Efficacy of a Physical and Respiratory Rehabilitation Program for Patients With Persistent COVID-19 (SARS-CoV-2).

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of a Physical and Respiratory Rehabilitation Program (COPERIA-REHAB) for Patients With Persistent COVID-19 (SARS-CoV-2).

Conditions
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SARS-CoV-2 Infection, COVID-19 Recurrent, Cognitive Dysfunction, Fatigue

Intervention / Treatment
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* Other: COPERIA-REHAB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>This group will perform the rehabilitation from home or from the gym following online instructions in the COPERIA platform. | Other: COPERIA-REHAB<br>* 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).<br>|
| No Intervention: Control arm<br>This control arm will train at the rehabilitation service or at home following the instructions provided by the rehabilitation service. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, SARS-CoV-2, Persistent Covid, Cardiac rehabilitation, Respiratory rehabilitation, Physical rehabilitation