Clinical trial NCT05725538: Exercise Intervention Using mHealth in Patients With Post-Acute COVID-19 Syndrome: a Randomized Clinical Trial
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Acute COVID19 Syndrome
Long COVID
Post COVID-19 Condition
Keywords: smartphone
mHealth
mobile health
telerehabilitation
exercise
Post-Acute COVID-19 Syndrome
Long COVID
Post-COVID Condition
COVIDReApp
Lead sponsor: University of Cadiz
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 100
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: 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.


Eligibility 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.

Primary outcomes:
measure: Longitudinal Change from Baseline up to 24 Weeks Follow-up in Fatigue (Fatigue Severity Scale (FSS))
timeFrame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
measure: Longitudinal Change from Baseline up to 24 Weeks Follow-up in Post-exertional dyspnoea (Dyspnoea-12)
timeFrame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
measure: Longitudinal Change from Baseline up to 24 Weeks Follow-up in Quality of life (SF-12v2)
timeFrame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
Secondary outcomes:
measure: Longitudinal Change from Baseline up to 24 Weeks Follow-up in Pain intensity (Visual Analog Scale (VAS))
timeFrame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
measure: Longitudinal Change from Baseline up to 24 Weeks Follow-up in Upper limb strength (Arm curl test)
timeFrame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
measure: Longitudinal Change from Baseline up to 24 Weeks Follow-up in Lower limb strength (Chair stand test)
timeFrame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
measure: Longitudinal Change from Baseline up to 24 Weeks Follow-up in Functional capacity and endurance (Two-minute walk test (2MWT))
timeFrame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
measure: Longitudinal Change from Baseline up to 24 Weeks Follow-up in Depression and/or anxiety (Hospital Anxiety and Depression Scale (HADs)
timeFrame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
measure: Longitudinal Change from Baseline up to 24 Weeks Follow-up in Cognitive function (Test Your Memory (TYM))
timeFrame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
measure: Longitudinal Change from Baseline up to 24 Weeks Follow-up in Height, weight, and body mass index
timeFrame: Baseline, 4 weeks post-treatment, 12 weeks post-treatment, and 24 weeks post-treatment.
measure: Baseline of sociodemographic variables
timeFrame: Baseline.
measure: Daily registry of the exercise difficulty (Borg Rating of Perceived Exertion Scale (RPE))
timeFrame: Only CovidReApp group: Daily.
measure: Daily registry of the adherence (CovidReApp log registration and self-reported)
timeFrame: Daily.
Other outcomes:
Locations:
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
Study officials:
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