An interventional study of COPERIA-REHAB in SARS-CoV-2 Infection, COVID-19 Recurrent and Cognitive Dysfunction, sponsored by Fundacin Biomedica Galicia Sur. Status unknown at 4 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-29.
Sponsored by Fundacin Biomedica Galicia Sur · Not applicable, Interventional, and Other
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.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's planned enrollment of 56 is below the median of 100 across 4,175 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Fundacin Biomedica Galicia Sur is the lead sponsor of 28 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This group will perform the rehabilitation from home or from the gym following online instructions in the COPERIA platform.
Other: COPERIA-REHAB
This control arm will train at the rehabilitation service or at home following the instructions provided by the rehabilitation service.
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).
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.
Time frame: 8 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
Age
Years
Time frame: 8 weeks
Sex
Male, Female
Time frame: 8 weeks
Body mass index
kg/m\^2
Time frame: 8 weeks
Current treatment
Treatment taken by the patient at the time of the study.
Time frame: 8 weeks
Date of PCR + SARS-CoV-2
DD-MMM-YYYY
Time frame: 8 weeks
Epidemic wave
Of the 7 waves of COVID-19 that have occurred in Spain, a description will be given of the wave to which the infection of each patient included belonged. First, second, third, fourth, fifth, sixth, seventh, eighth, ninth or tenth wave.
Time frame: 8 weeks
Vaccination status at the time of infection
Number of vaccine doses at the time of infection
Time frame: 8 weeks
FVC
Is the maximum volume of air exhaled, with the maximum possible effort, starting from a maximum inspiration in ml.
Time frame: 8 weeks
FEV1
The volume of air expelled during the first second of forced expiration in ml
Time frame: 8 weeks
FEV1/FVC
Expressed as a percentage (%), it indicates the proportion of the FVC that is expelled during the first second of the forced expiratory maneuver.
Time frame: 8 weeks
CO diffusion test
To evaluate the transfer of oxygen from the alveolar space to the hemoglobin of the erythrocytes contained in the pulmonary capillaries. Effective alveolar-capillary area available for gas transfer in the lung. (%)
Time frame: 8 weeks
Start is estimated for Dec 2022; primary completion for Nov 2023, 11 months later.
Of 1,295 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's planned 11 months is close to that.
Counting every sponsor, half of 1,425 studies reached it within 9 months; a quarter within 3 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Fundacin Biomedica Galicia Sur