Characteristics in Post Covid-19 Patients

December 6, 2023 updated by: Rodrigo Santiago Barbosa Rocha, Phd, Universidade Metodista de Piracicaba

Clinical Respiratory Investigation in Post Covid-19 Patients

To evaluate pulmonary changes and the results of a cardiopulmonary rehabilitation protocol (CPRP) in patients after SARS-VOC-2 infection. Clinical trial type study to be conducted between 2020 and 2024 involving clinical-functional cardiopulmonary imaging and blood transcriptome profile: before CPRP (T1), 2 months after CPRP (T2) and 1 year later (T3). Expected results: a) clinical, image and transcriptome changes; b) clinical-functional improvement after CPRP.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

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
    • Pará
      • Belém, Pará, Brazil, 66055-490
        • Universidade Do Estado Do Pará

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • With confirmed diagnosis for SARS-COV-2.

Exclusion Criteria:

  • With any type of simultaneous pneumopathy.
  • Patients with autoimmune disease
  • People with simultaneous infectious diseases
  • Pregnant women
  • With degenerative diseases of the nervous system or musculoskeletal system

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
The exercises performed will attend the musculoskeletal dimension of the body, which includes the muscular strength / endurance indexes, which is part of the functional-motor dimension of physical fitness related to health. The protocol will be applied in the form of sessions lasting approximately 50 minutes, performed three times a week on alternate days, for a period of 6 weeks, totaling 20 sessions. For aerobic exercises, a treadmill will be used and for anaerobic exercises, four exercises involving muscle mobility / strength in upper and lower limbs will be performed at weight training station.
Other: Exercise
Exercise with treadmil and weight training station

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characteristics of lung
Time Frame: post treatment in 3 days
In the supine position, the patient will perform deep inspiration followed by momentary apnea inside the high resolution scanner to capture cross-sectional images of the chest with smaller cuts than 1mm of collimation which helped in the detection of even small lesions.
post treatment in 3 days
Respiratory muscle strength
Time Frame: post treatment in 3 days
Respiratory muscle strength will be assessed using the digital manovacuometer. The measurement will be performed as follows the patient will be asked to empty the lungs to the residual volume and then perform an inhalation until the total lung capacity.
post treatment in 3 days

Collaborators and Investigators

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

Sponsor

Universidade Metodista de Piracicaba

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 11, 2020

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 13, 2020

First Posted (Actual)

August 17, 2020

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F110820

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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