Post-COVID-19 Patients With Trak Tool

NCT06492551 | Completed DMC

• 1 other identifier: PS2022011
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Post COVID-19 Condition

Keywords

telemedicine; COVID-19; digital health; telerehabilitation; physiotherapy; exercise program

Outcome Measures

Primary Outcomes (1)

• Barthel index

  It assesses daily activities in patients with musculoskeletal or neuromuscular conditions.

  Baseline; up to 6 weeks

Secondary Outcomes (6)

• Resting heart rate

  Baseline; up to 6 weeks

• Lung capacity

  Baseline; up to 6 weeks

• Oxygen saturation

  Baseline; up to 6 weeks

• Borg scale

  Baseline; up to 6 weeks

• Daniels scale

  Baseline; up to 6 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Other: Trak exercise prescription protocol

Control Group

ACTIVE COMPARATOR

Exercise protocol with conventional methods in the Asunción Klinika gym.

Other: Conventional rehabilitation plan in the gym

Interventions

Trak exercise prescription protocol 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.

Experimental group

Conventional rehabilitation plan in the gym 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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trak Health Solutions S.L.: lead

Study Sites (1)

Asunción Klinika

Tolosa, Gipuzkoa, 20400, Spain

Location

Related Publications (5)

• Lahham A, McDonald CF, Moore R, Cox NS, Rawlings S, Nichols A, Liacos A, Holland AE. The impact of home-based pulmonary rehabilitation on people with mild chronic obstructive pulmonary disease: A randomised controlled trial. Clin Respir J. 2020 Apr;14(4):335-344. doi: 10.1111/crj.13138. Epub 2020 Jan 11.

  PMID: 31880078 BACKGROUND

• 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.

  PMID: 32251002 BACKGROUND

• 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.

  PMID: 33116476 BACKGROUND

• 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.

  PMID: 32312646 BACKGROUND

• 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/

  PMID: 32150360 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• María A García Velázquez

  Asunción Klinika

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 9, 2024
• Study Start: March 16, 2022
• Primary Completion: September 23, 2022
• Study Completion: October 5, 2022
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

ES (1)