Post-COVID-19 Patients With Trak Tool

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-16

Study Completion Date

2022-10-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post COVID-19 Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental group

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

Group Type EXPERIMENTAL

Trak exercise prescription protocol

Intervention Type OTHER

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.

Control Group

Exercise protocol with conventional methods in the Asunción Klinika gym.

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation plan in the gym

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No