Comparison of Two Respiratory Physiotherapy Treatments in Postcovid-19 Patients.

COVID-19 Clinical Trial

Official title:

Comparison of Two Respiratory Physiotherapy Treatments in Postcovid-19 Patients. Randomiced Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05435443
• Other study ID #: 260322
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: August 24, 2022

Study information

• Verified date: March 2023
• Source: Universidad Católica de Ávila
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 24, 2022
• Est. primary completion date: July 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• PowerBreathe and PEP Therosold tools
Initially, the following data were collected from each subject in addition to basic epidemiological data: M-mode diaphragmatic excursion measurements, both in inspiration and expiration via ultrasound; spirometry is also carried out, obtaining values of forced vital capacity (FVC or FVC), forced expiratory volume (FEV), portion of FVC (FEV1/FVC), peak expiratory flow (PEF), mean expiratory flow, peak inspiratory pressure (PIM) and peak expiratory pressure (PEM). A 30-day treatment plan was carried out in which one group (Tool Group) had to perform 5 minutes of exercise with each tool, alternating with one minute of rest between each minute of exercise, starting with the Therosold PEP® and then the PowerBreathe®. The resistances applied to the devices were marked according to the specific assessment of each subject, in relation to the spirometric values of PIM and PEM.

Locations

Country	Name	City	State
Spain	Universidad Católica de Ávila	Ávila

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica de Ávila

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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/s41564-0 — View 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. — View 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 infectio — View 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. — View 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 recommendat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peak inspiratory pressure (PIM)	0 miminum ,200 maximum	1 month
Primary	peak expiratory pressure	0 miminum ,200 maximum	1 month
Primary	forced vital capacity	0 miminum ,200 maximum	1 month