An interventional study of Breathing Exercises and Usual care in Dysfunctional Breathing in Asthma, sponsored by Naestved Hospital. Completed at 8 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Naestved Hospital · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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
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
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.
Also known as: BrEX
Participants will receive only short information given initially at recruitment. No instruction or booklet will be distributed in the Usual care-Group.
Also known as: UC
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.
Accelerometry (METs, TEE)
Average metabolic equivalents (METs) and Total energy expenditure (TEE) 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 (FVC, PEF)
Spirometry (MedikroPro) will be used to measure forced vital capacity (FVC), units liter, and peak expiratory flow rate (PEF), units liter/minute.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to 6 months follow up.
Borg CR10
Dyspnoe will be measured before and after 6MWD by the Borg CR10.
Time frame: 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.
Time frame: Change from baseline to 3, 6, and 12 months follow up.
Socio Economic Status (SES)
Socio Economic Status (SES) includes education, work status, income.
Time frame: 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.
Time frame: Only assessed at baseline.
Plan to share: Undecided
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Naestved Hospital