Dysfunctional Breathing in Post COVID-19 Condition.

NCT06776263 | Recruiting

• 1 other identifier: 2024-05930-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Keywords

Respiration; Dyspnea; Signs and Symptoms, Respiratory; Hyperventilation; Outcome Assessment, Health Care; Patient Outcome Assessment; Surveys and Questionnaires

Outcome Measures

Primary Outcomes (1)

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

  Will be assesed in a supine position, using the RMMI. First, during 30 seconds of tidal volume breathing. Second, during 60 seconds of performing maximal breathing manoeuvres interspaced by tidal volume breathing and then during 60 seconds after performing activity that triggers dyspnea. The RMMI records bilateral changes in the anterior posterior diameter, including both upper and lower thoracic and abdominal movements. Health-related Quality of Life is measured with EuroQualityOf Life 5 dimensions questionnaire (EQ-5D-5L), which is an instrument that evaluates the generic quality of life. EQ-5D includes a descriptive system, which comprises 5 dimensions of health: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. A descriptive index-score between 0-1, higher score indicates higher HRQoL. EQ-5D also includes a visual analog scale (VAS), which records self-rated health status on a graduated (0-100) scale, with higher scores for higher HRQoL

  Assessment will be applied only once and takes about 5-10 minutes to be completed.

Secondary Outcomes (17)

• Maximal Inspiratory Pressure (MIP)

  Assessment will be applied only once and takes about 5-10 minutes to be completed.

• Maximal Expiratory Pressure ( MEP)

  Assessment will be applied only once and takes about 5-10 minutes to be completed.

• Chest mobility

  Assessment will be applied only once and takes about 5 minutes to be completed.

• Six-minute walk test (6MWT)

  Assessment will be applied only once and takes about 15 minutes to be completed.

• Spirometry

  Assessment will be applied only once and takes about 30 minutes to be completed.

Study Arms (1)

Patients with post COVID-19 condition.

Patients with post COVID-19 condition and respiratory problems.

Eligibility Criteria

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

Study Population

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)

You may qualify if:

• 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.

You may not qualify if:

• Not able to perform the measurements because of cognitive or physical impairments, ongoing intervention of breathing exercises.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (2)

Karolinska University Hospital

Stockholm, Solna, 17176, Sweden

NOT YET RECRUITING

Karolinska Institutet

Huddinge, 14183, Sweden

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Respiratory Aspiration; Dyspnea; Signs and Symptoms, Respiratory; Hyperventilation

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms

Central Study Contacts

Malin Nygren-Bonnier, Associate professor, PhD

CONTACT

+46852488831; malin.nygren-bonnier@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 15, 2025
• Study Start: January 15, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

SE (2)