International observational studies confirm the high incidence of post-infectious residual syndrome after infection with severe acute respiratory syndrome corona virus 2 (SARS-COV2), which can occur in 10-15% of all infected persons, regardless of the severity of the acute infection. Post corona virus disease 19 (postCOVID-19) patients suffer mostly from symptoms such as fatigue, muscle pain, problems to focus, depression and sleep disturbances. So far, there are no results of interventional studies for the treatment of chronic fatigue post COVID-19, but there are indicators that post COVID-19 syndrome is a chronic subclinical inflammation, similar to Chronic Fatigue Syndrome / Myalgic Encephalomyelitis CSF/ME, which also often develops from a postviral syndrome. Previously tested and effective strategies for the treatment of chronic fatigue syndrome / myalgic encephalomyelitis (CFS/ME) will be tested in the treatment of chronic fatigue postCOVID-19, in this randomized controlled trial a combination of acupressure and Qigong. The aim of this project is to evaluate an acupressure treatment plus a Qigong exercise series specifically tailored for chronic fatigue postCOVID-19 , used daily by the patients themselves and regularly supervised, in comparison to the advice literature on the treatment of PostCOVID-19 syndrome alone.
Prospective two-arm (parallel groups) randomised controlled confirmatory intervention study with mixed methods approach in 2x 100 patients (n=200). Intervention: self-applied acupressure and online Qigong course over 8 weeks and follow up at week 16. Group 1: Acupressure + Qigong: Massage of the points daily for 3 minutes per point with the finger or an acupuncture pen (some points can be massaged bilaterally, therefore total approx. 20 min). In addition, twice a week an online guided Qigong course with a duration of 30-45 min. The patients should practise Qigong at least 3 times a week (including the course date). In addition, all patients will receive the guidebook literature for the treatment of complaints after SARS-CoV2 infection. Group 2: Patients will receive advice literature on the treatment of chronic fatigue after SARS-CoV2 infection. After the end of this study the patients of this group will receive written information and video material regarding the acupressure and Qigong exercises.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
daily self applied acupressure over 20min plus 2 times per week online live Qigong course of each 45min- both over 8 weeks.
advice literature with naturopathic remedies will be handed out and application will be supported with dairies and phone calls
Charité Universitätsmedizin Campus Mitte
Berlin, Germany
RECRUITINGSF-36 Physical Function subscale
Primary study objective is to assess the changes in the mean score of the SF-36 Physical Function subscale between the two study arms assessing the degree of fatigue.
Time frame: week 8
EQ5D (EuroQoL 5 domains)
disease specific QoL
Time frame: week 8 and 16
SF36 PFS (Short Form 36 physical function subscale)
changes in the mean score of the SF-36 Physical Function subscale- assessing the degree of fatigue
Time frame: week 16
Chalder Fatigue-Scale
Fatigue severity
Time frame: week 8 and 16
VAS physical resilience (visual analogue scale)
visual analogue scale for subjective physical resilience
Time frame: week 8 and 16
PHQ9 (Patient Health Questionnaire 9)
Patient Health Questionnaire assessing depression
Time frame: week 8 and 16
VAS pain (visual analogue scale)
visual analogue scale for subjective pain
Time frame: week 8 and 16
hand grip strength
hand grip strength
Time frame: week 8 and 16
Spirometry
forced expiratory volume
Time frame: week 8 and 16
autonomic dysfunction orthostasis test
heart rate and blood pressure analysis in orthostasis
Time frame: week 8 and 16
d2- test
test for concentration- ability to focus
Time frame: week 8 and 16
qualitative substudy
interviews regarding experience of illness and therapy
Time frame: week 8 and 16
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