Post COVID-19 Condition
Conditions
Keywords
telemedicine, COVID-19, digital health, telerehabilitation, physiotherapy, exercise program
Brief summary
The clinical trial aims to analyse the effectiveness of a physiotherapeutic exercise program delivered through the telerehabilitation tool (Trak) compared to a booklet-based rehabilitation format in post-COVID-19 patients. This research seeks to provide insights into the acceptance of the TRAK tool in this specific population, contributing to the advancement of understanding in this field. Participants will be assigned to either the control group, which will receive conventional rehabilitation, or the experimental group, which will undergo telerehabilitation. 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 are significant differences in the health conditions of each group.
Detailed description
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.
Interventions
OTHERTrak 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.
OTHERConventional 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.
Sponsors
Trak Health Solutions S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Barthel index | Baseline; up to 6 weeks | It assesses daily activities in patients with musculoskeletal or neuromuscular conditions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung capacity | Baseline; up to 6 weeks | It is measured by spirometry. It measures the volume of air exhaled at specific time points during complete exhalation by force, which is preceded by a maximal inhalation. |
| Oxygen saturation | Baseline; up to 6 weeks | A measure of how much haemoglobin is currently bound to oxygen compared to how much is not. It is measured with a finger pulse oximeter. |
| Resting heart rate | Baseline; up to 6 weeks | It is the number of times the heart beats per minute at rest, which can be an important sign of heart health. |
| Daniels scale | Baseline; up to 6 weeks | It measures the patient's strength in a specific movement and muscle from 0 to 5, with 0 indicating total paralysis and 5 indicating the entire joint movement with resistance. |
| Trak satisfaction questionnaire | Up to 6 weeks | The Trak satisfaction questionnaire, which was provided to patients in Spanish, consists of 12 questions about usability, usefulness, and satisfaction, as well as a suggestions section at the end. |
| Borg scale | Baseline; up to 6 weeks | Numerical scale that ranges from 6 to 20, where 6 means no exertion at all and 20 means maximal exertion. |
Countries
Spain
Outcome results
None listed