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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Respiratory Distress Syndrome
• Intervention / Treatment: Device: PowerBreathe and PEP Therosold tools

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Ávila, Spain, 05005
    • Universidad Católica de Ávila

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the PowerBreathe and PEP Therosold tools group	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.
Active Comparator: perform diaphragmatic breathing, series of abdominal crunches and expiratory exercises group.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peak inspiratory pressure (PIM)	0 miminum ,200 maximum	1 month
peak expiratory pressure	0 miminum ,200 maximum	1 month
forced vital capacity	0 miminum ,200 maximum	1 month

Collaborators and Investigators

• Sponsor: Universidad Católica de Ávila

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): July 21, 2022
• Study Completion (Actual): August 24, 2022

Study Registration Dates

• First Submitted: June 26, 2022
• First Submitted That Met QC Criteria: June 26, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: 260322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No