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Dysfunctional BreathingDB-REHABNCT06707623

CPET Guided Rehab vs Physiotherapy in Patients With Dysfunctional Breathing

A study testing Respiratory Physiotherapy and Pulmonary Rehabilitation in people with Dysfunctional Breathing, run by Evangelismos Hospital at 1 site in Greece.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dysfunctional Breathing
What is being tested?
Respiratory Physiotherapy and Pulmonary Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteGreece
Study dates
27 Nov 2024to 30 Nov 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andreas Asimakos, MD, PhD contact

+302132043395

silverakos@gmail.com

Greece1 site, 1 recruiting
  • Pulmonary Rehabilitation Unit, 1st Department of Critical Care and Pulmonary Services Evangelismos Hospital

    Athens, Attica, 10676

    Andreas Asimakos, MD PhD, +302132043395, apokatastasi_eva@hotmail.com

    Recruiting

Other trials in Greece

About this study

Official title: Cardiopulmonary Exercise Testing Guided Physiotherapy During Pulmonary Rehabilitation in Patients With Dysfunctional Breathing, a Randomized Controlled 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.

Read the 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.

Being tested
Respiratory Physiotherapy, Pulmonary Rehabilitation
Keywords
Dysfunctional Breathing, Pulmonary Rehabilitation, Breathing retraining

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Respiratory PhysiotherapyOther

    Physiotherapy 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 RehabilitationOther

    Pulmonary 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.

Study groups in NCT06707623
Study groupRoleWhat they receive
Pulmonary Rehabilitation GroupExperimentalPatients with Dysfunctional Breathing participating in an individualized Rehab Program that will combine exercise and breathing retraining
Receives: Other: Pulmonary Rehabilitation
Physiotherapy GroupExperimentalPatients with dysfunctional breathing in this group will receive respiratory physiotherapy (breathing retraining)
Receives: Other: Respiratory Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiopulmonary exercise testing (CPET)

    Measured: At enrolment and after 8/9 weeks (depends on study arm).

Secondary outcomes (7)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: At enrolment and after 8/9 weeks (depends on study arm).

  5. The 36-Item Short Form Health Survey (SF-36)

    The 36-Item Short Form Health Survey (SF-36). The SF-36 is a questionnaire with 36 items that measures health-related quality of life. The 36 questions are separated into 8 scales and 2 composite scales that summarize physical and mental health. The 8 domains are: Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE) and Mental Health (MH). The 2 composites for physical and mental health are Physical Composite Summary (PCS) and Mental Composite Summary (MCS). Domain and summary components scores range from 0 to 100, with higher score represents better quality of life and well - being. With scoring algorithms, score from all the domains place on scales with mean scores equal to 50.

    Measured: At enrolment and after 8/9 weeks (depends on study arm).

  6. Modified Medical Research Council (mMRC) Dyspnea Scale

    The Modified Medical Research Council (mMRC) Dyspnea Scale is a 5 point scale based on the sensation of dyspnea during patients daily activities with 0 identifying patients that only get breathless with strenuous exercise and 4 patients that are too breathless to get dressed or leave home. MMRC scale is mostly used to stratify patients based on symptoms and due το limited levels of classification is frequently unable to detect small changes, yet both groups in the present study showed statistically significant changes.

    Measured: At enrolment and after 8/9 weeks (depends on study arm).

  7. Airway occlusion pressure P0.1

    Airway occlusion pressure (P0.1) is the drop in airway pressure (Paw) 100 milliseconds after the onset of inspiration during an end-expiratory occlusion of the airway. It is, in theory, a reliable measure of respiratory drive because the brevity of the occlusion explains that it is not affected by patient's response to the occlusion and it is independent of respiratory mechanics.

    Measured: At enrolment and after 8/9 weeks (depends on study arm).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2024
  2. Study start27 Nov 2024
  3. Primary completion30 Nov 2028 (estimated)
  4. Study completion30 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a parallel designed randomized controlled trial with an allocation ratio of 1 control to 1 rehabilitation patient.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06707623
Sponsor's protocol ID
564/21-11-24
Acronym
DB-REHAB
Status last verified
Mar 2026
First submitted
25 Nov 2024
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Sharing individual participant data is prohibited by the hospital's patient privacy policy. Patient data may only be used for the purposes of this study.

Publications

  • 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.

    PubMed 4009520
  • 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.

    PubMed 28905471
  • 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.

    PubMed 37024133
  • 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.

    PubMed 37433720

Questions about this trial

What is this clinical trial studying?

A study testing Respiratory Physiotherapy and Pulmonary Rehabilitation in people with Dysfunctional Breathing, run by Evangelismos Hospital at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andreas Asimakos, MD, PhD (+302132043395, silverakos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiopulmonary exercise testing (CPET) (time frame: At enrolment and after 8/9 weeks (depends on study arm).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06707623, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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