Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Karl and Veronica Carstens Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| self- applied acupressure plus Qigong plus advice literature | Experimental | daily 20 min of self- applied acupressure over 8 weeks on acupuncture points Yintang, LI4, Pe6, ST36, SP6 and depending on further symptoms plus DU23/24 in hyposmia, LU7 in dyspnoea, GB34 in pain conditions, GB20 in headache OR Anmian in sleeping disorders. The 16 sessions of 45 min Qigong course over 8 weeks will contain live online guided exercises with breathing, stretching and tapping of meridians and exercises such as the crane exercise. |
|
| advice literature | Active Comparator | advice literature contains naturopathic remedies such as application of massage-oils, use of herbal teas, meditation techniques, breathing exercises for reconvalescence after COVID19. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| self- applied acupressure plus Qigong course plus advice literature | Other | daily self applied acupressure over 20min plus 2 times per week online live Qigong course of each 45min- both over 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| SF-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. | week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| EQ5D (EuroQoL 5 domains) | disease specific QoL | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joanna Dietzel, MD | Contact | +49 30 450 529 002 | joanna.dietzel@charite.de | |
| Miriam Ortiz, MD | Contact | +49 30 450 529 002 | miriam.ortiz@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Benno Brinkhaus, PhD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Universitätsmedizin Campus Mitte | Recruiting | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33273026 | Background | Arnold DT, Hamilton FW, Milne A, Morley AJ, Viner J, Attwood M, Noel A, Gunning S, Hatrick J, Hamilton S, Elvers KT, Hyams C, Bibby A, Moran E, Adamali HI, Dodd JW, Maskell NA, Barratt SL. Patient outcomes after hospitalisation with COVID-19 and implications for follow-up: results from a prospective UK cohort. Thorax. 2021 Apr;76(4):399-401. doi: 10.1136/thoraxjnl-2020-216086. Epub 2020 Dec 3. | |
| 32644129 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D009324 | Naturopathy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
Prospective, randomised controlled, confirmatory intervention study with mixed methods approach
Not provided
Not provided
Not provided
| advice literature with naturopathy | Behavioral | advice literature with naturopathic remedies will be handed out and application will be supported with dairies and phone calls |
|
| week 16 |
| Chalder Fatigue-Scale | Fatigue severity | week 8 and 16 |
| VAS physical resilience (visual analogue scale) | visual analogue scale for subjective physical resilience | week 8 and 16 |
| PHQ9 (Patient Health Questionnaire 9) | Patient Health Questionnaire assessing depression | week 8 and 16 |
| VAS pain (visual analogue scale) | visual analogue scale for subjective pain | week 8 and 16 |
| hand grip strength | hand grip strength | week 8 and 16 |
| Spirometry | forced expiratory volume | week 8 and 16 |
| autonomic dysfunction orthostasis test | heart rate and blood pressure analysis in orthostasis | week 8 and 16 |
| d2- test | test for concentration- ability to focus | week 8 and 16 |
| qualitative substudy | interviews regarding experience of illness and therapy | week 8 and 16 |
| Background |
| Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603. |
| 31607352 | Background | Chan JSM, Ng SM, Yuen LP, Chan CLW. Qigong exercise for chronic fatigue syndrome. Int Rev Neurobiol. 2019;147:121-153. doi: 10.1016/bs.irn.2019.08.002. |
| 20617920 | Background | Jason L, Brown M, Evans M, Anderson V, Lerch A, Brown A, Hunnell J, Porter N. Measuring substantial reductions in functioning in patients with chronic fatigue syndrome. Disabil Rehabil. 2011;33(7):589-98. doi: 10.3109/09638288.2010.503256. Epub 2010 Jul 9. |
| 3295732 | Background | Glasier CM, Seibert JJ, Williamson SL, Seibert RW, Corbitt SL, Rodgers AB, Lange TA. High resolution ultrasound characterization of soft tissue masses in children. Pediatr Radiol. 1987;17(3):233-7. doi: 10.1007/BF02388167. |
| 2092449 | Background | Weyand CM, Goronzy JJ. The role of infectious agents in the etiopathogenesis of chronic rheumatic diseases. Verh Dtsch Ges Inn Med. 1990;96:319-24. doi: 10.1007/978-3-642-84317-4_58. No abstract available. |
| 40727709 | Derived | Bauer T, Grabowska W, Ortiz M, Bellmann-Strobl J, Engelhardt U, Nogel R, Hummelsberger J, Michalsen A, Roll S, Stockigt B, Batram H, Mietzner A, Scheibenbogen C, Willich SN, Paul F, Brinkhaus B, Dietzel J. Self-medication and off-label prescribing in post COVID-19 syndrome: Baseline data of a randomized acupressure and qigong trial. Integr Med Res. 2025 Sep;14(3):101197. doi: 10.1016/j.imr.2025.101197. Epub 2025 Jul 5. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |