Clinical trial NCT06492551: Post-COVID-19 Patients With Trak Tool
Official title: Prospective Clinical Trial of Trak Tool Usage in Post-COVID-19 Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post COVID-19 Condition
Keywords: telemedicine
COVID-19
digital health
telerehabilitation
physiotherapy
exercise program
Lead sponsor: Trak Health Solutions S.L.
Sponsor class: INDUSTRY
First posted: 2024-07-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Barthel index
timeFrame: Baseline; up to 6 weeks
Secondary outcomes:
measure: Resting heart rate
timeFrame: Baseline; up to 6 weeks
measure: Lung capacity
timeFrame: Baseline; up to 6 weeks
measure: Oxygen saturation
timeFrame: Baseline; up to 6 weeks
measure: Borg scale
timeFrame: Baseline; up to 6 weeks
measure: Daniels scale
timeFrame: Baseline; up to 6 weeks
measure: Trak satisfaction questionnaire
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Tolosa
country: Spain
facility: Asunción Klinika
state: Gipuzkoa
Study officials:
affiliation: Asunción Klinika
name: María A García Velázquez
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Zhao HM, Xie YX, Wang C; Chinese Association of Rehabilitation Medicine; Respiratory Rehabilitation Committee of Chinese Association of Rehabilitation Medicine; Cardiopulmonary Rehabilitation Group of Chinese Society of Physical Medicine and Rehabilitation. Recommendations for respiratory rehabilitation in adults with coronavirus disease 2019. Chin Med J (Engl). 2020 Jul;133(13):1595-1602. doi: 10.1097/CM9.0000000000000848. No abstract available.
citation: Vitacca M, Malovini A, Balbi B, Aliani M, Cirio S, Spanevello A, Fracchia C, Maniscalco M, Corica G, Ambrosino N, Paneroni M. Minimal Clinically Important Difference in Barthel Index Dyspnea in Patients with COPD. Int J Chron Obstruct Pulmon Dis. 2020 Oct 21;15:2591-2599. doi: 10.2147/COPD.S266243. eCollection 2020.
citation: Thomas P, Baldwin C, Bissett B, Boden I, Gosselink R, Granger CL, Hodgson C, Jones AY, Kho ME, Moses R, Ntoumenopoulos G, Parry SM, Patman S, van der Lee L. Physiotherapy management for COVID-19 in the acute hospital setting: clinical practice recommendations. J Physiother. 2020 Apr;66(2):73-82. doi: 10.1016/j.jphys.2020.03.011. Epub 2020 Mar 30.
citation: Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, Evaluation, and Treatment of Coronavirus (COVID-19). 2023 Aug 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/