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Completed

NCT Number: NCT03127059

Breathing Exercises in Asthma Targeting Dysfunctional Breathing

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.

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Key information

Conditions

Dysfunctional Breathing in Asthma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dep. of Physiotherapy and Dep. of Pulmonology, Silkeborg, Central Jutland, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: BrEX

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.

Other names: UC

Primary outcomes

  1. Mini Asthma Quality of Life Questionnaire (MiniAQLQ)

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

    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).

Secondary outcomes

  1. Asthma Control Questionnaire (ACQ6)

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

    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)

  2. Nijmegen Questionnaire (NQ)

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

    A Nijmegen Questionnaire (NQ)-score > 23 suggests symptomatic hyperventilation, but is typically used to define DB.

  3. Hospital Anxiety and Depression Scale (HAD)

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

    Hospital Anxiety and Depression Scale (HAD) uses a 0-21 scale; a low score indicates least mental health problems.

  4. Global perceived effect rate (GPE)

    Time frame: At 3, 6, and 12 months follow up

    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.

  5. Accelerometry (PAL, number of steps)

    Time frame: Change from baseline to 3 and 6 months follow up.

    Physical activity level (PAL) and numbers of steps will be measured by an accelerometer (BodyMedia SenseWear®) monitoring during 5 days

  6. Spirometry (FEV1)

    Time frame: Change from baseline to 6 months follow up.

    Spirometry (MedikroPro) will be used to measure forced expiratory volume in first second in liter (FEV1).

  7. 6 Minutes Walk Distance (6MWD)

    Time frame: Change from baseline to 6 months follow up.

    6 Minutes Walk Distance (6MWD); 6MWD is the most typically used function-score in pulmonary research.

Other outcomes

  1. Accelerometry (METs, TEE)

    Time frame: Change from baseline to 3 and 6 months follow up.

    Average metabolic equivalents (METs) and Total energy expenditure (TEE) will be measured by an accelerometer (BodyMedia SenseWear®) monitoring during 5 days.

  2. Spirometry (FVC, PEF)

    Time frame: Change from baseline to 6 months follow up.

    Spirometry (MedikroPro) will be used to measure forced vital capacity (FVC), units liter, and peak expiratory flow rate (PEF), units liter/minute.

  3. Inspiratory muscle strength (MIP)

    Time frame: Change from baseline to 6 months follow up.

    Inspiratory muscle strength (MIP), units cmH2O, will be measured by POWER Breathe®, KH2.

  4. Adverse events (AE)

    Time frame: 12 months before baseline until 12 months follow-up.

    Adverse events (AE) e.g. emergency room visits will be extracted from medical report and from EasyTrial.Net (research database)

  5. Register data from medical report

    Time frame: 12 months before baseline until 12 months follow-up.

    Comorbidity (types and numbers) and number of consultations at nurse and/or pulmonologist.

  6. Register of Medical Product Statistics

    Time frame: 12 months before baseline until 12 months follow-up.

    For precise measure extraction of prescriptions on anti-asthmatic medication and comorbid medication on ATC-codes.

  7. Foster Score

    Time frame: Change from inhalationcheck (before baseline) to 6 months follow up.

    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.

  8. Adherence to physiotherapy-sessions

    Time frame: At 12 months follow-up.

    Adherence to the physiotherapist-sessions during the 12 weeks intervention will be investigated though data extracted in the electronically medical records.

  9. Patient Acceptable Symptom State (PASS)

    Time frame: At 3, 6, and 12 months follow up.

    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.

  10. Participant-reported treatment failure.

    Time frame: At 3, 6, and 12 months follow up.

    If the participant answers 'no' to Patient Acceptable Symptom State (PASS) he/she will be asked to consider whether the treatment has failed.

  11. Breath Holding Time (BHT)

    Time frame: Change from baseline to 6 months follow up.

    Time in seconds when nose is pinched at functional residual capasity until first respiratory muscle movement.

  12. Count Scale (CS)

    Time frame: Change from baseline to 6 months follow up.

    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.

  13. Borg CR10

    Time frame: Change from baseline to 6 months follow up.

    Dyspnoe will be measured before and after 6MWD by the Borg CR10.

  14. EuroQual-5Dimension (EQ-5D)

    Time frame: Change from baseline to 3, 6, and 12 months follow up.

    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.

  15. Socio Economic Status (SES)

    Time frame: Only assessed at baseline.

    Socio Economic Status (SES) includes education, work status, income.

  16. Gender, Body Mass Index, smoking status, age

    Time frame: Only assessed at baseline.

    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.

Sponsors and collaborators

Lead sponsor

Naestved Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: BEAT_DB

Important dates

Study start
2017
Primary completion
2020
Study completion
2026
First posted
Apr 25, 2017
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.