CPET Guided Rehab vs Physiotherapy in Patients With Dysfunctional Breathing

NCT06707623 | Recruiting DMC

• 1 other identifier: 564/21-11-24
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysfunctional Breathing

Keywords

Dysfunctional Breathing; Pulmonary Rehabilitation; Breathing retraining

Outcome Measures

Primary Outcomes (1)

• Cardiopulmonary exercise testing (CPET)

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

Secondary Outcomes (7)

• The Nijmegen questionnaire (NQ)

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

• The Breathing Pattern Assessment Tool (BPAT)

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

• The Breathing Vigilance (V-Q) Questionnaire

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

• The Hospital Acquired and Depression Scale (HADS)

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

• The 36-Item Short Form Health Survey (SF-36)

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

Study Arms (2)

Pulmonary Rehabilitation Group

EXPERIMENTAL

Patients with Dysfunctional Breathing participating in an individualized Rehab Program that will combine exercise and breathing retraining

Other: Pulmonary Rehabilitation

Physiotherapy Group

EXPERIMENTAL

Patients with dysfunctional breathing in this group will receive respiratory physiotherapy (breathing retraining)

Other: Respiratory Physiotherapy

Interventions

Respiratory Physiotherapy OTHER

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.

Physiotherapy Group

Pulmonary Rehabilitation OTHER

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.

Pulmonary Rehabilitation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Evangelismos Hospital: lead

Study Sites (1)

Pulmonary Rehabilitation Unit, 1st Department of Critical Care and Pulmonary Services Evangelismos Hospital

Athens, Attica, 10676, Greece

RECRUITING

Related Publications (4)

• 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.

  PMID: 4009520 BACKGROUND

• 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.

  PMID: 28905471 BACKGROUND

• 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.

  PMID: 37024133 BACKGROUND

• 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.

  PMID: 37433720 BACKGROUND

Central Study Contacts

Andreas Asimakos, MD, PhD

CONTACT

+302132043395; silverakos@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Pulmonologist and Director of the Pulmonary Rehabilitation Department

Model Details: This is a parallel designed randomized controlled trial with an allocation ratio of 1 control to 1 rehabilitation patient.

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: November 27, 2024
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)