Exercise Training Using an App on Physical Cardiovascular Function Individuals With Post-covid-19 Syndrome (Recovery)

February 16, 2026 updated by: Raphael Mendes Ritti Dias, University of Nove de Julho

Effects of a Physical Training Program Using a Mobile App on the Functionality and Cardiovascular Function of Individuals With Post-covid-19 Syndrome: Randomized Clinical Trial

The aim of this study is to assess the effect of a physical exercise program via a mobile application on functional parameters in individuals with post-COVID-19 syndrome. This is a clinical trial involving 60 individuals with post-COVID syndrome who will be randomly assigned to either a control group (physical activity guideline) or an experimental group (app-based training).

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.

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.
60

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
      • São Paulo, 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

No

Description

Inclusion Criteria:

  • Laboratory diagnosis of COVID-19
  • Fatigue ≥ 8 points on the Chalder Scale and/or dyspnea 2-4 on the Modified Medical Research Council
  • Have access to a smartphone
  • Have no contraindications for exercise practice
  • Have ability to sit and stand and maintain balance while standing
  • Have preserved cognitive function
  • Have no risk of falls according to the Morse Fall Scale

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: Parallel 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 intervention
The subjects randomized to this group will perform three app-based training sessions per week for 12 weeks, each session lasting a maximum of 40 minutes.
Behavioral: Exercise
The experimental group will undergo an exercise program using the Recovery App. Participants will receive guidance from researchers about the functionality of the app. The Recovery App includes flexibility, strength, and aerobic training exercises, aiming for a progressive intensity and volume over the weeks.
Other Names:
  • Physical activity
  • Rehabilitation
  • Endurance
  • Resistance exercises
Sham Comparator: Control intervention
This group will receive a booklet with exercise instructions, and will be recommended the same frequency and duration of exercise as the experimental group
Behavioral: Control
They will receive an exercise booklet based on the Brazilian Physical Activity Recommendations (MINISTRY OF HEALTH, 2021), which recommend 150 minutes of physical activity for adults and seniors.

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 from baseline in 6 min-walk test distance at 12 weeks
Time Frame: Baseline and 12 weeks
The 6-minute walk test performed in a 30-meter corridor, measured in meters
Baseline and 12 weeks
Change from baseline in Glittre test at 12 weeks
Time Frame: Baseline and 12 weeks
The test consists in rise from a chair, carry a weighted backpack, walk 10 meters, climb stairs, move objects between shelves (1 kg each), and return. They perform tasks sequentially, transferring items up and down shelves. The route is retraced, ending by sitting back in the initial chair, measured in seconds
Baseline and 12 weeks
Change from baseline in sit and stand test at 12 weeks
Time Frame: Baseline and 12 weeks
The test consists in rising from a chair as many times as possible within 30 seconds, measured in number of repetitions
Baseline and 12 weeks
Change from baseline in Post-Covid Functional Scale at 12 weeks
Time Frame: Baseline and 12 weeks
The Post-COVID-19 Functional Status Scale assesses limitations following SARS-CoV-2 infection, measured as a score
Baseline and 12 weeks

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 from baseline in Patient Functional Scale at 12 weeks
Time Frame: Baseline and 12 weeks
The Patient Functional Scale allows individuals to identify 3 to 5 important activities they consider themselves unable to perform or are having difficulty with due to their condition, measured in a score
Baseline and 12 weeks
Change from baseline in Motor Evoked Potential at 12 weeks
Time Frame: Baseline and 12 weeks
The cortical excitability of the quadriceps motor area will be measured using Motor Evoked Potential results in microvolts (µV) using the Transcranial Magnetic Stimulation equipment model MagPro R20 (MagVenture, Denmark) with the parabolic coil model MMC-140-II, measured in kgf
Baseline and 12 weeks
Change from baseline in Modified Medical Research Dyspnea Scale at 12 weeks
Time Frame: Baseline and 12 weeks
This scale comprises five items, allowing the patient to select the item that corresponds to how much their dyspnea limits their daily life activities, measured as a score
Baseline and 12 weeks
Change from baseline in Chalder Physical Fatigue Scale at 12 weeks
Time Frame: Baseline and 12 weeks
Comprising eight specific statements about physical fatigue to confirm its presence or absence, measured as a score
Baseline and 12 weeks
Change from baseline in De Paul Symptom Questionnaire at 12 weeks
Time Frame: Baseline and 12 weeks
The questionnaire evaluate the symptoms of fatigue in different conditions, measured as a score
Baseline and 12 weeks
Change from baseline in Quality of Life at 12 weeks
Time Frame: Baseline and 12 weeks
To assess quality of life, the 12-Item Short-Form Health Survey will be used, consisting of twelve items that evaluate eight different dimensions influencing quality of life, measured as a score
Baseline and 12 weeks
Change from baseline in Frailty and Sarcopenia at 12 weeks
Time Frame: Baseline and 12 weeks
Frailty will be assessed using the Tilburg Frailty Indicator, while sarcopenia will be evaluated through the Sarcopenia Form questionnaire, both measured as a score
Baseline and 12 weeks
Change from baseline in Pain at 12 weeks
Time Frame: Baseline and 12 weeks
Assessed using the Numeric Pain Rating Scale, measured as a score
Baseline and 12 weeks
Change from baseline in Barriers to Physical activity at 12 weeks
Time Frame: Baseline and 12 weeks
Specific questionnaire to assess the most prevalent environmental barriers to physical activity, measured as presence or absence
Baseline and 12 weeks
Post assessment of Exercise Adherence Assessment Scale
Time Frame: 12 weeks
Adherence to exercise interventions will be obtained with the Adherence Assessment Scale
12 weeks
Change from baseline in Blood Pressure at 12 weeks
Time Frame: Baseline and 12 weeks
The clinical resting blood pressure will be assessed using automatic blood pressure monitoring equipment (HEM-7113, OMRON®, Brazil), measured in mmHg
Baseline and 12 weeks
Change from baseline in Cardiac Autonomic Modulation at 12 weeks
Time Frame: Baseline and 12 weeks
Cardiac autonomic modulation will be assessed through heart rate variability using a heart rate monitor, measured in RR intervals
Baseline and 12 weeks
Change from baseline in Blood Flow and Flow-mediated Dilation at 12 weeks
Time Frame: Baseline and 12 weeks
The measurements of basal blood flow and flow-mediated vasodilation will be obtained through ultrasonography in brachial artery, measured in ml/min or %
Baseline and 12 weeks
Change from baseline in Anxiety and Depressive Symptoms at 12 weeks
Time Frame: Baseline and 12 weeks
Levels of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale, measured as a score
Baseline and 12 weeks
Change from baseline in Movement Behavior at 12 weeks
Time Frame: Baseline and 12 weeks
Movement behavior will be quantified through a motion sensor, measured in minutes
Baseline and 12 weeks
Change in Spirometry parameters at 12 weeks
Time Frame: Baseline and 12 weeks
Changes in Forced vital capacity, forced expiratory volume in the first second, Peak expiratory flow, forced expiratory flow 25-75% and FEV 1 /FVC ratio
Baseline and 12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
System Usability Scale
Time Frame: 12 weeks
Scale used to assess the individuals' perception of the app's usability in the group submitted to the intervention
12 weeks
The User Experience Questionnaire
Time Frame: 12 weeks
The questionnaire will be applied in experimental group to collect information regarding the user's overall experience with the app, such as: general perception, overall experience, main barriers, and key difficulties in using the app.
12 weeks
Focal group
Time Frame: 12 weeks
The focus group will be conducted via video conference with 4 to 10 individuals that participated in experimental group. The guiding questions will aim to understand the user's perception, from usability to effectiveness, including satisfaction and potential improvements to the app.
12 weeks

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.
  • Principal Investigator: Fernanda Corrêa, 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.
March 1, 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.
June 30, 2026

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.
June 30, 2026

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).
December 12, 2023

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.
December 12, 2023

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.
December 13, 2023

Study Record Updates

Last Update Posted (Actual)

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.
February 17, 2026

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.
February 16, 2026

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.
February 1, 2026

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.
  • Recovery Long Covid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available after the completion of the study and the finalization of the main articles of this projects

IPD Sharing Time Frame

After the publication of the main articles of the study.

IPD Sharing Access Criteria

Upon reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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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