Post COVID-19 ConditionTRAK-COVIDNCT06492551
Post-COVID-19 Patients With Trak Tool
A study testing Trak exercise prescription protocol and Conventional rehabilitation plan in the gym in people with Post COVID-19 Condition, run by Trak Health Solutions S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post COVID-19 Condition
- What is being tested?
- Trak exercise prescription protocol and Conventional rehabilitation plan in the gym
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 16 Mar 2022to 5 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Post COVID-19 Condition
- Being tested
- Trak exercise prescription protocol, Conventional rehabilitation plan in the gym
- Keywords
- telemedicine, COVID-19, digital health, telerehabilitation, physiotherapy, exercise program
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trak exercise prescription protocolOther
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.
Conventional rehabilitation plan in the gymOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Exercise protocol to be performed through Trak. Trak is a rehabilitation tool and, therefore, the product of investigation. Receives: Other: Trak exercise prescription protocol |
| Control Group | Active comparator | Exercise protocol with conventional methods in the Asunción Klinika gym. Receives: Other: Conventional rehabilitation plan in the gym |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel index
It assesses daily activities in patients with musculoskeletal or neuromuscular conditions.
Measured: Baseline; up to 6 weeks
Secondary outcomes (6)
Resting heart rate
It is the number of times the heart beats per minute at rest, which can be an important sign of heart health.
Measured: Baseline; up to 6 weeks
Lung capacity
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.
Measured: Baseline; up to 6 weeks
Oxygen saturation
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.
Measured: Baseline; up to 6 weeks
Borg scale
Numerical scale that ranges from 6 to 20, where 6 means "no exertion at all" and 20 means "maximal exertion".
Measured: Baseline; up to 6 weeks
Daniels scale
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.
Measured: Baseline; up to 6 weeks
Trak satisfaction questionnaire
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.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start16 Mar 2022
- Primary completion23 Sep 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post COVID-19 ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trak Health Solutions S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- María A García Velázquez, Principal investigator, Asunción Klinika
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492551
- Sponsor's protocol ID
- PS2022011
- Acronym
- TRAK-COVID
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31880078Zhao 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.
PubMed 32251002Vitacca 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.
PubMed 33116476Thomas 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.
PubMed 32312646Cascella 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; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/
PubMed 32150360
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trial of Trak Tool Usage in Post-COVID-19 Patients.
- ClinicalTrials.gov ID
- NCT06492551
- Acronym / sponsor ID
- TRAK-COVID / PS2022011
- Conditions
- Post COVID-19 Condition
- Keywords
- telemedicine, COVID-19, digital health, telerehabilitation, physiotherapy, exercise program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Trak Health Solutions S.L.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Trak exercise prescription protocolExercise protocol to be performed through Trak. Trak is a rehabilitation tool and, therefore, the product of investigation. |
| Control Group | Active comparator | Other: Conventional rehabilitation plan in the gymExercise protocol with conventional methods in the Asunción Klinika gym. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trak exercise prescription protocolOnline 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. | Other | Experimental group |
| Conventional rehabilitation plan in the gymTreatment 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. | Other | Control Group |
Primary outcome
Barthel index
Time frame: Baseline; up to 6 weeks
It assesses daily activities in patients with musculoskeletal or neuromuscular conditions.
6 secondary outcomes
Resting heart rate
Time frame: Baseline; up to 6 weeks
Lung capacity
Time frame: Baseline; up to 6 weeks
Oxygen saturation
Time frame: Baseline; up to 6 weeks
Borg scale
Time frame: Baseline; up to 6 weeks
Daniels scale
Time frame: Baseline; up to 6 weeks
Trak satisfaction questionnaire
Time frame: Up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Background: PubMed 31880078Lahham 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.
- Background: PubMed 32251002Zhao 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.
- Background: PubMed 33116476Vitacca 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.
- Background: PubMed 32312646Thomas 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.
- Background: PubMed 32150360Cascella 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; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María A García Velázquez principal investigator
Asunción Klinika
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trak exercise prescription protocol and Conventional rehabilitation plan in the gym in people with Post COVID-19 Condition, run by Trak Health Solutions S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel index (time frame: Baseline; up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06492551, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024; AzTrials last refreshed its copy on 30 Oct 2026.