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| Name | Class |
|---|---|
| Zealand University Hospital | OTHER |
| Hvidovre University Hospital | OTHER |
| Aalborg University Hospital | OTHER |
| Bispebjerg Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathing Exercises | Other | Key points in the intervention are
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| 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. |
| 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 |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Physiotherapy and Dep. of Pulmonology | Silkeborg | Central Jutland | 8600 | Denmark | ||
| Dep. of Physiotherapy and Dep. of Pulmonology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31892661 | Background | 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. | |
| 35588357 |
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| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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| OTHER |
| TrygFonden, Denmark | INDUSTRY |
| Slagelse Hospital | OTHER |
| Region Zealand | OTHER |
| Association of Danish Physiotherapists | OTHER |
| Allergi og Lungeklinikken Helsingør | UNKNOWN |
| Regionshospitalet Silkeborg | OTHER |
| Odense University Hospital | OTHER |
Multi-centre, assessor-blinded, 2-arm randomised controlled trial.
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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.
|
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| 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. |
|
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| 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. |
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. |
| 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 |
| Bispebjerg |
| Danish Capital Region |
| Denmark |
| Allergi og Lungeklinikken Helsingør | Elsinore | Danish Capital Region | 3000 | Denmark |
| Dep. of Physiotherapy and Dep. of Pulmonology | Hvidovre | Danish Capital Region | Denmark |
| Dep. of Physiotherapy and Dep. of Pulmonology | Aalborg | Region North | Denmark |
| Dep. of Physiotherapy and Dep. of Pulmonology | Næstved | Region Sjælland | Denmark |
| Dep. of Physiotherapy and Dep. of Pulmonology | Roskilde | Region Sjælland | Denmark |
| Dep. of Physiotherapy and Dep. of Pulmonology | Odense | Region Syddanmark | 5000 | Denmark |
| Result |
| 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. |
| D026741 |
| Physical Therapy Modalities |