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

NCT05435443 | Completed

• 1 other identifier: 260322
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

the PowerBreathe and PEP Therosold tools group

EXPERIMENTAL

Device: PowerBreathe and PEP Therosold tools

perform diaphragmatic breathing, series of abdominal crunches and expiratory exercises group.

ACTIVE COMPARATOR

Device: PowerBreathe and PEP Therosold tools

Interventions

PowerBreathe and PEP Therosold tools DEVICE

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.

perform diaphragmatic breathing, series of abdominal crunches and expiratory exercises group.; the PowerBreathe and PEP Therosold tools group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Universidad Católica de Ávila: lead

Study Sites (1)

Universidad Católica de Ávila

Ávila, 05005, Spain

Location

Related Publications (6)

• 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.

  PMID: 18283429 BACKGROUND

• 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.

  PMID: 32312646 RESULT

• 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.

  PMID: 32236089 RESULT

• 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.

  PMID: 32123347 RESULT

• 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.

  PMID: 32337143 RESULT

• Sanchez-Mila Z, Abuin-Porras V, Romero-Morales C, Almazan-Polo J, Velazquez Saornil J. Effectiveness of a respiratory rehabilitation program including an inspiration training device versus traditional respiratory rehabilitation: a randomized controlled trial. PeerJ. 2023 Dec 15;11:e16360. doi: 10.7717/peerj.16360. eCollection 2023.

  PMID: 38111659 DERIVED

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: June 28, 2022
• Study Start: July 1, 2022
• Primary Completion: July 21, 2022
• Study Completion: August 24, 2022
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)