Assessment of Functional Capacity in Long-COVID

August 3, 2023 updated by: Centro Universitário Augusto Motta

Evaluation of Lung Function, Lung Ultrasound and Functional Capacity in Long-COVID Patients Who Underwent Physical Therapy

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction: The pandemic caused by the Severe acute respiratory syndrome by coronavirus 2 (SARS-CoV-2) has been presented as a one of the greatest health challenges on a global scale at the beginning of this millennium. Many patients need physical therapy in their recovery process. A paucity of prognostic studies in patients with long-COVID shows the need to identify the main repercussions 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.

Objective: The present study aims to compare functional capacity, lung function, and lung ultrasound findings between patients diagnosed with long-COVID who underwent physical therapy to those who did not.

Methods: This is a retrospective observational study with quantitative data analysis. The study will be carried out at the Pulmonary Function Laboratory of the Policlínica Universitária Piquet Carneiro, from the State University of Rio de Janeiro. First, a clinical evaluation will be performed. In the survey, it will be asked whether the patient had undergone physical therapy treatment, so they can be allocated in the control or intervention group. After that, they will answer to the Post-COVID-19 Functional Status Scale (PCFS), a tool to measure functional status over time after COVID-19. Then, patients will have their lung function evaluated through spirometry and impulse oscillometry (IOS). In addition, lung ultrasound (LUS) images will be analyzed. And their functional capacity will be assessed using the six-minute walk test (6MWT) coupled to pulmonary ventilation measurement using Spiropalm® (Spiropalm 6MWT, Cosmed, Rome, Italy).

It is expected that understanding the consequences of long-COVID on pulmonary ventilation can help to design therapeutic strategies in rehabilitation services.

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil, 22745271
        • Centro Universitário Augusto Motta
      • Rio de Janeiro, Brazil, 22745-271
        • Agnaldo José Lopes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with long-COVID-19 syndrome

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
This is a control group of individuals who were diagnosed with post-COVID-19 syndrome but did not underwent Physiotherapy.
Other: Physiotherapy
Physiotherapy in respiratory rehabilitation
Intervention
This is an intervention group of individuals who were diagnosed with post-COVID-19 syndrome and underwent Physiotherapy
Other: Physiotherapy
Physiotherapy in respiratory rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six-minute walk test coupled into the measurement of pulmonary ventilation
Time Frame: October 2023
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spirometry
Time Frame: October 2023
It is a procedure that allows the diagnosis of ventilatory disorders and is capable of measuring the patient's pulmonary function - evaluating the volume and velocity of the air blown. It is done with the aid of a device, the spirometer. The patient breathes into this device and internal sensors measure the amount of air and air movement in the lungs.
October 2023
Functional Status scale PCFS
Time Frame: October 2023
The Post-COVID-19 Functional Status scale: a tool to measure functional status over time after COVID-19, being a self-administered questionnaire for the patient who will be informed: how much are you currently affected in your daily life by COVID 19? The patient will indicate in a classification from 0 to 4 their degree of functional status
October 2023
Impulse oscillometry
Time Frame: October 2023
The IOS will be performed using an impulse oscillometer (Quark i2m, Cosmed, Rome Italy). During the IOS assessment, participants will be guided to stay seated, keeping the head in a neutral position, with manual support on the cheeks and with the nostrils occluded by a clip and then they will breathe usually for 40 seconds (ALBUQUERQUE et al., 2015). The values of acceptable minimum coherence will be ≥0.9 Hz. The following resistive and reactive parameters were evaluated: Rsr at 4 Hz (R4), 6 Hz (R6), 10 Hz (R10) and 20 Hz (R20); average resistance between 4-20 Hz (Rm); heterogeneity of resistance between R4 and R20 (R4-R20); resonant frequency (Fres); and area under reactance curve (AX). The values of R4, R6, R10 and R20 will be considered 34 abnormal when ≥150% of predicted (OOSTVEEN et al., 2013). A change in Fres and AX will be considered when >12 Hz and >3.60 cm H2O/L/s, respectively (BERGER et al., 2013).
October 2023
Lung ultrasound
Time Frame: October 2023
Participants will perform the LUS on Aplio XG equipment Aplio XG (Toshiba Medical Systems, Tokyo, Japan) coupled to a linear transducer 7.5-10 megahertz (MHz) multi-frequency transducer or a 3.5-5 MHz convex transducer in B. All USP evaluations will be performed by the authors who, although not whether they are radiologists, they are all employees of Policlínica Piquet Carneiro and have at least least 9 years of USP experience at the participant screening site. All USP assessments will be performed by 2 examiners and, when disagreement between them will be resolved through collective discussion. With participants in a seated position, the capture of USP signals will be done in 6 areas of each hemithorax as follows (SOUMMER et al., 2012): two anterior, two side and two back. In the evaluation of the pathological signs of USP, the investigators will search for B lines >2, coalescing B lines, and subpleural consolidations (MAFORT et al., 2021).
October 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Universitário Augusto Motta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2022

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

July 28, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30135320.0.0000.5259

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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