Chronic exhaustion or fatigue in the context of a post-covid illness
Conditions
Interventions
Group 1: Intervention: Outpatient supervised immersive neuromuscular training (12 sessions of 45 minutes each over 6 weeks) with 1:1-supervision based on a novel VR training device, which is based on
Sponsors
Klinik für Allgemeine Innere Medizin und Psychosomatik des Universitätsklinikums Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) meet the WHO definition for Post-Covid according to the WHO Case Definition 2021 2) have fatigue symptoms that (i) occurred during the course of the COVID-19 infection and that either persist with symptom onset after the acute COVID-19 or its treatment, or that occur after the end of the acute phase but can be understood as a consequence of the SARS-CoV-2 infection (ii) have at least moderate severity, defined as an FSS-value of 36 or higher 3) agree to participate in the study by written informed consent 4) be capable of giving consent
Exclusion criteria
Exclusion criteria: 1) ICU stay since first COVID-19 infection 2) need for more intensive medical management (e.g., grade 4 PCFS or severe comorbidities) 3) pre-existing medical conditions that are also associated with fatigue and by which the fatigue can be better explained than by Post-COVID syndrome (e.g. recurrent depressive disorder, ME/CFS) 3) inability to participate due to comorbid neurological or musculoskeletal conditions that result in moderate to severe physical disability or that would militate against VR exposure (eg. vertigo, significant hearing and/or visual impairment) 4) severe cognitive impairment or dementia 5) known pregnancy 6) insufficient German language skills 7) participation in another COVID interventional study (observational studies are allowed) 8) weight over 130kg (because the Icaros device is not suitable for patients with a higher weight) 9) inability to reach the study location by using the staircase to the first floor (to ensure a minimal level of physical fitness)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in change in fatigue, measured on the Fatigue Severity Scale (FSS) between groups from baseline (T0) to the post-treatment assessment (T1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-Covid-Scale of functional status (PCSF), Post-exertional malaise (DSQ-PEM), Hospital anxiety and depression scale (HADS), Quality of life (EQ-5D 5L, SF-12) Burden of somatic complaints (Somatic Symptom Disorder (SSD-12), Somatic-Symptom-Scale (SSS8)), Jenkins-Sleep-Scale (JSS), Exercise vital sign, Pain (Multidimensional Pain-Inventory (MPI-D), Pain-drawings), Handgrip-strength test, 6min-walk test, Trail-Making-Test (TMT), Stroop-Test, N-back-Test, Digit span-Test Patients global impression of change (PGIC), Therapistst global impression of change (TGIC), Adverse Events (duration, type, severity) | — |
Countries
Germany
Contacts
Public ContactJonas Tesarz
Klinik für Allgemeine Innere Medizin und Psychosomatik des Universitätsklinikums Heidelberg
Outcome results
None listed