International observational studies confirm the high incidence of post-infectiousresidual 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 theseverity of the acute infection. Post corona virus disease 19 (postCOVID-19) patientssuffer mostly from symptoms such as fatigue, muscle pain, problems to focus, depressionand sleep disturbances.So far, there are no results of interventional studies for the treatment of chronicfatigue post COVID-19, but there are indicators that post COVID-19 syndrome is a chronicsubclinical inflammation, similar to Chronic Fatigue Syndrome / Myalgic EncephalomyelitisCSF/ME, which also often develops from a postviral syndrome. Previously tested andeffective strategies for the treatment of chronic fatigue syndrome / myalgicencephalomyelitis (CFS/ME) will be tested in the treatment of chronic fatiguepostCOVID-19, in this randomized controlled trial a combination of acupressure andQigong.The aim of this project is to evaluate an acupressure treatment plus a Qigong exerciseseries specifically tailored for chronic fatigue postCOVID-19 , used daily by thepatients themselves and regularly supervised, in comparison to the advice literature onthe 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.
Other: self- applied acupressure plus Qigong course plus advice literature
daily self applied acupressure over 20min plus 2 times per week online live Qigong course
of each 45min- both over 8 weeks.
Behavioral: advice literature with naturopathy
advice literature with naturopathic remedies will be handed out and application will be
supported with dairies and phone calls
Inclusion Criteria:
1. diagnosis of chronic fatigue (after SARS-CoV2 infection)
2. with at least 3 of 7 criteria at time of study inclusion: sleeping disorder,
headaches, joint pain/muscle pain, anxiety/depression, memory impairment/
concentration problems, anosmia, exercise intolerance.
3. acute SARS-CoV2 infection at least 12 weeks ago
4. age 18-60 years
5. visual analogue scale (0-100 mm) physical resilience of maximum 60 mm
6. SF-36 physical function of maximum 65
7. technically equipped to participate in the online intervention and willing to follow
the study procedure, acupressure and Qigong to perform the exercise series at home
8. written informed consent available.
Exclusion Criteria:
1. fatigue already present before the SARS-CoV2 infection
2. other underlying diseases leading to symptoms of chronic fatigue, such as major
depression, oncological diseases, multiple sclerosis, fibromyalgia and drug abuse
3. other serious underlying diseases, such as severe pulmonary, cardiac, psychiatric or
infectious diseases, which could interfere with study participation or affect the
results
4. ongoing opioid therapy or opioid therapy in the week prior to study entry
5. chronic use of cannabinoids before or during the study.
6. start of psychotherapy or interruption of ongoing therapy during study participation
7. female participants: pregnancy or breastfeeding
8. participation in another clinical intervention study during study participation
9. ongoing pension procedure or planned claiming of a pension procedure due to
disability
10. planned inpatient rehabilitation measures during study participation due to
PostCOVID-19 -
Charité Universitätsmedizin Campus Mitte
Berlin, Germany
Investigator: Benno Brinkhaus, MD, PhD
Contact: +49 30 450 529 002
benno.brinkhaus@charite.de
Investigator: Joanna Dietzel, MD
Joanna Dietzel, MD
+49 30 450 529 002
joanna.dietzel@charite.de
Miriam Ortiz, MD
+49 30 450 529 002
miriam.ortiz@charite.de
Benno Brinkhaus, PhD, Principal Investigator
Charite University, Berlin, Germany