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

NCT05725538 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-02-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Cadiz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2024-03-15
Completion
2024-09-15

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05725538 on ClinicalTrials.gov