Dysfunctional Breathing in Asthma Clinical Trial
— BEAT_DBOfficial title:
BEAT DB-study; Breathing Exercises in Asthma Targeting Dysfunctional Breathing-a Randomised Controlled Trial
| Verified date | March 2024 |
| Source | Naestved Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 190 |
| Est. completion date | August 31, 2024 |
| Est. primary completion date | April 14, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Dep. of Physiotherapy and Dep. of Pulmonology | Aalborg | Region North |
| Denmark | Dep. of Physiotherapy and Dep. of Pulmonology | Bispebjerg | Danish Capital Region |
| Denmark | Allergi og Lungeklinikken Helsingør | Helsingør | Danish Capital Region |
| Denmark | Dep. of Physiotherapy and Dep. of Pulmonology | Hvidovre | Danish Capital Region |
| Denmark | Dep. of Physiotherapy and Dep. of Pulmonology | Naestved | Region Zealand |
| Denmark | Dep. of Physiotherapy and Dep. of Pulmonology | Odense | Region Of Southern Denmark |
| Denmark | Dep. of Physiotherapy and Dep. of Pulmonology | Roskilde | Region Zealand |
| Denmark | Dep. of Physiotherapy and Dep. of Pulmonology | Silkeborg | Central Denmark Region |
| Lead Sponsor | Collaborator |
|---|---|
| Naestved Hospital | 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 |
Denmark,
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( — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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. | |
| Other | 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. | |
| Other | 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. | |
| Other | 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. | |
| Other | 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. | |
| Other | 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. | |
| Other | 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. | |
| Other | 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. | |
| Other | 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. | |
| Other | 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. | |
| Other | 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. | |
| Other | 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. | |
| Other | Borg CR10 | Dyspnoe will be measured before and after 6MWD by the Borg CR10. | Change from baseline to 6 months follow up. | |
| Other | 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. | |
| Other | Socio Economic Status (SES) | Socio Economic Status (SES) includes education, work status, income. | Only assessed at baseline. | |
| Other | 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. | |
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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. | |
| Secondary | 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. | |
| Secondary | 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. |