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Completed

NCT Number: NCT05435443

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Católica de Ávila

Ávila, 05005, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. peak inspiratory pressure (PIM)

    Time frame: 1 month

    0 miminum ,200 maximum

  2. peak expiratory pressure

    Time frame: 1 month

    0 miminum ,200 maximum

  3. forced vital capacity

    Time frame: 1 month

    0 miminum ,200 maximum

Sponsors and collaborators

Lead sponsor

Universidad Católica de Ávila

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2022
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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