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

July 8, 2024 updated by: Trak Health Solutions S.L.

Prospective Clinical Trial of Trak Tool Usage in Post-COVID-19 Patients.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Gipuzkoa
      • Tolosa, Gipuzkoa, Spain, 20400
        • Asunción Klinika

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Exercise protocol to be performed through Trak. Trak is a rehabilitation tool and, therefore, the product of investigation.
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.
Active Comparator: Control Group
Exercise protocol with conventional methods in the Asunción Klinika gym.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel index
Time Frame: Baseline; up to 6 weeks
It assesses daily activities in patients with musculoskeletal or neuromuscular conditions.
Baseline; up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting heart rate
Time Frame: 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.
Baseline; up to 6 weeks
Lung capacity
Time Frame: 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.
Baseline; up to 6 weeks
Oxygen saturation
Time Frame: 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.
Baseline; up to 6 weeks
Borg scale
Time Frame: 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".
Baseline; up to 6 weeks
Daniels scale
Time Frame: 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.
Baseline; up to 6 weeks
Trak satisfaction questionnaire
Time Frame: 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.
Up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trak Health Solutions S.L.

Investigators

  • Principal Investigator: María A García Velázquez, Asunción Klinika

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2022

Primary Completion (Actual)

September 23, 2022

Study Completion (Actual)

October 5, 2022

Study Registration Dates

First Submitted

July 4, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2024

Last Update Submitted That Met QC Criteria

July 8, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS2022011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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