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|Fatigue Syndrome, Chronic NIH
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There are 5 clinical trials
Chronic fatigue is the most common and debilitating symptom in intensive care unit (ICU) survivors. Indeed, it has been widely reported that patients who stayed in ICU for prolonged periods report a feeling of tiredness for months to years after ICU discharge. This symptom seems particularly pronounced in Covid-19 patients and may affect their quality of life by decreasing their capacity to perform simple tasks of daily life. The aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in the feeling of fatigue of Covid-19 patients. Because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. A better knowledge of chronic fatigue etiology and its recovery will allow to optimize rehabilitation treatments to shorten the persistence of chronic fatigue and in fine improve life quality.
Description: Level of cortical activation and cortico-spinal excitability measured by transcranial magnetic stimulationMeasure: Neuromuscular function : cortical activity Time: 6 weeks post-discharge
Description: Peripheral function by electrical nerve stimulationMeasure: Neuromuscular function : Peripheral function Time: 6 weeks post-discharge
Description: measured by effort testMeasure: Maximal oxygen uptake (VO2max) Time: 6 weeks post-discharge
Description: measured by actigraphyMeasure: quality of sleep Time: 6 weeks post-discharge
Description: with Magnetic resonance imagingMeasure: muscle volume Time: 6 weeks post-discharge
Description: measured by a Phosphorus 31 Nuclear magnetic resonance testMeasure: metabolic fatigue Time: 6 weeks post-discharge
Hundreds of thousands of confirmed cases have been reported worldwide, just 3 months after the first patients were identified in Wuhan, China. Just like other members of the community, MS patients are uncomfortable with the emotional distress and health anxiety caused by the COVID-19 outbreak. Most MS patients receive immunosuppressive or immunomodulatory therapies. Patients taking immunosuppressive agents are theoretically at increased risk of being affected by viral pandemics, and a higher health concern is expected in this group of patients. Moreover, MS patients lose social support. Patients with increased duration of stay can no longer access physical and cognitive rehabilitation therapies. We also know that increased anxiety and sleep disorders can cause MS patients to have an attack. When literature is examined, it is known that MS patients' physical activity levels decrease, fatigue, sleep quality and anxiety levels increase, so their quality of life and participation in daily life activities decrease. MS patients lose social support during the COVID-19 outbreak. For all these reasons, we think that the fatigue, physical activity level, anxiety level and sleep disturbances affected before the COVID-19 outbreak will be further affected for these reasons.
Description: Fatigue was assessed by the Fatigue Severity Scale (FSS). This is a 9-item questionnaire that assesses the effect of fatigue on daily living. Each item is a statement on fatigue that the subject rates from 1 "completely disagree" to 7 "completely agree". A score of 4 or higher generally indicates severe fatigueMeasure: Fatigue Time: 4 week
Description: Physical activity levels were assessed by the International Physical Activity Questionnaire (IPAQ): short form. The online self-reporting questionnaire consisted of questions investigating the respondents' PA practice in terms of frequencies and durations of sitting, walking, moderate-intensity physical activities and vigorous-intensity physical activities. The MET-minutes per week (MET-min/week) were calculated using the following formula: intensity (MET) x duration x frequency. Physical activity levels were classified as physically inactive (<600 MET-min/week), with low levels of physical activity (600-3000 MET- min/week) and physical activity level that is sufficient (> 3000 MET-min/week)Measure: Physical activity Time: 4 week
Description: The Pittsburgh Sleep Quality Index (PSQI) questionnaire was used to measure sleep quality using an 18-item scale containing seven items that included sleep quality, sleep duration, sleep latency, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction. Each dimension scored between 0-3, with a total score ranging from 0-21, and a higher score indicating lower sleep quality.Measure: Sleep quality Time: 4 week
Description: The Hospital Anxiety and Depression Scale (HADS) was composed by two subscales (i.e., anxiety and depression), with 7-items each. The anxiety part of HADS was used to evaluate the anxiety levels of the patients. Each dimension scored between 0-3, with a total score ranging from 0-21, and a higher score indicating higher anxiety level.Measure: Anxiety Time: 4 week
We will conduct a double arm, randomized, double-blinded placebo controlled trial of oxaloacetate for treatment of fatigue in women with a history of COVID-19 infection, resolution of the infection, and remaining fatigue that interfere with everyday activities, based on use of a standardized questionnaire to screen for impairment. Participants will receive a 6-week supply of the active or placebo and will be asked to take one capsule twice a day with water and food. They will be contacted weekly for two weeks by the study coordinator to assess for any side effects or difficulty taking the medication. They will be asked to again to complete the standardized questionnaire to screen for impairment after 2 weeks, and again at the end of the study at 6 weeks. Finally, any adverse reactions and symptoms will be evaluated once again four weeks later to ensure that any symptoms that may have been present during treatment have resolved.
Description: Evaluation of self-reported Fatigue with the Fatigue Questionnaire (FQ)Measure: Fatigue Time: 6 weeks
Description: Evaluation of self-reported Fatigue with the Fatigue Severity Scale (FSS)Measure: Fatigue Time: 6 weeks
Description: Evaluation of self-reported depression with Beck's Depression Inventory (BDI)Measure: Depression Time: 6 weeks
This study aims to evaluate the effectiveness of respiratory muscle training with COVID-19 patient, who has underlying health conditions, in order to delay or prevent them from admitting to ICU.
Description: Changes in Respiratory muscle performance will be determined by using the Respiratory Pressure Meter device. Patient will perform full inspiration through this device for 1.5 seconds via the mouth (nose occluded). The reading of the negative peak pressure that is maintained for 1 second in the device is a maximal inspiration peak.Measure: Changes in Respiratory muscle performance Time: Baseline, 1st week, 2nd week, one month
Description: Blood pressure measured by electronic BP machine before and after sessionMeasure: Blood pressure Time: Daily from baseline to hospital discharge (2 weeks)
Description: measured by heart rate monitor before and after sessionMeasure: Heart rate Time: Daily from baseline to hospital discharge (2 weeks)
Description: Measured by pulse oximeter before and after sessionMeasure: Oxygen saturation Time: Daily from baseline to hospital discharge (2 weeks)
Description: Number of % of oxygen patient on it before and after sessionMeasure: Oxygen supplementation Time: Daily from baseline to hospital discharge (2 weeks).
Description: measuring the number of time where the oxygen above or below 4L/min.Measure: Oxygen flow rate Time: Daily from baseline to hospital discharge (2 weeks)
Description: By using Borg scale (rating of perceived exertion scale), Possible score range from 0 (nothing) to 10 ( Maximal exertion). Before and after session.Measure: Dyspnoea level Time: Daily from baseline to hospital discharge (2 weeks)
Description: By using visual analogue scale. Possible score range from 0 (no pain) to 10 (worst possible pain) Before and after session.Measure: Pain level Time: Daily from baseline to hospital discharge (2 weeks)
Description: Measured by Respiratory rate monitor. Before and after sessionMeasure: Respiratory rate Time: Daily from baseline to hospital discharge (2 weeks)
Description: Recording number for breath and sets daily.Measure: Threshold IMT device Time: Daily from baseline to 1 month from admission
Recent studies show that patients who have contracted COVID-19 retain very significant fatigue after resolving the infectious episode. This fatigue may be explained by low-grade inflammation. There is more data for patients with COVID-19 who have been hospitalized than for non-hospitalized patients with milder forms. However, COVID-19 related fatigue would not only affect elderly people with severe cardiopulmonary consequences but also young subjects without severities. This notion is not very widespread and to date, COVID contracted by young subjects is considered to have very few consequences on their health. It is also known that the prevalence of sleep debt is significant in the general population and particularly in young people, and it is also known that sleep deprivation increases low-grade inflammation and facilitates the risk of viral contamination. The association between sleep deprivation, drowsiness and possibly low-grade inflammation raise questions about the mechanisms of fatigue in the general population. Investigators are also entitled to wonder to what extent the chronic sleep debt suffered by the French population can explain an increased risk of contamination by COVID 19 but also significant residual fatigue after COVID infection. Bordeaux University Hospital screens 2,000 subjects per day at risk of being infected by COVID, it would be very interesting to measure, in a population of young adults aged 18-45 years, frequently exposed to a sleep debt, sleep hygiene (bedtime and wake-up times, sleep and wake-up schedules, and overall sleep satisfaction), average sleep duration, level of fatigue and drowsiness and to compare these thresholds between subjects with or without COVID 19 according to nasopharyngeal PCR.
Description: Presence of significant fatigue as measured by the Fatigue Severity Scale (FSS) at 1 month. Score from 1 to 7 FSS is a 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score is 9 and maximum score possible is 63. Higher is the score, greater is the fatigue severityMeasure: Fatigue Severity Scale Time: one month after inclusion (T0)
Description: Diagnosis of COVID-19 by nasopharyngeal PCRMeasure: COVID Diagnosis Time: inclusion (T0)
Description: Fatigue measured by Fatigue Severity Scale FSS is a 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score is 9 and maximum score possible is 63. Higher is the score, greater is the fatigue severityMeasure: Fatigue evolution Time: Inclusion (T0) and one month after
Description: Sleep hygiene measured with questionnaireMeasure: Sleep hygiene Time: Inclusion (T0) and one month after
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports