Dysfunctional Breathing in Post COVID-19 Condition.

NCT ID: NCT06776263

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-15

Study Completion Date

2026-06-30

Brief Summary

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The goal of this observational study with a cross-sectional design is to investigate what signs, symptoms and assessment which can describe and explain dysfunctional breathing in patients with post COVID-19 condition. The main question aims to answer which measurements can identify and asses dysfunctional breathing in patients with post COVID-19 condition?

Participants for this study will be recruited from the ReCov cohort will be evaluated with diffrent measurments and questionnaires.

Detailed Description

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The overall aim with the proposed research project is to describe and investigate the underlying mechanisms of dysfunctional breathing and the experience of living with dysfunctional breathing in patients with post-COVID-19 conditions. In addition, validate and evaluate which methods measure dysfunctional breathing regarding content validity, conceptual validity, test-retest reliability, and sensitivity to change for patients with post-COVID-19 conditions. Furthermore, to develop and evaluate an individually adapted intervention with the aim of normalizing the breathing pattern. In the next step, to evaluate the effects of an individually adapted intervention on physical and psychological function and health-related quality of life (HRQoL) in patients with post-COVID-19 conditions, as well as to describe the patients' experiences of rehabilitation.

Methods and planned studies This project is a part of a larger multi-disciplinary and multi-professional study, ReCOV, that takes a holistic perspective on the consequences of the disease. ReCOV is a three-armed project including patients, next of kin and staff (23). Patients have been followed up at the out-patient clinic for patients with PCC at Karolinska University Hospital (K).

The longitudinal observational study is about physical and psychological recovery, objectively measured physical activity and also an interview study of the patients' overall experiences of rehabilitation after COVID-19 both in the acute and long-term perspective. In total approximately 950 patients have accepted to be apart of ReCOV and to this proposed project patients will be recruited from this cohort but also from primary care. This research project will be performed in collaboration with Karolinska Institutet, Karolinska university Hospital (K), Sahlgrenska University Hospital (SH). University of Gothenburg and primary care in Region Stockholm.

Study 1: Dysfunctional breathing in patients with post COVID-19 condition?

Aim: To investigate what signs, symptoms and assessment which can describe and explain dysfunctional breathing in patients with post COVID-19 condition.

Design: Cross-sectional design

Participants: Patients (approximately n=200) for this study will be recruited from the ReCov cohort. All patients will be \> 18 years old. Patients that state that they have persistent respiratory problems and abnormal clinical respiratory findings will be included. Patients will also be recruited from primary care if they have suspected dysfunctional breathing pattern (unable to breathe with a normal breathing pattern in standing). Exclusion Criteria: Not able to perform the measurements because of cognitive or physical impairments, ongoing intervention of breathing exercises.

Procedure and outcomes: All included patients will be evaluated for physical and psychological function, symptoms and HrQoL. The following measurements and questionnaires will be used:

Dependent variables (primary outcome):

Health-related Quality of Life (EQ-5D-5L), EQ VAS Breathing pattern by Respiratory Movement Measuring Instrument (RMMI)

Independent, confounding and possible moderating variables:

Inspiratory and expiratory muscle strength (MIP and MEP) (Micro-RPM) Chest mobility by thoracic expansion Six-minute walk to measure endurance (in meters) Spirometry Diaphragmatic ultrasound End tidal CO2 measured during exercise

Physical Activity level (Frändin/ Grimby) Nijmegen questionnaire (dysfunctional breathing) COPD Assessment Test (CAT), questionnaire of symptoms related to breathing and now commonly used for this group of patients Dyspnea (mMRC, Modified Medical Research Council, Dyspnea Scale and BORG CR10) Patient Health Questionnaire (PHQ-9) Generalized Anxiety Disorder 7-item scale (GAD-7) Breathing Pattern Assessment Tool (BPAT)

Conditions

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Post COVID-19 Condition (PCC) Dysfunctional Breathing Breathing Pattern Disorder Post-Acute COVID-19 Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with post COVID-19 condition.

Patients with post COVID-19 condition and respiratory problems.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients that state that they have persistent respiratory problems, have 2 or higher on mMRC scale or 23 and over on the Nijmegen scale will be included.

Exclusion Criteria

* Not able to perform the measurements because of cognitive or physical impairments, ongoing intervention of breathing exercises.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Malin Nygren-Bonnier

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karolinska University Hospital

Stockholm, Solna, Sweden

Site Status NOT_YET_RECRUITING

Karolinska Institutet

Huddinge, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Malin Nygren-Bonnier, Associate professor, PhD

Role: CONTACT

+46852488831

Related Links

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Other Identifiers

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2024-05930-01

Identifier Type: -

Identifier Source: org_study_id

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