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NCT Number: NCT06168006

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Nove de Julho

São Paulo, 01504-001, Brazil

Location status: Recruiting

Location contact

Raphael Dias

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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: Rehabilitation, Physical activity, Endurance, Resistance exercises

Control

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. Post assessment of Exercise Adherence Assessment Scale

    Time frame: 12 weeks

    Adherence to exercise interventions will be obtained with the Adherence Assessment Scale

  13. 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

  14. 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

  15. 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 %

  16. 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

Other outcomes

  1. 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

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fernanda Corrêa, PhD

CONTACT

[email protected]

+55 11 97344-0380

Raphael Ritti-Dias, PhD

CONTACT

[email protected]

+55 19 99940 6878

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

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

Acronym: Recovery

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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