Exercise Intervention Using mHealth in Patients With Post-Acute COVID-19 Syndrome: a Randomized Clinical Trial (COVIDReApp)

University of Cadiz

Status: Enrolling

Conditions: Post COVID-19 Condition; Long COVID; Post-Acute COVID19 Syndrome

Treatments: Device: COVIDReApp Group; Other: Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05725538

COVIDReApp

Details and patient eligibility

About

Post-Acute Syndrome COVID-19 is a disease resulting from infection by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is estimated that between 10 and 35% of infected persons suffer symptoms afterwards, and in hospitalized patients it can reach 85%. These sequelae have individual, social and economic repercussions, so effective rehabilitation alternatives are necessary. Physical exercise is recommended as rehabilitation for these patients. Moreover, the implementation of m-Health supported interventions is a proven alternative in patients with Post-Acute COVID-19 Syndrome or other conditions, which improves therapeutic adherence and patient autonomy. Therefore, the development and evaluation of the effectiveness of an exercise-based m-Health system for application in patients with Post-Acute COVID-19 Syndrome responds to a need.

Our hypothesis is that a mobile health technology based on physical exercise recommendations for patients with Post-Acute COVID-19 Syndrome will improve fatigue, physical fitness, post-exertional dyspnea, pain intensity, anxiety, depression, cognitive function, and quality of life. Therefore, this project aims to evaluate the efficacy of the mobile health technology system (COVIDReApp) based on physical exercise recommendations for patients with COVID-19 Post-Acute Syndrome based on its results on fatigue, physical condition, post-exertional dyspnea, pain intensity, anxiety and depression, cognitive function and quality of life.

The achievement of the present project will serve to analyze the benefits of a physical exercise program in patients with COVID-19 Post-Acute Syndrome and identify those patients in whom the benefits will be greatest and whose implementation will have the highest priority.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligible participants will be patients who have had COVID-19 at any time since the onset of the pandemic and even have Acute Post-CoVID-19 Syndrome, identified by their physicians and recruited from routine outpatient appointments at the Post-CoVID-19 Service of the Hospital Universitario Puerta del Mar, Cadiz, Spain.

Their physicians will give them an appointment for a future session in which potential participants will be provided with patient information and the consent form, and will be contacted approximately 48 hours later to discuss their willingness to participate.

Inclusion Criteria:

• Male and female patients.
• Over 18 years of age.
• Absence of cognitive and physical deficits that would preclude physical exercise.
• Owner of a smartphone with Internet access.
• Ability to understand and write in Spanish.

Exclusion criteria:

• Concomitant diseases that prevent physical exercise.
• Contraindications to physical exercise detected by physicians.
• Participation in moderate-intensity activities (more than 30 minutes and 3 times per week) at the time of study initiation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

COVIDReApp Group

Experimental group

Description:

The intervention group will complete a program of exercise guided by a m-health system (COVIDReApp) for 24 weeks.

Treatment:

Device: COVIDReApp Group

Control Group

Active Comparator group

Description:

The comparator group will complete a program of exercise in a traditional way (exercises will be provided in paper format) for 24 weeks.

Treatment:

Other: Control Group