The clinical trial aims to analyse the effectiveness of a physiotherapeutic exerciseprogram delivered through the telerehabilitation tool (Trak) compared to a booklet-basedrehabilitation format in post-COVID-19 patients.This research seeks to provide insights into the acceptance of the TRAK tool in thisspecific population, contributing to the advancement of understanding in this field.Participants will be assigned to either the control group, which will receiveconventional rehabilitation, or the experimental group, which will undergotelerehabilitation. Both groups will undergo a 6-week physical intervention, with pre-and post-intervention evaluations.Researchers will compare the control and experimental groups to determine if there aresignificant differences in the health conditions of each group.
The study recruitment process targets individuals who have experienced COVID-19 (moderate
or severe), regardless of whether they required hospital admission, and who necessitate
rehabilitation post-disease and have been discharged from quarantine.
After initial screening, individuals meeting predefined inclusion criteria will be
invited to participate. Before enrollment, written informed consent will be obtained from
all participants to ensure ethical compliance and respect for individual autonomy.
The primary evaluation variable selected for the study is functional capacity.
Additionally, secondary assessments will include measurements of muscle strength,
subjective perception of exertion, heart rate, oxygen saturation, lung capacity, and
adherence to treatment (only in the experimental group).
The study cohort will comprise patients randomly assigned to experimental or control
groups.
Only patients in the experimental group will receive an email containing access to the
TRAK platform as part of the informed consent process. Here, they will conduct their
treatment. Initial and final assessments will be performed using a digital Case Report
Form for the control and experimental groups.
A rehabilitation doctor will determine the exercise protocol prescribed to the patient,
which physiotherapists will administer via TRAK (experimental group) or in-person format
(control group).
Patients in the experimental group will use TRAK six weeks for rehabilitation, following
a prescribed exercise protocol prepared by a rehabilitation doctor. Conversely,
individuals in the control group will adhere to instructions and guidelines provided by
healthcare personnel during the same duration.
The study will employ an intention-to-treat analysis approach, incorporating all
participants into the final analysis, regardless of their adherence to the intervention
protocol.
Other: Trak exercise prescription protocol
Online treatment based on therapeutic exercise using the Trak software. The patient will
undergo 6 weeks of an exercise prescription protocol based on strength, balance,
proprioception, and aerobic exercises. Physical therapy techniques to improve secretion
management and respiratory mechanics will also be included.
Other: Conventional rehabilitation plan in the gym
Treatment is based on therapeutic exercise following a conventional rehabilitation plan.
The patient will undergo 6 weeks of an exercise prescription protocol based on strength,
balance, proprioception, and aerobic exercises. Physical therapy techniques will also be
included to improve secretion management and respiratory mechanics.
Inclusion Criteria:
- Patients that have suffered COVID-19 [COVID-19-moderate: clinical signs of pneumonia
(fever, cough, dyspnea, tachypnea), but without signs of severe pneumonia,
particularly oxygen saturation greater than or equal to 90% with air atmosphere;
COVID-19-severe: clinical signs of pneumonia (fever, cough, dyspnea, tachypnea) plus
one of the following: frequency respiratory > 30 inspirations/min; severe dyspnea;
treatment oral medication.]
- Patients with COVID-19-related muscle pain.
- Patients with a personal device such as a tablet, smartphone, or laptop operate
agilely with these devices.
- Patients with email.
- Signing of the informed consent.
Exclusion Criteria:
- Patients with a resting heart rate higher than 110 beats per minute.
- Patients with blood pressure less than 90/60 or over 160/95.
- Patients with lower blood oxygen saturation of 90%.
- Patients with advanced cognitive impairment.
Asunción Klinika
Tolosa 3108008, Gipuzkoa, Spain
María A García Velázquez, Principal Investigator
Asunción Klinika