Post-COVID-19 Patients With Trak Tool (TRAK-COVID)

Trak Health Solutions S.L.

Status: Completed

Conditions: Post COVID-19 Condition

Treatments: Other: Trak exercise prescription protocol; Other: Conventional rehabilitation plan in the gym

Study type: Interventional

Funder types: Industry

Identifiers

NCT06492551

PS2022011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Experimental group

Experimental group

Description:

Exercise protocol to be performed through Trak. Trak is a rehabilitation tool and, therefore, the product of investigation.

Treatment:

Other: Trak exercise prescription protocol

Control Group

Active Comparator group

Description:

Exercise protocol with conventional methods in the Asunción Klinika gym.

Treatment:

Other: Conventional rehabilitation plan in the gym