Clinical trial NCT06707623: CPET Guided Rehab vs Physiotherapy in Patients With Dysfunctional Breathing
Official title: Cardiopulmonary Exercise Testing Guided Physiotherapy During Pulmonary Rehabilitation in Patients With Dysfunctional Breathing, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysfunctional Breathing
Keywords: Dysfunctional Breathing
Pulmonary Rehabilitation
Breathing retraining
Lead sponsor: Evangelismos Hospital
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a parallel designed randomized controlled trial with an allocation ratio of 1 control to 1 rehabilitation patient.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Dysfunctional breathing (DB) is a common disorder affecting 9% of the general population and almost 1/3 of patients with underline pulmonary disease such as asthma or COPD. To date physiotherapy utilizing breathing retraining remains the mainstay treatment however, there is lack of evidence regarding the efficacy of these treatments or the superiority of one over the other in terms of symptom relief. Moreover, still there is no consensus on the diagnosis of DB patients and no gold standard diagnostic method exists.

R Boulding et. al. classified DB in to five categories incorporating the main characteristics of patients with DB which are hyperventilation and abnormal/irregular breathing patterns including periodic deep sighing, thoracic dominant breathing, forced abdominal expiration and thoraco-abdominal asynchrony. Patients may demonstrate one or more of the above breathing patterns which are also observed in diseases like asthma, COPD, heart failure, neuromuscular disease and panic/anxiety disorder. To date the main tools for diagnosing/ evaluating DB are expert physiotherapists examination, questionnaires and Cardiopulmonary exercise testing (CPET).

The Nijmegen questionnaire (NQ) has been widely used as a screening tool for DB2 with a cut-off score of ≥23 however, NQ was design for detecting hyperventilation syndrome which is frequent, yet not universal, in DB patients, common in various respiratory conditions and thus poorly agrees with expert respiratory physiotherapists evaluation in detecting DB. The NQ may miss other manifestations of DB like thoracoabdominal asynchrony or apical breathing. 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 DB9. 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.

CPET could be a valuable tool in diagnosing and assessing dysfunctional breathing. In contrast to questionnaires CPET can be used to objectively assess breathing pattern disorders and provide evidence for further investigations when an underlying disease is suspected. Moreover, as an objective measurement is more reliable in re-assessing DB patients after treatment since there is no "learning effect" from either the patient nor the therapist who both want the therapy to succeed. Assessing end-tidal PCO2 (PETCO2), air blood gases (ABGs) and ventilatory equivalent for VCO2 (VE/VCO2), could help diagnosing DB and ruling out concurrent pathology.

Since breathing retraining remains the main treatment of DB there is an urgent need for further treatment options. Pulmonary rehabilitation has been established as an essential and successful treatment in patients with diseases with high prevalence of DB such as Chronic Obstructive Pulmonary Disease (COPD) and asthma whereas the American Thoracic and European Respiratory Society urge for enhancing the implementation, usage, and Delivery of Pulmonary Rehabilitation in various diseases. We hypothesize that a rehabilitation program with integrated dynamic physiotherapy sessions guided by CPET will be more efficient in the treatment of DB patients than physiotherapy alone. The aim of the present study is to compare a rehabilitation program designed specifically for DB, utilizing CPET for diagnosis and treatment guidance, with breathing retraining alone.

Eligibility criteria: Inclusion Criteria:

* 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.
* Sign an informed consent.

Exclusion Criteria:

* 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).
* Patients that cannot attend an outpatient rehabilitation program like suffering from dementia, chronically paralyzed, with paraplegia, multiple injuries, or other serious orthopaedic problems that cause disability or suffer from very serious underlying diseases such as end-stage cancer, and patients with neurological diseases that cause disability, require specialized rehabilitation clinics and special interventions (speech therapy, kinesiotherapy, etc.).

Primary outcomes:
measure: Cardiopulmonary exercise testing (CPET)
timeFrame: At enrolment and after 8/9 weeks (depends on study arm).
Secondary outcomes:
measure: The Nijmegen questionnaire (NQ)
timeFrame: At enrolment and after 8/9 weeks (depends on study arm).
measure: The Breathing Pattern Assessment Tool (BPAT)
timeFrame: At enrolment and after 8/9 weeks (depends on study arm).
measure: The Breathing Vigilance (V-Q) Questionnaire
timeFrame: At enrolment and after 8/9 weeks (depends on study arm).
measure: The Hospital Acquired and Depression Scale (HADS)
timeFrame: At enrolment and after 8/9 weeks (depends on study arm).
measure: The 36-Item Short Form Health Survey (SF-36)
timeFrame: At enrolment and after 8/9 weeks (depends on study arm).
measure: Modified Medical Research Council (mMRC) Dyspnea Scale
timeFrame: At enrolment and after 8/9 weeks (depends on study arm).
measure: Airway occlusion pressure P0.1
timeFrame: At enrolment and after 8/9 weeks (depends on study arm).
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Pulmonary Rehabilitation Unit, 1st Department of Critical Care and Pulmonary Services Evangelismos Hospital
state: Attica
Study officials:
References:
citation: van Dixhoorn J, Duivenvoorden HJ. Efficacy of Nijmegen Questionnaire in recognition of the hyperventilation syndrome. J Psychosom Res. 1985;29(2):199-206. doi: 10.1016/0022-3999(85)90042-x.
citation: Todd S, Walsted ES, Grillo L, Livingston R, Menzies-Gow A, Hull JH. Novel assessment tool to detect breathing pattern disorder in patients with refractory asthma. Respirology. 2018 Mar;23(3):284-290. doi: 10.1111/resp.13173. Epub 2017 Sep 14.
citation: Steinmann J, Lewis A, Ellmers TJ, Jones M, MacBean V, Kal E. Validating the Breathing Vigilance Questionnaire for use in dysfunctional breathing. Eur Respir J. 2023 Jun 8;61(6):2300031. doi: 10.1183/13993003.00031-2023. Print 2023 Jun.
citation: Genecand L, Altarelli M, Binkova A, Loew S, Vaudan S, Gex G, Bridevaux PO, Fresard I. Dysfunctional breathing symptoms, functional impact and quality of life in patients with long COVID-19: a prospective case series. BMJ Open Respir Res. 2023 Jul;10(1):e001770. doi: 10.1136/bmjresp-2023-001770.