SARS-CoV-2 InfectionCOPERIA-REHABNCT05629884
Efficacy of a Physical and Respiratory Rehabilitation Program for Patients With Persistent COVID-19 (SARS-CoV-2).
A study testing COPERIA-REHAB in people with SARS-CoV-2 Infection and COVID-19 Recurrent, run by Fundacin Biomedica Galicia Sur at 4 sites in Spain.
Trial summary
The pandemic caused by SARS-CoV-2 infection has resulted, in addition to the well-known acute symptoms, in the emergence of a plethora of persistent, diffuse and heterogeneous symptoms such as fatigue, shortness of breath and cognitive dysfunction among others, that have come to be called persistent COVID. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Infection, COVID-19 Recurrent, Cognitive Dysfunction
- What is being tested?
- COPERIA-REHAB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 4 sitesSpain
- Study dates
- 14 Dec 2022to 14 Nov 2023
- 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
- Age ≥18 and ≤70 years of age.
- Patients with a diagnosis according to WHO criteria of persistent COVID-19 until 03/28/2022
- Patients with a Post Covid Functional Status (PCFS) ≥ 2.
- Patients who present a need for physical rehabilitation and agree to perform it.
- Patients with capacity to consent and who agree to participate in the study.
- Patients who know how to use Smartphone and/or Tablet and have at least one of these devices.
- Patients who have access to the rehabilitation tools at home or are willing to go to the gyms proposed in the study to perform the rehabilitation exercises.
Who cannot join
- Minors or persons judicially incapacitated.
- Previous neurological or psychiatric pathology involving neuropsychological compromise.
- Active Covid19 infection.
- Home oxygen therapy > 16 hours or home Cpap- Bipap.
- Previous diagnosis of arrhythmia or blockage.
- Previous coronary pathology.
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- Decompensated renal or metabolic disease.
- Signs or symptoms of unknown cardiac disease.
- Undergoing another physical or cognitive rehabilitation process at the time of inclusion.
- Patients who do not agree to participate in the study.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Complexo Hospitalario Universitario de Ourense
Ourense, 32002
Alejandro García Caballero, MD, alejandro.alberto.garcia.caballero@sergas.es
Alejandro García Caballero, MD
S.S. Computer Engineering (University of Vigo)
Ourense, 32004
Xose Antón Vila Sobrino, PhD
Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36213
Beatriz Calderón Cruz, PhD
School of Telecommunication Engineering (University of Vigo)
Vigo, Pontevedra, 36310
Carmen García Mateo, PhD
About this study
Official title: Efficacy of a Physical and Respiratory Rehabilitation Program (COPERIA-REHAB) for Patients With Persistent COVID-19 (SARS-CoV-2).
The pandemic caused by SARS-CoV-2 infection has resulted, in addition to the well-known acute symptoms, in the emergence of a plethora of persistent, diffuse and heterogeneous symptoms such as fatigue, shortness of breath and cognitive dysfunction among others, that have come to be called persistent COVID. Patients have reported that physical activity, stress and sleep disturbances often trigger exacerbations of their symptoms related by some authors to the so-called Post Exertional Malaise (PEM) characteristic of Myalgic Encephalomyelitis. Similarly, by analogy with other pathologies, it has been hypothesized that optimal exercise prescription would benefit these people with persistent COVID-19 symptoms but in practice, the rehabilitation of these patients runs the risk of collapsing respiratory and physical rehabilitation services.
This is why COPERIA proposes the construction of a platform for respiratory, cardiac and muscular telerehabilitation, to compare with face-to-face rehabilitation treatment and to try to predict the influence of physical activity in the prediction of PEM.
- Being tested
- COPERIA-REHAB
- Keywords
- COVID-19, SARS-CoV-2, Persistent Covid, Cardiac rehabilitation, Respiratory rehabilitation, Physical rehabilitation
- Medical subject headings
- COVID-19, Cognitive Dysfunction, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPERIA-REHABOther
After the randomization of the patient there will be some preliminary sessions where the means of self-monitoring training and the Borg 1/10 effort scale will be explained and training videos will be shown. Doubts will also be answered.
Afterwards, training will start through the COPERIA-REHAB platform, which will last 8 weeks (6 days per week).
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | This group will perform the rehabilitation from home or from the gym following online instructions in the COPERIA platform. Receives: Other: COPERIA-REHAB |
| Control arm | No intervention | This control arm will train at the rehabilitation service or at home following the instructions provided by the rehabilitation service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six Minutes Walking test
The 6-min walk test is a standard in cardiac rehabilitation, serving both to ecologically determine the patient's functional status and to make recommendations regarding the intensity of rehabilitative exercise. The patient is asked to run the maximum distance he/she can in 6 minutes. The length of one of the hospital corridors has been previously measured so that by counting the number of times the patient walks the distance covered is determined. In addition to the number of meters, the heart rate is monitored by means of a pectoral band, and the saturation level by means of a pulse oximeter; the BP is evaluated before and after the test. In the context of functional assessment of Persistent COVID, it has been used for the evaluation of the impact of rehabilitation measures.
Measured: 8 weeks
Secondary outcomes (6)
mMRC dyspnea scale
The MRC shortness of breath scale consists of five statements that describe almost the entire range of respiratory disability, from none (Grade 1) to almost complete disability (Grade 5). It can be self-administered by asking subjects to choose the statement that best describes their condition, e.g., "'I am only short of breath with strenuous exertion" (Grade 1) or "I am so short of breath that I cannot leave the house" (Grade 5). Alternatively, it can be administered by an interviewer asking the questions, such as "Are you short of breath when rushing on level ground or when climbing a gentle slope?" (Grade 2). The score is the number that best matches the patient's activity level.
Measured: 8 weeks
SF-36 Health Questionnaire
The SF-36 Health Questionnaire is composed of 36 items that assess both positive and negative states of health. The 36 items of the instrument cover the following scales: Physical Function, Physical Role, Bodily Pain, General Health, Vitality, Social Function, Emotional Role, and Mental Health. Additionally, the SF-36 includes a transition item that asks about the change in general health status from the previous year.
Measured: 8 weeks
Maximal Handgrip Strenght
Handgrip strength (HGS) is measured by a handgrip dynamometer and is considered an indicator of overall muscle strength. Low muscle strength, also known as dynapenia is an important indicator of health status, as well as an indicator of sarcopenia. Maximal grip strength is determined by performing three grip attempts at maximum power.
Measured: 8 weeks
1 Minute Sit to Stand test
Consists of sitting down and getting up from a chair without resting the hands as many times as possible for 1 minute with the patient connected to the saturator and monitored with a chest strap. The minute is timed, the number of repetitions performed is counted, the oxygen saturation value and heart rate are observed and the patient waits 1 minute after the exercise to record again the recovery of the basal parameters.
Measured: 8 weeks
P maximal inspiratory and P maximal expiratory
These tests will be performed by the Pneumology Service. The measurement of maximal inspiratory and expiratory pressures are well tolerated and relatively easy to perform, they allow estimating the neuromuscular function of the diaphragm, as well as the abdominal, intercostal and accessory muscles. In general terms, the Pimax test estimates the strength of inspiratory muscles (diaphragm) and the Pemax test estimates the strength of abdominal and intercostal muscles. The tests consist of the patient having to generate maximum inspiratory and expiratory pressures against an occluded mouthpiece.
Measured: 8 weeks
Insomnia Severity Index.
This instrument for the assessment of insomnia consists of 7 questions that are rated between 0 and 4 points. It evaluates both the insomnia of conciliation, maintenance and early awakening, as well as its functional repercussions during the day.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start14 Dec 2022 (estimated)
- Primary completion14 Nov 2023 (estimated)
- Study completion14 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacin Biomedica Galicia Sur
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vigo, Galician South Health Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629884
- Sponsor's protocol ID
- COPERIA-REHAB
- Acronym
- COPERIA-REHAB
- Status last verified
- Nov 2022
- First submitted
- 18 Nov 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Physical and Respiratory Rehabilitation Program (COPERIA-REHAB) for Patients With Persistent COVID-19 (SARS-CoV-2).
- ClinicalTrials.gov ID
- NCT05629884
- Acronym / sponsor ID
- COPERIA-REHAB / COPERIA-REHAB
- Keywords
- COVID-19, SARS-CoV-2, Persistent Covid, Cardiac rehabilitation, Respiratory rehabilitation, Physical rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Fundacin Biomedica Galicia SurUniversity, hospital or other
- Collaborators
- University of Vigo, Galician South Health Research Institute
- Study start
- 14 Dec 2022 (estimated)
- Primary completion
- 14 Nov 2023 (estimated)
- Study completion
- 14 Nov 2023 (estimated)
- First posted
- 29 Nov 2022 (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 pandemic caused by SARS-CoV-2 infection has resulted, in addition to the well-known acute symptoms, in the emergence of a plethora of persistent, diffuse and heterogeneous symptoms such as fatigue, shortness of breath and cognitive dysfunction among others, that have come to be called persistent COVID. Patients have reported that physical activity, stress and sleep disturbances often trigger exacerbations of their symptoms related by some authors to the so-called Post Exertional Malaise (PEM) characteristic of Myalgic Encephalomyelitis. Similarly, by analogy with other pathologies, it has been hypothesized that optimal exercise prescription would benefit these people with persistent COVID-19 symptoms but in practice, the rehabilitation of these patients runs the risk of collapsing respiratory and physical rehabilitation services.
This is why COPERIA proposes the construction of a platform for respiratory, cardiac and muscular telerehabilitation, to compare with face-to-face rehabilitation treatment and to try to predict the influence of physical activity in the prediction of PEM.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Other: COPERIA-REHABThis group will perform the rehabilitation from home or from the gym following online instructions in the COPERIA platform. |
| Control arm | No intervention | –This control arm will train at the rehabilitation service or at home following the instructions provided by the rehabilitation service. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 and ≤70 years of age.
- Patients with a diagnosis according to WHO criteria of persistent COVID-19 until 03/28/2022
- Patients with a Post Covid Functional Status (PCFS) ≥ 2.
- Patients who present a need for physical rehabilitation and agree to perform it.
- Patients with capacity to consent and who agree to participate in the study.
Key exclusion criteria (10 listed)
- Minors or persons judicially incapacitated.
- Previous neurological or psychiatric pathology involving neuropsychological compromise.
- Active Covid19 infection.
- Home oxygen therapy > 16 hours or home Cpap- Bipap.
- Previous diagnosis of arrhythmia or blockage.
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 |
|---|---|---|
| COPERIA-REHABAfter the randomization of the patient there will be some preliminary sessions where the means of self-monitoring training and the Borg 1/10 effort scale will be explained and training videos will be shown. Doubts will also be answered. Afterwards, training will start through the COPERIA-REHAB platform, which will last 8 weeks (6 days per week). | Other | Experimental arm |
Primary outcome
Six Minutes Walking test
Time frame: 8 weeks
The 6-min walk test is a standard in cardiac rehabilitation, serving both to ecologically determine the patient's functional status and to make recommendations regarding the intensity of rehabilitative exercise. The patient is asked to run the maximum distance he/she can in 6 minutes. The length of one of the hospital corridors has been previously measured so that by counting the number of times the patient walks the distance covered is determined. In addition to the number of meters, the heart rate is monitored by means of a pectoral band, and the saturation level by means of a pulse oximeter; the BP is evaluated before and after the test. In the context of functional assessment of Persistent COVID, it has been used for the evaluation of the impact of rehabilitation measures.
6 secondary outcomes
mMRC dyspnea scale
Time frame: 8 weeks
SF-36 Health Questionnaire
Time frame: 8 weeks
Maximal Handgrip Strenght
Time frame: 8 weeks
1 Minute Sit to Stand test
Time frame: 8 weeks
P maximal inspiratory and P maximal expiratory
Time frame: 8 weeks
Insomnia Severity Index.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPERIA-REHAB in people with SARS-CoV-2 Infection and COVID-19 Recurrent, run by Fundacin Biomedica Galicia Sur at 4 sites 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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro García Caballero, MD (988 38 55 00, alejandro.alberto.garcia.caballero@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six Minutes Walking test (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2022.