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

NCT06168006 | Recruiting

• 1 other identifier: Recovery Long Covid
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Post-Acute COVID-19 Syndrome

Keywords

exercise; mobile app; physical function; cardiovascular function

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (16)

• Change from baseline in Patient Functional Scale at 12 weeks

  Baseline and 12 weeks

• Change from baseline in Motor Evoked Potential at 12 weeks

  Baseline and 12 weeks

• Change from baseline in Modified Medical Research Dyspnea Scale at 12 weeks

  Baseline and 12 weeks

• Change from baseline in Chalder Physical Fatigue Scale at 12 weeks

  Baseline and 12 weeks

• Change from baseline in De Paul Symptom Questionnaire at 12 weeks

  Baseline and 12 weeks

Other Outcomes (3)

• System Usability Scale

  12 weeks

• The User Experience Questionnaire

  12 weeks

• Focal group

  12 weeks

Study Arms (2)

Exercise intervention

EXPERIMENTAL

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

Control intervention

SHAM COMPARATOR

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

Interventions

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.

Also known as: Rehabilitation, Physical activity, Endurance, Resistance exercises

Exercise intervention

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.

Control intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Universidade Nove de Julho

São Paulo, São Paulo, 01504-001, Brazil

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Motor Activity

Interventions

Exercise; Rehabilitation

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Fernanda Corrêa, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raphael Ritti-Dias, PhD

CONTACT

+55 19 99940 6878; raphaelritti@gmail.com

Fernanda Corrêa, PhD

CONTACT

+55 11 97344-0380; fecorrea@uninove.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be blinded for the group of the subjects
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 13, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After the publication of the main articles of the study.
• Access Criteria: Upon reasonable request

Locations

BR (1)