NCT05282199

Brief Summary

Long-term COVID has been considered a clinical condition in which the patient, after the critical period of the disease, still has systemic symptoms such as muscle weakness, inability to exercise, sleep disorders and it is still unknown what happens to the pulmonary deposition process. of aerosols. In clinical practice, inspiratory muscle training has been used to treat these patients, but the effectiveness of this intervention in reducing these symptoms is still considered a gap in the literature. To evaluate the effectiveness of inspiratory muscle training in individuals who were affected by COVID-19 to improve submaximal aerobic capacity, respiratory muscle strength, sleep quality, pulmonary deposition of the inhaled radiopharmaceutical and quality of life. This is a quasi-experimental study. , in which elderly volunteers over 18 years of both sexes residing in the city of Recife-Pernambuco will participate. The sample will consist of individuals who have been affected by COVID-19, whose severity of the disease will be classified according to the criteria established by the study by Parasher (2020). 6 minutes. The pulmonary deposition of the radiopharmaceutical will be evaluated pulmonary function will be evaluated by scintigraphy while the maximum respiratory pressures will be evaluated by a manovacuometer. Subjective sleep assessment will be assessed using the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Daytime Sleepiness Scale (ESS) and objective measurement by actigraphy. Finally, quality of life will be measured by the generic Medical OutcomesStudy 36-Item Short-Form HealthSurvey (SF-36) questionnaire. In the group of post-COVID patients in which the reduction in endurance and inspiratory muscle power are identified, an inspiratory muscle training (IMT) will be performed with a load equivalent to 50% of the MIP (assessed weekly), for eight weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable covid19

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

2.4 years

First QC Date

March 7, 2022

Last Update Submit

July 11, 2025

Conditions

Keywords

COVID-19Inspiratory muscle trainingscintigraphyradioaerosol distributioninhalation therapy

Outcome Measures

Primary Outcomes (1)

  • Radioaerosol Pulmonary Deposition

    Amount of radiodrug deposited in the lungs after inhalation

    3 minutes

Study Arms (1)

IMT group

EXPERIMENTAL

In the group of post-COVID patients in which reduced endurance and inspiratory muscle power are identified, inspiratory muscle training (IMT) will be performed with a load equivalent to 50% of MIP (assessed weekly) for eight weeks.

Other: INSPIRATORY MUSCLE TRAINING

Interventions

In the group of post-COVID-19 patients in which reduced endurance and inspiratory muscle power are identified, inspiratory muscle training (IMT) will be performed with a load equivalent to 50% of MIP (assessed weekly) for eight weeks.

Also known as: Powerbreath® ClassicLight
IMT group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of all genders, over 18 years of age, who are not undergoing any type of post-infection treatment, with a diagnosis through RT-PCR positive for the Coronavirus, who fall within the period of up to 10 days after hospital discharge will be included. .

You may not qualify if:

  • Individuals with previous orthopedic, neurological problems or any cardiovascular or respiratory disease in their clinical history, pregnant women and patients in the active phase of infection for the coronavirus, or who cannot maintain proper positioning during the scintigraphy exam will be excluded pulmonary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, Brazil

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • ARMELE DORNELAS DE ANDRADE, PhD

    Universidade Federal de Pernambuco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 16, 2022

Study Start

March 1, 2022

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

There is not

Locations