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Effect of PEP flute self-care versus usual care in early covid-19: non-drug, open label, randomised controlled trial in a Danish community setting

OBJECTIVE: To determine whether positive expiratory pressure (PEP) by PEP flute self-care is effective in reducing respiratory symptoms among community dwelling adults with SARS-CoV-2 infection and early stage covid-19. DESIGN: Non-drug, open label, randomised controlled trial. SETTING: Capital Regi...

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Autores principales: Mollerup, Annette, Henriksen, Marius, Larsen, Sofus Christian, Bennetzen, Anita Selmer, Simonsen, Mette Kildevæld, Kofod, Linette Marie, Knudsen, Jenny Dahl, Nielsen, Xiaohui Chen, Weis, Nina, Heitmann, Berit Lilienthal
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10476062/
https://www.ncbi.nlm.nih.gov/pubmed/34819329
http://dx.doi.org/10.1136/bmj-2021-066952
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author Mollerup, Annette
Henriksen, Marius
Larsen, Sofus Christian
Bennetzen, Anita Selmer
Simonsen, Mette Kildevæld
Kofod, Linette Marie
Knudsen, Jenny Dahl
Nielsen, Xiaohui Chen
Weis, Nina
Heitmann, Berit Lilienthal
author_facet Mollerup, Annette
Henriksen, Marius
Larsen, Sofus Christian
Bennetzen, Anita Selmer
Simonsen, Mette Kildevæld
Kofod, Linette Marie
Knudsen, Jenny Dahl
Nielsen, Xiaohui Chen
Weis, Nina
Heitmann, Berit Lilienthal
author_sort Mollerup, Annette
collection PubMed
description OBJECTIVE: To determine whether positive expiratory pressure (PEP) by PEP flute self-care is effective in reducing respiratory symptoms among community dwelling adults with SARS-CoV-2 infection and early stage covid-19. DESIGN: Non-drug, open label, randomised controlled trial. SETTING: Capital Region and Region Zealand in Denmark from 6 October 2020 to 26 February 2021. PARTICIPANTS: Community dwelling adults, able to perform self-care, with a new SARS-CoV-2 infection (verified by reverse transcription polymerase chain reaction tests) and symptoms of covid-19. INTERVENTION: Participants were randomised to use PEP flute self-care in addition to usual care or have usual care only. Randomisation was based on permuted random blocks in a 1:1 ratio, stratified for sex and age (<60 or ≥60 years). The PEP self-care group was instructed to use a PEP flute three times per day during the 30 day intervention. MAIN OUTCOME MEASURES: Primary outcome was a change in symptom severity from baseline to day 30, as assessed by the self-reported COPD (chronic obstructive pulmonary disease) assessment test (CAT), which was adjusted for baseline values and stratification factors. Participants completed the CAT test questionnaire every day online. Secondary outcomes were self-reported urgent care visits due to covid-19, number of covid-19 related symptoms, and change in self-rated health, all within 30-days’ follow-up. RESULTS: 378 participants were assigned to the PEP flute self-care intervention (n=190) or usual care only (n=188). In the PEP self-care group, the median number of days with PEP flute use was 21 days (interquartile range 13-25). For the intention-to-treat population, a group difference was observed in changes from baseline in CAT scores of −1.2 points (95% confidence interval −2.1 to −0.2; P=0.017) in favour of the PEP flute self-care group. At day 30, the PEP flute self-care group also reported less chest tightness, less dyspnoea, more vigour, and higher level of daily activities, but these differences were small, and no consistent effects were seen on the secondary outcomes. No serious adverse events were reported. CONCLUSIONS: In community dwelling adults with early covid-19, PEP flute self-care had a significant, yet marginal and uncertain clinical effect on respiratory symptom severity, as measured by CAT scores. TRIAL REGISTRATION: ClinicalTrials.gov NCT04530435.
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spelling pubmed-104760622023-09-05 Effect of PEP flute self-care versus usual care in early covid-19: non-drug, open label, randomised controlled trial in a Danish community setting Mollerup, Annette Henriksen, Marius Larsen, Sofus Christian Bennetzen, Anita Selmer Simonsen, Mette Kildevæld Kofod, Linette Marie Knudsen, Jenny Dahl Nielsen, Xiaohui Chen Weis, Nina Heitmann, Berit Lilienthal BMJ Research OBJECTIVE: To determine whether positive expiratory pressure (PEP) by PEP flute self-care is effective in reducing respiratory symptoms among community dwelling adults with SARS-CoV-2 infection and early stage covid-19. DESIGN: Non-drug, open label, randomised controlled trial. SETTING: Capital Region and Region Zealand in Denmark from 6 October 2020 to 26 February 2021. PARTICIPANTS: Community dwelling adults, able to perform self-care, with a new SARS-CoV-2 infection (verified by reverse transcription polymerase chain reaction tests) and symptoms of covid-19. INTERVENTION: Participants were randomised to use PEP flute self-care in addition to usual care or have usual care only. Randomisation was based on permuted random blocks in a 1:1 ratio, stratified for sex and age (<60 or ≥60 years). The PEP self-care group was instructed to use a PEP flute three times per day during the 30 day intervention. MAIN OUTCOME MEASURES: Primary outcome was a change in symptom severity from baseline to day 30, as assessed by the self-reported COPD (chronic obstructive pulmonary disease) assessment test (CAT), which was adjusted for baseline values and stratification factors. Participants completed the CAT test questionnaire every day online. Secondary outcomes were self-reported urgent care visits due to covid-19, number of covid-19 related symptoms, and change in self-rated health, all within 30-days’ follow-up. RESULTS: 378 participants were assigned to the PEP flute self-care intervention (n=190) or usual care only (n=188). In the PEP self-care group, the median number of days with PEP flute use was 21 days (interquartile range 13-25). For the intention-to-treat population, a group difference was observed in changes from baseline in CAT scores of −1.2 points (95% confidence interval −2.1 to −0.2; P=0.017) in favour of the PEP flute self-care group. At day 30, the PEP flute self-care group also reported less chest tightness, less dyspnoea, more vigour, and higher level of daily activities, but these differences were small, and no consistent effects were seen on the secondary outcomes. No serious adverse events were reported. CONCLUSIONS: In community dwelling adults with early covid-19, PEP flute self-care had a significant, yet marginal and uncertain clinical effect on respiratory symptom severity, as measured by CAT scores. TRIAL REGISTRATION: ClinicalTrials.gov NCT04530435. BMJ Publishing Group Ltd. 2021-11-24 /pmc/articles/PMC10476062/ /pubmed/34819329 http://dx.doi.org/10.1136/bmj-2021-066952 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Research
Mollerup, Annette
Henriksen, Marius
Larsen, Sofus Christian
Bennetzen, Anita Selmer
Simonsen, Mette Kildevæld
Kofod, Linette Marie
Knudsen, Jenny Dahl
Nielsen, Xiaohui Chen
Weis, Nina
Heitmann, Berit Lilienthal
Effect of PEP flute self-care versus usual care in early covid-19: non-drug, open label, randomised controlled trial in a Danish community setting
title Effect of PEP flute self-care versus usual care in early covid-19: non-drug, open label, randomised controlled trial in a Danish community setting
title_full Effect of PEP flute self-care versus usual care in early covid-19: non-drug, open label, randomised controlled trial in a Danish community setting
title_fullStr Effect of PEP flute self-care versus usual care in early covid-19: non-drug, open label, randomised controlled trial in a Danish community setting
title_full_unstemmed Effect of PEP flute self-care versus usual care in early covid-19: non-drug, open label, randomised controlled trial in a Danish community setting
title_short Effect of PEP flute self-care versus usual care in early covid-19: non-drug, open label, randomised controlled trial in a Danish community setting
title_sort effect of pep flute self-care versus usual care in early covid-19: non-drug, open label, randomised controlled trial in a danish community setting
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10476062/
https://www.ncbi.nlm.nih.gov/pubmed/34819329
http://dx.doi.org/10.1136/bmj-2021-066952
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