Clinical trial NCT05289154: Acupressure and Qigong in Chronic Fatigue Post COVID-19.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Post-COVID-19 Syndrome
Keywords: post COVID-19, sequelae, chronic fatigue
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Karl and Veronica Carstens Foundation
First posted: 2022-03-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomised controlled, confirmatory intervention study with mixed methods approach
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: SF-36 Physical Function subscale
timeFrame: week 8
Secondary outcomes:
measure: EQ5D (EuroQoL 5 domains)
timeFrame: week 8 and 16
measure: SF36 PFS (Short Form 36 physical function subscale)
timeFrame: week 16
measure: Chalder Fatigue-Scale
timeFrame: week 8 and 16
measure: VAS physical resilience (visual analogue scale)
timeFrame: week 8 and 16
measure: PHQ9 (Patient Health Questionnaire 9)
timeFrame: week 8 and 16
measure: VAS pain (visual analogue scale)
timeFrame: week 8 and 16
measure: hand grip strength
timeFrame: week 8 and 16
measure: Spirometry
timeFrame: week 8 and 16
measure: autonomic dysfunction orthostasis test
timeFrame: week 8 and 16
measure: d2- test
timeFrame: week 8 and 16
measure: qualitative substudy
timeFrame: week 8 and 16
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Campus Mitte
Study officials:
affiliation: Charite University, Berlin, Germany
name: Benno Brinkhaus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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