CPET Guided Rehab vs Physiotherapy in Patients With Dysfunctional Breathing
ConditionDysfunctional Breathing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEvangelismos Hospital
About this trial
In this study the efficacy of a pulmonary rehabilitation program tailored to the needs of patients with dysfunctional breathing (DB) will be investigated using cardiopulmonary exercise testing. The pulmonary rehabilitation program will be compared with physiotherapy which is currently the mainstream therapy of DB.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Dysfunctional breathing (DB) diagnosed with CPET.
Adult patients (>18 years of age)
Able and willing to attend an outpatient multidisciplinary, supervised rehabilitation program of a total duration of two months (8 weeks).
Able and willing to attend 5 physiotherapy sessions over a period of 9 weeks.
Disqualifiers
No underling pathology explaining dyspnea and DB in CPET (e.g normal dead space to tidal volume ratio (VD/Vt) and normal alveolar-arterial (A-a) gradient.)
Patients with COPD
Patients with uncontrolled asthma
Patients with post-exertional malaise (PEM).
Trial design
Design model
Parallel
Treatments tested in this trial
Respiratory Physiotherapy
Other interventionPhysiotherapy will include: Progressive breathing retraining, neurosensory training, nose breathing training, activity modification, inhalation-exhalation ratio training, dynamic respiratory control training and instructions for continuing all of the above training at home. Total 5 sessions in 9 weeks time.
Pulmonary Rehabilitation
Other interventionPulmonary Rehabilitation will be completed in 16 sessions (2 times a week for 8 weeks). It will combine exercise with breathing retraining guided by CPET findings regarding erratic breathing pattern and/or hyperventilation.
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: Pulmonary Rehabilitation GroupExperimental treatment 1 intervention
Group B: Physiotherapy GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cardiopulmonary exercise testing (CPET)
Time frame
At enrolment and after 8/9 weeks (depends on study arm).Secondary outcomes
1
The Nijmegen questionnaire (NQ)
The Nijmegen questionnaire (NQ) has been widely used as a screening tool for DB with a cut-off score of ≥23 however, NQ was design for detecting hyperventilation syndrome which is frequent, yet not universal, in DB patients. The lowest value is 0 and the highest is 64 with higher scores indicating more severe symptoms and worst outcomes.
Time frame
At enrolment and after 8/9 weeks (depends on study arm).2
The Breathing Pattern Assessment Tool (BPAT)
The Breathing Pattern Assessment Tool (BPAT) was specifically designed as a semiobjective screening tool for characterization and qualification of the key features of DB namely both hyperventilation and breathing pattern disorders. A cutoff score of ≥4 is highly sensitive (0.92) and specific (0.75) in diagnosing DB. the lowest score is 0 and the highest is 14. Higher scores indicate more symptoms and worst outcomes.
Time frame
At enrolment and after 8/9 weeks (depends on study arm).3
The Breathing Vigilance (V-Q) Questionnaire
The Breathing Vigilance (V-Q) Questionnaire was developed to measure breathing vigilance which, if increased, may contribute to DB and could be a therapeutic target. A cut-off score of 16.5 has optimal sensitivity (0.718) and specificity (0.681) in differentiating between high and low DB risk . The lowest score is 11 and the highest is 55. Higher scores indicate higher breathing vigilance and worst outcomes.
Time frame
At enrolment and after 8/9 weeks (depends on study arm).4
The Hospital Acquired and Depression Scale (HADS)
The Hospital Acquired and Depression Scale (HADS) is a 14 items questionnaire that measures anxiety and depression in general medical population. In ARDS survivals the minimal clinically important difference is 2.0-2.5 for the HADS-A and HADS-D. In patients surviving acute lung injury and treated in ICU mean HADS scores remained unchanged in over 2 years follow up (6 for HADS-A and 5 for HADS-D). These values were lower than the threshold of 8 for substantial symptoms of anxiety or depression. The score ranges from 0 to 21 with highest values indicating more anxiety and depression and worst outcomes.
Time frame
At enrolment and after 8/9 weeks (depends on study arm).Sponsors and contacts
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Source ClinicalTrials.gov