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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
190
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.
Participants will receive only short information given initially at recruitment. No instruction or booklet will be distributed in the Usual care-Group.
Dep. of Physiotherapy and Dep. of Pulmonology
Silkeborg, Central Jutland, Denmark
Dep. of Physiotherapy and Dep. of Pulmonology
Bispebjerg, Danish Capital Region, Denmark
Allergi og Lungeklinikken Helsingør
Elsinore, Danish Capital Region, 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, Denmark
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).
Time frame: Primary endpoint: Change from baseline to 6 months follow up. Secondary endpoints will be 3 and 12 months follow up.
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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: Change from baseline to 6 months follow up.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.