Post-Acute COVID-19 Syndrome
Conditions
Keywords
exercise, mobile app, physical function, cardiovascular function
Brief summary
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).
Interventions
BEHAVIORALExercise
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.
BEHAVIORALControl
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.
Sponsors
University of Nove de Julho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor will be blinded for the group of the subjects
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in 6 min-walk test distance at 12 weeks | Baseline and 12 weeks | The 6-minute walk test performed in a 30-meter corridor, measured in meters |
| Change from baseline in Glittre test at 12 weeks | 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 |
| Change from baseline in sit and stand test at 12 weeks | 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 |
| Change from baseline in Post-Covid Functional Scale at 12 weeks | Baseline and 12 weeks | The Post-COVID-19 Functional Status Scale assesses limitations following SARS-CoV-2 infection, measured as a score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Patient Functional Scale at 12 weeks | 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 |
| Change from baseline in Motor Evoked Potential at 12 weeks | 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 |
| Change from baseline in Modified Medical Research Dyspnea Scale at 12 weeks | 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 |
| Change from baseline in Chalder Physical Fatigue Scale at 12 weeks | Baseline and 12 weeks | Comprising eight specific statements about physical fatigue to confirm its presence or absence, measured as a score |
| Change from baseline in De Paul Symptom Questionnaire at 12 weeks | Baseline and 12 weeks | The questionnaire evaluate the symptoms of fatigue in different conditions, measured as a score |
| Change from baseline in Quality of Life at 12 weeks | 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 |
| Change from baseline in Frailty and Sarcopenia at 12 weeks | 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 |
| Change from baseline in Anxiety and Depressive Symptoms at 12 weeks | Baseline and 12 weeks | Levels of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale, measured as a score |
| Change from baseline in Pain at 12 weeks | Baseline and 12 weeks | Assessed using the Numeric Pain Rating Scale, measured as a score |
| Change from baseline in Movement Behavior at 12 weeks | Baseline and 12 weeks | Movement behavior will be quantified through a motion sensor, measured in minutes |
| Change from baseline in Barriers to Physical activity at 12 weeks | Baseline and 12 weeks | Specific questionnaire to assess the most prevalent environmental barriers to physical activity, measured as presence or absence |
| Post assessment of Exercise Adherence Assessment Scale | 12 weeks | Adherence to exercise interventions will be obtained with the Adherence Assessment Scale |
| Change from baseline in Blood Pressure at 12 weeks | 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 |
| Change from baseline in Cardiac Autonomic Modulation at 12 weeks | Baseline and 12 weeks | Cardiac autonomic modulation will be assessed through heart rate variability using a heart rate monitor, measured in RR intervals |
| Change from baseline in Blood Flow and Flow-mediated Dilation at 12 weeks | 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 % |
| Change in Spirometry parameters at 12 weeks | 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 |
Countries
Brazil
Contacts
CONTACTRaphael Ritti-Dias, PhD
CONTACTFernanda Corrêa, PhD
PRINCIPAL_INVESTIGATORFernanda Corrêa, PhD
University of Nove de Julho
Outcome results
None listed