Comparison of Two Respiratory Physiotherapy Treatments in Postcovid-19 Patients.
Primary Purpose
COVID-19, Respiratory Distress Syndrome
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PowerBreathe and PEP Therosold tools
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
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.
Sites / Locations
- Universidad Católica de Ávila
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
the PowerBreathe and PEP Therosold tools group
perform diaphragmatic breathing, series of abdominal crunches and expiratory exercises group.
Arm Description
Outcomes
Primary Outcome Measures
peak inspiratory pressure (PIM)
0 miminum ,200 maximum
peak expiratory pressure
0 miminum ,200 maximum
forced vital capacity
0 miminum ,200 maximum
Secondary Outcome Measures
Full Information
NCT ID
NCT05435443
First Posted
June 26, 2022
Last Updated
March 24, 2023
Sponsor
Universidad Católica de Ávila
1. Study Identification
Unique Protocol Identification Number
NCT05435443
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 21, 2022 (Actual)
Study Completion Date
August 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica de Ávila
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the PowerBreathe and PEP Therosold tools group
Arm Type
Experimental
Arm Title
perform diaphragmatic breathing, series of abdominal crunches and expiratory exercises group.
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
PowerBreathe and PEP Therosold tools
Intervention Description
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.
Primary Outcome Measure Information:
Title
peak inspiratory pressure (PIM)
Description
0 miminum ,200 maximum
Time Frame
1 month
Title
peak expiratory pressure
Description
0 miminum ,200 maximum
Time Frame
1 month
Title
forced vital capacity
Description
0 miminum ,200 maximum
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Universidad Católica de Ávila
City
Ávila
ZIP/Postal Code
05005
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18283429
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.
Results Reference
background
PubMed Identifier
32312646
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.
Results Reference
result
PubMed Identifier
32236089
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.
Results Reference
result
PubMed Identifier
32123347
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.
Results Reference
result
PubMed Identifier
32337143
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.
Results Reference
result
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Comparison of Two Respiratory Physiotherapy Treatments in Postcovid-19 Patients.
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