COVID-19, Post-COVID-19 Syndrome
Conditions
Keywords
post COVID-19, sequelae, chronic fatigue
Brief summary
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.
Detailed description
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.
Interventions
OTHERself- 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.
BEHAVIORALadvice literature with naturopathy
advice literature with naturopathic remedies will be handed out and application will be supported with dairies and phone calls
Sponsors
Karl and Veronica Carstens Foundation
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Prospective, randomised controlled, confirmatory intervention study with mixed methods approach
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 Physical Function subscale | week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ5D (EuroQoL 5 domains) | week 8 and 16 | disease specific QoL |
| SF36 PFS (Short Form 36 physical function subscale) | week 16 | changes in the mean score of the SF-36 Physical Function subscale- assessing the degree of fatigue |
| Chalder Fatigue-Scale | week 8 and 16 | Fatigue severity |
| VAS physical resilience (visual analogue scale) | week 8 and 16 | visual analogue scale for subjective physical resilience |
| PHQ9 (Patient Health Questionnaire 9) | week 8 and 16 | Patient Health Questionnaire assessing depression |
| qualitative substudy | week 8 and 16 | interviews regarding experience of illness and therapy |
| hand grip strength | week 8 and 16 | hand grip strength |
| Spirometry | week 8 and 16 | forced expiratory volume |
| autonomic dysfunction orthostasis test | week 8 and 16 | heart rate and blood pressure analysis in orthostasis |
| d2- test | week 8 and 16 | test for concentration- ability to focus |
| VAS pain (visual analogue scale) | week 8 and 16 | visual analogue scale for subjective pain |
Countries
Germany
Contacts
Primary ContactJoanna Dietzel, MD
Backup ContactMiriam Ortiz, MD
Outcome results
None listed