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PEP Flute-selfcare in COVID-19

NCT04530435 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2022-03-22

No results posted yet for this study

Summary

Most research on the coronavirus SARS-CoV-2 and COVID-19 disease relate to screening measures, development of vaccines and optimising treatment of hospitalised patients. It is likely that this pandemic will be ongoing for several years until a high level of immunity is reached in the population or a vaccine has been developed. Thus, there is a need of measures to help the SARS-CoV-2 infected individual at home to overcome the course of disease with less symptoms and strain. A Positive Expiratory Pressure (PEP) flute is feasible for home use and it is possible that regular use of PEP flute may prevent the progression of respiratory symptoms in non-hospitalized individuals with COVID-19 disease.

The primary objective of the study is to examine the effect of PEP flute use among SARS-CoV-2 infected, non-hospitalized patients on self-reported change in COPD Assessment Test (CAT) score during 30 days of follow-up.

The secondary objectives are to compare the development in hospitalization rates and use of antibiotics in the intervention group and the control group during the follow-up period.

Conditions

Interventions

DEVICE

PEP flute

Participants are advised to use a PEP flute at least three times daily at an appropriate resistance. Ideally, each session consists of 15 breaths (for approximately 1 minute) repeated twice at an upright position.

Sponsors & Collaborators

  • Hvidovre University Hospital

    collaborator OTHER

  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Berit L. Heitmann, Professor, Ph.D · Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospitals, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-06
Primary Completion
2021-03-29
Completion
2021-09-01

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04530435 on ClinicalTrials.gov