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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Post-Acute COVID-19 Syndrome

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise intervention<br>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<br>* 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.<br>* Other names: Resistance exercises;|
| Sham Comparator: Control intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and 12 weeks | 
| 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 | Baseline and 12 weeks | 
| 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 | Baseline and 12 weeks | 
| 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 | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and 12 weeks | 
| 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 | Baseline and 12 weeks | 
| 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 | Baseline and 12 weeks | 
| 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 | Baseline and 12 weeks | 
| Change from baseline in De Paul Symptom Questionnaire at 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 | 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 | 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 Anxiety and Depressive Symptoms at 12 weeks | Levels of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale, measured as a score Levels of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale, comprising 14 items, with seven focused on anxiety assessment and seven on depression assessment. Levels of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale, comprising 14 items, with seven focused on anxiety assessment and seven on depression assessment. Levels of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale, comprising 14 items, with seven focused on anxiety assessment and seven on depression assessment. Levels of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale, comprising 14 items, with seven focused on anxiety assessment and s | Baseline and 12 weeks | 
| Change from baseline in Pain at 12 weeks | Assessed using the Numeric Pain Rating Scale, measured as a score | Baseline and 12 weeks | 
| Change from baseline in Movement Behavior at 12 weeks | Movement behavior will be quantified through a motion sensor (accelerometer), Actigraph brand, GT3X model, measured in minutes | Baseline and 12 weeks | 
| Change from baseline in Barriers to Physical activity at 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 | Adherence to exercise interventions will be obtained with the Adherence Assessment Scale | 12 weeks | 
| Change from baseline in Blood Pressure at 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, mobile app, physical function, cardiovascular function