Acupressure and Qigong in Chronic Fatigue Post COVID-19.

Study Overview
=================
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.

Official Title
-----------------
Self- Applied Acupressure and Online Qigong for Patients Suffering From Chronic Fatigue After Corona Virus Infection 19 (COVID-19) - a Randomized Controlled Mixed-methods Study.

Conditions
-----------------
COVID-19, Post-COVID-19 Syndrome

Intervention / Treatment
-----------------
* Other: self- applied acupressure plus Qigong course plus advice literature
* Behavioral: advice literature with naturopathy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of chronic fatigue (after SARS-CoV2 infection) 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. acute SARS-CoV2 infection at least 12 weeks ago age 18-60 years visual analogue scale (0-100 mm) physical resilience of maximum 60 mm SF-36 physical function of maximum 65 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 written informed consent available. Exclusion Criteria: fatigue already present before the SARS-CoV2 infection other underlying diseases leading to symptoms of chronic fatigue, such as major depression, oncological diseases, multiple sclerosis, fibromyalgia and drug abuse other serious underlying diseases, such as severe pulmonary, cardiac, psychiatric or infectious diseases, which could interfere with study participation or affect the results ongoing opioid therapy or opioid therapy in the week prior to study entry chronic use of cannabinoids before or during the study. start of psychotherapy or interruption of ongoing therapy during study participation female participants: pregnancy or breastfeeding participation in another clinical intervention study during study participation ongoing pension procedure or planned claiming of a pension procedure due to disability planned inpatient rehabilitation measures during study participation due to PostCOVID-19 -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomised controlled, confirmatory intervention study with mixed methods approach
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: self- applied acupressure plus Qigong plus advice literature<br>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. | Other: self- applied acupressure plus Qigong course plus advice literature<br>* daily self applied acupressure over 20min plus 2 times per week online live Qigong course of each 45min- both over 8 weeks.<br>|
| Active Comparator: advice literature<br>advice literature contains naturopathic remedies such as application of massage-oils, use of herbal teas, meditation techniques, breathing exercises for reconvalescence after COVID19. | Behavioral: advice literature with naturopathy<br>* advice literature with naturopathic remedies will be handed out and application will be supported with dairies and phone calls<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post COVID-19, sequelae, chronic fatigue