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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
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.
Universidade Nove de Julho
São Paulo, São Paulo, Brazil
RECRUITINGChange 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
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
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
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 12 weeks
Change from baseline in Pain at 12 weeks
Assessed using the Numeric Pain Rating Scale, measured as a score
Time frame: Baseline and 12 weeks
Change from baseline in Movement Behavior at 12 weeks
Movement behavior will be quantified through a motion sensor, measured in minutes
Time frame: 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
Time frame: Baseline and 12 weeks
Post assessment of Exercise Adherence Assessment Scale
Adherence to exercise interventions will be obtained with the Adherence Assessment Scale
Time frame: 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
Time frame: 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
Time frame: 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 %
Time frame: Baseline and 12 weeks
Change in Spirometry parameters at 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
Time frame: Baseline and 12 weeks