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Breathing Exercises in Asthma Targeting Dysfunctional Breathing (BEAT_DB)

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ClinicalTrials.gov Identifier: NCT03127059
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : January 11, 2019
Sponsor:
Collaborators:
Zealand University Hospital
Hvidovre University Hospital
Aalborg Universitetshospital
Bispebjerg Hospital
TrygFonden, Denmark
Slagelse Hospital
Region Zealand
Association of Danish Physiotherapists
Allergi og Lungeklinikken Helsingør
Regionshospitalet Silkeborg
Odense University Hospital
Information provided by (Responsible Party):
Karen Hjerrild Andreasson, Naestved Hospital

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 220 adults with poor asthma control (Asthma Control Questionnaire (ACQ6)-score≥1.5) from five outpatient departments. 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.


Condition or disease Intervention/treatment Phase
Dysfunctional Breathing in Asthma Other: Breathing Exercises Other: Usual care Not Applicable

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 220 adults with poor asthma control (Asthma Control Questionnaire (ACQ6)-score≥1.5) from five outpatient departments. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-centre, assessor-blinded, 2-arm randomised controlled trial.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: BEAT DB-study; Breathing Exercises in Asthma Targeting Dysfunctional Breathing—a Randomised Controlled Trial
Actual Study Start Date : April 27, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


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 Name: BrEX

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 Name: UC




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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. 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.

  12. Borg CR10 [ Time Frame: Change from baseline to 6 months follow up. ]
    Dyspnoe will be measured before and after 6MWD by the Borg CR10.

  13. 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.

  14. Socio Economic Status (SES) [ Time Frame: Only assessed at baseline. ]
    Socio Economic Status (SES) includes education, work status, income.

  15. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pulmonologist-diagnosed asthma
  • ≥ 2 consultations at pulmonologist previously
  • ACQ6 ≥1.5
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127059


Contacts
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Contact: Karen H Andreasson, PT MSc +45 24 25 49 26 khad@regionsjaelland.dk
Contact: Uffe Bødtger, MD PhD +45 56 51 45 92 ubt@regionsjaelland.dk

Locations
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Denmark
Dep. of Physiotherapy and Dep. of Pulmonology Recruiting
Silkeborg, Central Denmark Region, Denmark, 8600
Contact: Karen H Andreasson       khad@regionsjaelland.dk   
Dep. of Physiotherapy and Dep. of Pulmonology Recruiting
Bispebjerg, Danish Capital Region, Denmark
Contact: Karen H Andreasson       khad@regionsjaelland.dk   
Allergi og Lungeklinikken Helsingør Recruiting
Helsingør, Danish Capital Region, Denmark, 3000
Contact: Karen H Andreasson       khad@regionsjaelland.dk   
Dep. of Physiotherapy and Dep. of Pulmonology Recruiting
Hvidovre, Danish Capital Region, Denmark
Contact: Karen H Andreasson       khad@regionsjaelland.dk   
Dep. of Physiotherapy and Dep. of Pulmonology Recruiting
Aalborg, Region North, Denmark
Contact: Karen H Andreasson       khad@regionsjaelland.dk   
Dep. of Physiotherapy and Dep. of Pulmonology Recruiting
Odense, Region Of Southern Denmark, Denmark, 5000
Contact: Karen H Andreasson       khad@regionsjaelland.dk   
Dep. of Physiotherapy and Dep. of Pulmonology Recruiting
Naestved, Region Zealand, Denmark
Contact: Karen H Andreasson, PT MSc    +45 24 25 49 26    khad@regionsjaelland.dk   
Contact: Uffe Bødtger, MD PhD    +45 56 51 45 92    ubt@regionsjaelland.dk   
Dep. of Physiotherapy and Dep. of Pulmonology Recruiting
Roskilde, Region Zealand, Denmark
Contact: Karen H Andreasson       khad@regionsjaelland.dk   
Sponsors and Collaborators
Naestved Hospital
Zealand University Hospital
Hvidovre University Hospital
Aalborg Universitetshospital
Bispebjerg Hospital
TrygFonden, Denmark
Slagelse Hospital
Region Zealand
Association of Danish Physiotherapists
Allergi og Lungeklinikken Helsingør
Regionshospitalet Silkeborg
Odense University Hospital
Investigators
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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 Universitetshospital
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

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Responsible Party: Karen Hjerrild Andreasson, Ph.D.-Student, PT, Naestved Hospital
ClinicalTrials.gov Identifier: NCT03127059     History of Changes
Other Study ID Numbers: SJ-552
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karen Hjerrild Andreasson, Naestved Hospital:
Dysfunctional Breathing
Uncontrolled Asthma
Breathing Exercises
Adults

Additional relevant MeSH terms:
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Asthma
Respiratory Aspiration
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Pathologic Processes