COVID-19NCT05435443
Comparison of Two Respiratory Physiotherapy Treatments in Postcovid-19 Patients.
A study testing PowerBreathe and PEP Therosold tools in people with COVID-19 and Respiratory Distress Syndrome, run by Universidad Católica de Ávila at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19, Respiratory Distress Syndrome
- What is being tested?
- PowerBreathe and PEP Therosold tools
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2022to 24 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COVID-19, Respiratory Distress Syndrome
- Being tested
- PowerBreathe and PEP Therosold tools
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PowerBreathe and PEP Therosold toolsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| the PowerBreathe and PEP Therosold tools group | Experimental | Not described Receives: Device: PowerBreathe and PEP Therosold tools |
| perform diaphragmatic breathing, series of abdominal crunches and expiratory exercises group. | Active comparator | Not described Receives: Device: PowerBreathe and PEP Therosold tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak inspiratory pressure (PIM)
0 miminum ,200 maximum
Measured: 1 month
peak expiratory pressure
0 miminum ,200 maximum
Measured: 1 month
forced vital capacity
0 miminum ,200 maximum
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Jul 2022
- Primary completion21 Jul 2022
- Study completion24 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica de Ávila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435443
- Sponsor's protocol ID
- 260322
- Status last verified
- Mar 2023
- First submitted
- 26 Jun 2022
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 18283429Thomas 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.
PubMed 32312646Lazzeri 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.
PubMed 32236089Coronaviridae 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.
PubMed 32123347Pal 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.
PubMed 32337143Sanchez-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.
PubMed 38111659
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Respiratory Physiotherapy Treatments in Postcovid-19 Patients. Randomiced Clinical Trial
- ClinicalTrials.gov ID
- NCT05435443
- Acronym / sponsor ID
- 260322
- Conditions
- COVID-19, Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universidad Católica de ÁvilaUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PowerBreathe and PEP Therosold toolsInitially, 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. | Device | perform diaphragmatic breathing, series of abdominal crunches and expiratory exercises group., the PowerBreathe and PEP Therosold tools group |
Primary outcome
peak inspiratory pressure (PIM)
Time frame: 1 month
0 miminum ,200 maximum
peak expiratory pressure
Time frame: 1 month
0 miminum ,200 maximum
forced vital capacity
Time frame: 1 month
0 miminum ,200 maximum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Background: PubMed 18283429Gosselink 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 publication: PubMed 32312646Thomas 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 publication: PubMed 32236089Lazzeri 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 publication: PubMed 32123347Coronaviridae 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 publication: PubMed 32337143Pal 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.
- Derived from this study: PubMed 38111659Sanchez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PowerBreathe and PEP Therosold tools in people with COVID-19 and Respiratory Distress Syndrome, run by Universidad Católica de Ávila at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak inspiratory pressure (PIM) (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05435443, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.