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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Nove de Julho

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Exercise interventionExperimental treatment 1 intervention
Group B: Control interventionSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in 6 min-walk test distance at 12 weeks

The 6-minute walk test performed in a 30-meter corridor, measured in meters

Time frame
Baseline and 12 weeks
2

Change from baseline in Glittre test at 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

Time frame
Baseline and 12 weeks
3

Change from baseline in sit and stand test at 12 weeks

The test consists in rising from a chair as many times as possible within 30 seconds, measured in number of repetitions

Time frame
Baseline and 12 weeks
4

Change from baseline in Post-Covid Functional Scale at 12 weeks

The Post-COVID-19 Functional Status Scale assesses limitations following SARS-CoV-2 infection, measured as a score

Time frame
Baseline and 12 weeks

Secondary outcomes

1

Change from baseline in Patient Functional Scale at 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

Time frame
Baseline and 12 weeks
2

Change from baseline in Motor Evoked Potential at 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

Time frame
Baseline and 12 weeks
3

Change from baseline in Modified Medical Research Dyspnea Scale at 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

Time frame
Baseline and 12 weeks
4

Change from baseline in Chalder Physical Fatigue Scale at 12 weeks

Comprising eight specific statements about physical fatigue to confirm its presence or absence, measured as a score

Time frame
Baseline and 12 weeks

Other outcomes

1

System Usability Scale

Scale used to assess the individuals' perception of the app's usability in the group submitted to the intervention

Time frame
12 weeks
2

The User Experience Questionnaire

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.

Time frame
12 weeks
3

Focal group

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.

Time frame
12 weeks

Sponsors and contacts

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