Clinical trial NCT05435443: Comparison of Two Respiratory Physiotherapy Treatments in Postcovid-19 Patients.
Official title: Comparison of Two Respiratory Physiotherapy Treatments in Postcovid-19 Patients. Randomiced Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Respiratory Distress Syndrome
Lead sponsor: Universidad Católica de Ávila
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the effectiveness of a respiratory physiotherapy treatment plan in patients who have passed COVID-19, comparing two randomized groups, for the performance of different respiratory musculature training protocols. To objectify the results data obtained by means of ultrasound measurements and spirometry, observing the differences obtained at the beginning and end of the study, verifying the effectiveness of the PowerBreathe® ,Therosold PEP® tools and the effectiveness of diaphragmatic, abdominal and expiratory exercises.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Covid and suffering from functional limitations in the respiratory system.
* Patients over 18 years of age.
* Patients under 65 years of age.
* Patientes with cognitive ability to perform spirometry.
* Patients with the physical capacity to perform spirometry

Exclusion Criteria:

* - Patients diagnosed with Covid and without functional limitations in the respiratory system.
* Patients under 18 years of age.
* Patients over 65 years of age.
* Patients without cognitive capacity to perform spirometry.
* Patients without physical capacity to perform spirometry.

Primary outcomes:
measure: peak inspiratory pressure (PIM)
timeFrame: 1 month
measure: peak expiratory pressure
timeFrame: 1 month
measure: forced vital capacity
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ávila
country: Spain
facility: Universidad Católica de Ávila
Study officials:
References:
citation: Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schonhofer B, Stiller K, van de Leur H, Vincent JL. Physiotherapy for adult patients with critical illness: recommendations of the European Respiratory Society and European Society of Intensive Care Medicine Task Force on Physiotherapy for Critically Ill Patients. Intensive Care Med. 2008 Jul;34(7):1188-99. doi: 10.1007/s00134-008-1026-7. Epub 2008 Feb 19.
citation: Thomas P, Baldwin C, Bissett B, Boden I, Gosselink R, Granger CL, Hodgson C, Jones AY, Kho ME, Moses R, Ntoumenopoulos G, Parry SM, Patman S, van der Lee L. Physiotherapy management for COVID-19 in the acute hospital setting: clinical practice recommendations. J Physiother. 2020 Apr;66(2):73-82. doi: 10.1016/j.jphys.2020.03.011. Epub 2020 Mar 30.
citation: Lazzeri M, Lanza A, Bellini R, Bellofiore A, Cecchetto S, Colombo A, D'Abrosca F, Del Monaco C, Gaudiello G, Paneroni M, Privitera E, Retucci M, Rossi V, Santambrogio M, Sommariva M, Frigerio P. Respiratory physiotherapy in patients with COVID-19 infection in acute setting: a Position Paper of the Italian Association of Respiratory Physiotherapists (ARIR). Monaldi Arch Chest Dis. 2020 Mar 26;90(1). doi: 10.4081/monaldi.2020.1285.
citation: Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.
citation: Pal M, Berhanu G, Desalegn C, Kandi V. Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2): An Update. Cureus. 2020 Mar 26;12(3):e7423. doi: 10.7759/cureus.7423.