NCT05967039

Brief Summary

A paucity of prognostic studies in patients with post-COVID-19 syndrome (long-COVID) shows the need to identify the main effects on functional capacity in the short and medium term. In this regard, the evaluation of lung function, lung structure and functional capacity in long-COVID patients is essential to estimate the impact of the disease. This retrospective observational study aims to compare functional capacity, lung function, and lung ultrasound findings in patients who underwent physical therapy to those who did not.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

2 active sites

Status
unknown

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 8, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 7, 2023

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

July 3, 2023

Last Update Submit

August 3, 2023

Conditions

Keywords

Functional capacity;Six-minute walk test;Spirometry;Oscillometry;Lung Ultrasound;Ventilometry;

Outcome Measures

Primary Outcomes (1)

  • Six-minute walk test coupled into the measurement of pulmonary ventilation

    The individuals will undergo the six-minute walk test coupled to the measurement of ventilation using equipment using a face mask with monitoring of ventilatory variables and vital signs on a 30-meter track where the purpose is to assess the functional capacity

    October 2023

Secondary Outcomes (4)

  • Impulse oscillometry

    October 2023

  • Spirometry

    October 2023

  • Lung ultrasound

    October 2023

  • Functional Status scale PCFS

    October 2023

Study Arms (2)

Control

This is a control group of individuals who were diagnosed with post-COVID-19 syndrome but did not underwent Physiotherapy.

Other: Physiotherapy

Intervention

This is an intervention group of individuals who were diagnosed with post-COVID-19 syndrome and underwent Physiotherapy

Other: Physiotherapy

Interventions

Physiotherapy in respiratory rehabilitation

ControlIntervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with long-COVID-19 syndrome

You may qualify if:

  • Individuals with an established diagnosis of COVID-19 (RT-PCR) who required hospitalization or not, regardless of whether or not they were treated in the ICU.

You may not qualify if:

  • Patients unable to perform the tests. Patients with musculoskeletal disorders not associated with COVID-19. Patients with lung, heart or cerebrovascular diseases not associated with COVID-19.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Agnaldo José Lopes

Rio de Janeiro, 22745-271, Brazil

Location

Centro Universitario Augusto Motta

Rio de Janeiro, 22745271, Brazil

Location

Related Publications (57)

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MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2023

First Posted

August 1, 2023

Study Start

August 8, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 7, 2023

Record last verified: 2023-07

Locations