NCT07204431

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

September 24, 2025

Last Update Submit

January 27, 2026

Conditions

Keywords

diaphragmatic expiratory exercises.physiotherapy tecniques

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: the PowerBreathe and PEP Therosold tools group.

perform diaphragmatic breathing and expiratory exercises group.

ACTIVE COMPARATOR
Device: the PowerBreathe and PEP Therosold tools group.

Interventions

Initially, the following data were collected from each subject in addition to basic epidemiological data.

perform diaphragmatic breathing and expiratory exercises group.the PowerBreathe and PEP Therosold tools group.

Eligibility Criteria

Age65 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Pontificia de Salamanca

Salamanca, Spain

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • Sanchez 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. Physiotherapy

Study Record Dates

First Submitted

September 24, 2025

First Posted

October 2, 2025

Study Start

August 1, 2025

Primary Completion

September 22, 2025

Study Completion

September 24, 2025

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations