Clinical trial NCT06168006: Exercise Training Using an App on Physical Cardiovascular Function Individuals With Post-covid-19 Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Acute COVID-19 Syndrome
Keywords: exercise
mobile app
physical function
cardiovascular function
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in 6 min-walk test distance at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline in Glittre test at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline in sit and stand test at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline in Post-Covid Functional Scale at 12 weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change from baseline in Patient Functional Scale at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline in Motor Evoked Potential at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline in Modified Medical Research Dyspnea Scale at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline in Chalder Physical Fatigue Scale at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline in De Paul Symptom Questionnaire at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline in Quality of Life at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline in Frailty and Sarcopenia at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline in Anxiety and Depressive Symptoms at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline in Pain at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline in Movement Behavior at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline in Barriers to Physical activity at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Post assessment of Exercise Adherence Assessment Scale
timeFrame: 12 weeks
measure: Change from baseline in Blood Pressure at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline in Cardiac Autonomic Modulation at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline in Blood Flow and Flow-mediated Dilation at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change in Spirometry parameters at 12 weeks
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: System Usability Scale
timeFrame: 12 weeks
measure: The User Experience Questionnaire
timeFrame: 12 weeks
measure: Focal group
timeFrame: 12 weeks
Locations:
city: São Paulo
country: Brazil
facility: Universidade Nove de Julho
Study officials:
affiliation: University of Nove de Julho
name: Fernanda Corrêa, PhD
role: PRINCIPAL_INVESTIGATOR
References: