NCT05725538

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

Efficacy of Exercise-based mHealth Intervention for Patients With Post-acute COVID-19 Syndrome Based on Fatigue, Fitness, Post-exertional Dyspnea, Pain, Anxiety, Depression, Cognitive Function, and Quality of Life: a Randomized Clinical Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Cadiz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Post-Acute COVID19 Syndrome
• Long COVID
• Post COVID-19 Condition

Interventions

Type	Name	Description
DEVICE	COVIDReApp Group	The COVIDReApp group will be required to complete an exercise program guided by an m-health system for three times per week during 24 weeks. A 60-minute program, following the recommendations of the American College of Sports Medicine. The daily session will be divided into: * Warm-up: 5 min. walking so that the patient can hold a conversation , monopodial balance exercise, core exercise and other respiratory and joint mobility exercises. * Aerobic training: Walking for 10 to 20 min. so that the patient can maintain a conversation, but having to stop to breathe from time to time. * Strengthening: It will focus on 7 exercises. a) squats, b) dead weight with stiff legs, c) lateral pull-ups, d) inverted flies, e) flies, f) unilateral rowing and g) lateral raises. * Cool down: It will consist of stretching exercises. a) shoulders, b) triceps, c) chest, d) quadriceps, e) hamstrings, and f) back.
OTHER	Control Group	Participants will receive the same intervention in the traditional way, they will receive the exercise program in paper format. They will receive a document with photos and descriptions of the exercises to be performed. Their doctors will determine if the patients will be able to exercise regularly and they will perform them for 24 weeks.

Timeline

• Start date: 2023-03-15
• Primary completion: 2024-03-15
• Completion: 2024-09-15
• First posted: 2023-02-13
• Last updated: 2023-02-13

Locations

1 site across 1 country: Spain