale (HAD)	Hospital Anxiety and Depression Scale (HAD) uses a 0-21 scale; a low score indicates least mental health problems.	Change from baseline to 3, 6, and 12 months follow up
Global perceived effect rate (GPE)	Global perceived effect rate (GPE) will be used as a retrospective evaluation of effect in asthma-related QOL as well as in asthma control on a 7-point Likert scale. GPE will only be measured at the follow ups.	At 3, 6, and 12 months follow up
Accelerometry (PAL, number of steps)	Physical activity level (PAL) and numbers of steps will be measured by an accelerometer (BodyMedia SenseWear®) monitoring during 5 days	Change from baseline to 3 and 6 months follow up.
Spirometry (FEV1)	Spirometry (MedikroPro) will be used to measure forced expiratory volume in first second in liter (FEV1).	Change from baseline to 6 months follow up.
6 Minutes Walk Distance (6MWD)	6 Minutes Walk Distance (6MWD); 6MWD is the most typically used function-score in pulmonary research.	Change from baseline to 6 months follow up.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accelerometry (METs, TEE)	Average metabolic equivalents (METs) and Total energy expenditure (TEE) will be measured by an accelerometer (BodyMedia SenseWear®) monitoring during 5 days.	Change from baseline to 3 and 6 months follow up.
Spirometry (FVC, PEF)	Spirometry (MedikroPro) will be used to measure forced vital capacity (FVC), units liter, and peak expiratory flow rate (PEF), units liter/minute.	Change from baseline to 6 months follow up.
Inspiratory muscle strength (MIP)	Inspiratory muscle strength (MIP), units cmH2O, will be measured by POWER Breathe®, KH2.	Change from baseline to 6 months follow up.
Adverse events (AE)	Adverse events (AE) e.g. emergency room visits will be extracted from medical report and from EasyTrial.Net (research database)	12 months before baseline until 12 months follow-up.
Register data from medical report	Comorbidity (types and numbers) and number of consultations at nurse and/or pulmonologist.	12 months before baseline until 12 months follow-up.
Register of Medical Product Statistics	For precise measure extraction of prescriptions on anti-asthmatic medication and comorbid medication on ATC-codes.	12 months before baseline until 12 months follow-up.
Foster Score	Foster Score is used to investigate the number of days during the last seven days the participant took his/her asthma medication as prescribed. The participant is interviewed at the inhalationcheck, and will answer 0 to 7 referring to the number of days. Assessed again at 6 months follow up by questionnaire.	Change from inhalationcheck (before baseline) to 6 months follow up.
Adherence to physiotherapy-sessions	Adherence to the physiotherapist-sessions during the 12 weeks intervention will be investigated though data extracted in the electronically medical records.	At 12 months follow-up.
Patient Acceptable Symptom State (PASS)	The dichotomous Patient Acceptable Symptom State (PASS) evaluates treatment success in the patient's perspective. The PASS will only be measured at the follow ups.	At 3, 6, and 12 months follow up.
Participant-reported treatment failure.	If the participant answers 'no' to Patient Acceptable Symptom State (PASS) he/she will be asked to consider whether the treatment has failed.	At 3, 6, and 12 months follow up.
Breath Holding Time (BHT)	Time in seconds when nose is pinched at functional residual capasity until first respiratory muscle movement.	Change from baseline to 6 months follow up.
Count Scale (CS)	Count Scale (CS) includes the count scale number (starting from 1 counting to as high as possible) and time spent while counting at a constant speed of 2 counts per second during one exhalation from max inspiratory level. CS has lower coefficient of variance at lower exercise level, than Borg Scale.	Change from baseline to 6 months follow up.
Borg CR10	Dyspnoe will be measured before and after 6MWD by the Borg CR10.	Change from baseline to 6 months follow up.
EuroQual-5Dimension (EQ-5D)	EuroQual-5Dimension (EQ-5D), a generic QOL tool that has high responsiveness, is translated into Danish and cross-cultural validated. EQ-5D index score of has been derived in the Danish population.	Change from baseline to 3, 6, and 12 months follow up.
Socio Economic Status (SES)	Socio Economic Status (SES) includes education, work status, income.	Only assessed at baseline.
Gender, Body Mass Index, smoking status, age	Participants gender, Body Mass Index (e.g., weight and height will be combined to report BMI in kg/m^2), smoking status (smoker/ former smoker/ non-smoker), and age will be self-reported at baseline.	Only assessed at baseline.

Collaborators and Investigators

• Sponsor: Naestved Hospital
• Collaborators: Odense University Hospital; Zealand University Hospital; Hvidovre University Hospital; Bispebjerg Hospital; TrygFonden, Denmark; Aalborg University Hospital; Slagelse Hospital; Association of Danish Physiotherapists; Region Zealand; Regionshospitalet Silkeborg; Allergi og Lungeklinikken Helsingør
• Investigators: Principal Investigator: Karen H Andreasson, PT MSc, University of Southern Denmark, Dep. of Physiotherapy and Occupational Therapy, Neastved-Slagelse-Ringsted Hospitals, Region Zealand, Denmark; Study Chair: 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2017
• Primary Completion (Actual): April 14, 2020
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Adults; Uncontrolled Asthma; Breathing Exercises; Dysfunctional Breathing
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Respiratory Aspiration; Asthma
• Other Study ID Numbers: SJ-552

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No