Acute Cardiovascular Responses to a Single Exercise Session in Patients With Post-COVID-19 Syndrome (ExPostCovid-19)

December 3, 2024 updated by: Raphael Mendes Ritti Dias, University of Nove de Julho

Acute Cardiovascular Responses to a Single Exercise Session in Patients With Post-Covid-19 Syndrome

The objective of the study is to compare the acute cardiorespiratory and perceptual responses to a physical exercise session in those infected by Covid-19 with and without persistent symptoms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will be a crossover carried out in two groups (with and without persistent symptoms of Covid-19). Participants in both groups will undergo a control session and an exercise session and cardiorespiratory and perceptual responses will be obtained before, during and after the sessions. In the exercise session, participants will perform aerobic exercises, strength exercises and muscle stretching, while in the control session participants will remain seated. Blood pressure, heart rate, cardiac autonomic modulation, peripheral oxygen saturation, vascular function and perception of affect will be obtained.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 01504-001
        • Recruiting
        • Universidade Nove de Julho
        • Contact:
          • Raphael Dias

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Post-Covid Syndrome group:

  • have had a positive RT-PCR test for Covid-19;
  • present persistent symptoms of Post Covid 19 syndrome, which have no other health explanation according to the criteria of the World Health Organization (WHO);
  • have the cognitive and physical capacity to perform the exercises; It is
  • low cardiovascular risk classification according to the American College of Sports Medicine criteria.

Healthy group:

  • not present persistent symptoms of Post Covid 19 syndrome, which have no other health explanation according to the criteria of the World Health Organization (WHO);
  • have the cognitive and physical capacity to perform the exercises; It is
  • low cardiovascular risk classification according to the American College of Sports Medicine criteria.

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise
In the exercise session, participants will perform aerobic, free active and flexibility exercises and will last approximately 45 minutes.
Behavioral: Exercise session
Session will included aerobic, resistance and flexibility exercises and will last approximately 45 minutes. The session will begin with aerobic exercises (5 min jumping jacks and 5 min stationary walking). Then, nine strength exercises will be performed for the main muscle groups (3 times of 12 to 15 repetitions, with a 1-minute rest interval) and finally stretching for the main muscle groups
Other Names:
  • Rehabilitation
  • Flexibility
  • Resistance exercises
  • Cardiorespiratory exercises
Behavioral: Control session
Remain seated for 60 min
Other: Control
In the control session, participants will remain seated for 60 minutes.
Behavioral: Exercise session
Session will included aerobic, resistance and flexibility exercises and will last approximately 45 minutes. The session will begin with aerobic exercises (5 min jumping jacks and 5 min stationary walking). Then, nine strength exercises will be performed for the main muscle groups (3 times of 12 to 15 repetitions, with a 1-minute rest interval) and finally stretching for the main muscle groups
Other Names:
  • Rehabilitation
  • Flexibility
  • Resistance exercises
  • Cardiorespiratory exercises
Behavioral: Control session
Remain seated for 60 min

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Blood pressure
Time Frame: Before and 30 and 50 minutes after the end of the exercise and control interventions
Assessment of the systolic and diastolic blood pressure using an automatic device
Before and 30 and 50 minutes after the end of the exercise and control interventions
Change in Heart rate variability
Time Frame: Before and 30 and 50 minutes after the end of the exercise and control interventions
Assessment of the heart rate variability indicators using a heart rate monitor
Before and 30 and 50 minutes after the end of the exercise and control interventions
Change in flow mediated dilation
Time Frame: Before and 30 minutes after the end of the exercise and control interventions
Assessment of the flow mediated dilation using a doppler ultrasound
Before and 30 minutes after the end of the exercise and control interventions
Change in peak exhalation flow
Time Frame: Before and 5 minutes after the end of the exercise and control interventions
Assessment of the peak exhalation flow using a peak flow device
Before and 5 minutes after the end of the exercise and control interventions
Change in oxygen saturation
Time Frame: Before, during and 5 minutes after the end of the exercise and control interventions
Assessment of the peripheral oxygen saturation using a pulse oximeter
Before, during and 5 minutes after the end of the exercise and control interventions

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in heart rate
Time Frame: Before and continuously during exercise and control interventions
Assessment of heart rate using a heart rate monitor
Before and continuously during exercise and control interventions
Change in affective response
Time Frame: Before and every 5 minutes during exercise and control interventions
Assessment of affective response using a felling scale
Before and every 5 minutes during exercise and control interventions

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nove de Julho

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Raphael Dias, PhD, University of Nove de Julho

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Acute_Covid
  • 0057/2022 (Other Identifier: CAPES)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Plan to share the data after completion upon resonable request

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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