Chronic Obstructive Pulmonary DiseaseNCT07204431
Efficacy of Respiratory Physiotherapy Treatment in Chronic Obstructive Disease.
A study testing the PowerBreathe and PEP Therosold tools group. in people with Chronic Obstructive Pulmonary Disease, 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 been diagnosed with chronic obstructive pulmonary disease, comparing with two randomized groups, for the performance of different respiratory musculature training protocols. Read more about this study
- Who is it for?
- Ages 65 to 110 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- the PowerBreathe and PEP Therosold tools group.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2025to 24 Sep 2025
- 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 65 to 110 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients diagnosed with chronic obstructive disease.
- Patients older than 65 years.
- Patients under age.
- Patients with cognitive ability to perform spirometry.
- Patients with physical ability to perform spirometry.
Who cannot join
- Patients without functional limitations in the respiratory system.
- Patients under 65 years of age.
- Patients with no cognitive ability to perform spirometry.
- Patients without physical ability to perform spirometry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Respiratory Physiotherapy Treatment in Patients With Chronic Obstructive Disease in Elderly Patients.
To test the effectiveness of a respiratory physiotherapy treatment plan in patients who have been diagnosed with chronic obstructive pulmonary disease, comparing with two randomized groups, for the performance of different respiratory musculature training protocols. Objectify the data obtained through ultrasound and spirometry, observing the differences obtained at the beginning and end of the study, verifying the efficacy of the PowerBreathe® and Therosold PEP® tools and the effectiveness of diaphragmatic, abdominal and expiratory exercises.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- the PowerBreathe and PEP Therosold tools group.
- Keywords
- diaphragmatic expiratory exercises., physiotherapy tecniques
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the PowerBreathe and PEP Therosold tools group.Device
Initially, the following data were collected from each subject in addition to basic epidemiological data.
| Study group | Role | What they receive |
|---|---|---|
| the PowerBreathe and PEP Therosold tools group. | Experimental | Not described Receives: Device: the PowerBreathe and PEP Therosold tools group. |
| perform diaphragmatic breathing and expiratory exercises group. | Active comparator | Not described Receives: Device: the PowerBreathe and PEP Therosold tools group. |
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 posted2 Oct 2025
- Study start1 Aug 2025
- Primary completion22 Sep 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 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 Pontificia de Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204431
- Sponsor's protocol ID
- 092025
- Status last verified
- Jan 2026
- First submitted
- 24 Sep 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32312646Gosselink 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 18283429Lazzeri 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 32236089Sanchez Mila Z, Rodriguez Sanz D, Martin Nieto A, Jimenez Lobo A, Ramos Hernandez M, Campon Chekroun A, Frutos Llanes R, Barragan Casas JM, Velazquez Saornil J. Effects of a respiratory and neurological rehabilitation treatment plan in post Covid-19 affected university students. Randomized clinical study. Chron Respir Dis. 2024 Jan-Dec;21:14799731241255967. doi: 10.1177/14799731241255967.
PubMed 38752418
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Respiratory Physiotherapy Treatment in Patients With Chronic Obstructive Disease in Elderly Patients.
- ClinicalTrials.gov ID
- NCT07204431
- Acronym / sponsor ID
- 092025
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- diaphragmatic expiratory exercises., physiotherapy tecniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Católica de ÁvilaUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 2 Oct 2025 (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 been diagnosed with chronic obstructive pulmonary disease, comparing with two randomized groups, for the performance of different respiratory musculature training protocols. Objectify the data obtained through ultrasound and spirometry, observing the differences obtained at the beginning and end of the study, verifying the efficacy of the PowerBreathe® and Therosold PEP® tools and the effectiveness of diaphragmatic, abdominal and expiratory exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the PowerBreathe and PEP Therosold tools group. | Experimental | Device: the PowerBreathe and PEP Therosold tools group. |
| perform diaphragmatic breathing and expiratory exercises group. | Active comparator | Device: the PowerBreathe and PEP Therosold tools group. |
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with chronic obstructive disease.
- Patients older than 65 years.
- Patients under age.
- Patients with cognitive ability to perform spirometry.
- Patients with physical ability to perform spirometry.
Key exclusion criteria (4 listed)
- Patients without functional limitations in the respiratory system.
- Patients under 65 years of age.
- Patients with no cognitive ability to perform spirometry.
- Patients without physical ability 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 |
|---|---|---|
| the PowerBreathe and PEP Therosold tools group.Initially, the following data were collected from each subject in addition to basic epidemiological data. | Device | perform diaphragmatic breathing 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 29 Jan 2026.
- 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 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 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 38752418Sanchez Mila Z, Rodriguez Sanz D, Martin Nieto A, Jimenez Lobo A, Ramos Hernandez M, Campon Chekroun A, Frutos Llanes R, Barragan Casas JM, Velazquez Saornil J. Effects of a respiratory and neurological rehabilitation treatment plan in post Covid-19 affected university students. Randomized clinical study. Chron Respir Dis. 2024 Jan-Dec;21:14799731241255967. doi: 10.1177/14799731241255967.
- Individual participant dataSharing planned: Undecided
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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 the PowerBreathe and PEP Therosold tools group. in people with Chronic Obstructive Pulmonary Disease, 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 4 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 29 Jan 2026. 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 NCT07204431, which also lists 4 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 29 Jan 2026.