Assessment of Functional Capacity in Long-COVID

Long COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05967039
• Other study ID #: 30135320.0.0000.5259
• Status: Active, not recruiting
• Start date: August 8, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Centro Universitário Augusto Motta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Long COVID
• Post-COVID-19 Syndrome

Intervention

Other:
• Physiotherapy
Physiotherapy in respiratory rehabilitation

Locations

Country	Name	City	State
Brazil	Agnaldo José Lopes	Rio de Janeiro
Brazil	Centro Universitario Augusto Motta	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitário Augusto Motta

Country where clinical trial is conducted

Brazil, 

References & Publications (57)

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* Note: There are 57 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Impulse oscillometry	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
Secondary	Spirometry	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
Secondary	Lung ultrasound	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
Secondary	Functional Status scale PCFS	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