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

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

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 Overview

• Status: Recruiting
• Conditions: Post-Acute COVID-19 Syndrome
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Control

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raphael Ritti-Dias, PhD; Phone Number: +55 19 99940 6878; Email: raphaelritti@gmail.com
• Study Contact Backup: Name: Fernanda Corrêa, PhD; Phone Number: +55 11 97344-0380; Email: fecorrea@uninove.br

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01504-001
      • Recruiting
      • Universidade Nove de Julho
      • Contact: Raphael Dias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise intervention; 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; 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: Physical activity; Rehabilitation; Endurance; Resistance exercises
Sham Comparator: Control intervention; 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; 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.

What is the study measuring?

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 Pain at 12 weeks	Assessed using the Numeric Pain Rating Scale, measured as a score	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
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	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	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	Baseline and 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Scale	Scale used to assess the individuals' perception of the app's usability in the group submitted to the intervention	12 weeks
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.	12 weeks
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.	12 weeks

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Investigators: Principal Investigator: Fernanda Corrêa, PhD, University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: exercise; physical function; cardiovascular function; mobile app
• Additional Relevant MeSH Terms: Post-Infectious Disorders; COVID-19; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; Behavior; Post-Acute COVID-19 Syndrome; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Aftercare; Continuity of Patient Care; Exercise; Rehabilitation
• Other Study ID Numbers: Recovery Long Covid

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available after the completion of the study and the finalization of the main articles of this projects
• IPD Sharing Time Frame: After the publication of the main articles of the study.
• IPD Sharing Access Criteria: Upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No