Acupressure and Qigong in Chronic Fatigue Post COVID-19.

NCT05289154 | Unknown

• 1 other identifier: ACUQiG
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Post-COVID-19 Syndrome

Keywords

post COVID-19, sequelae, chronic fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• EQ5D (EuroQoL 5 domains)

  week 8 and 16

• SF36 PFS (Short Form 36 physical function subscale)

  week 16

• Chalder Fatigue-Scale

  week 8 and 16

• VAS physical resilience (visual analogue scale)

  week 8 and 16

• PHQ9 (Patient Health Questionnaire 9)

  week 8 and 16

Study Arms (2)

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.

Other: self- applied acupressure plus Qigong course plus advice literature

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.

Behavioral: advice literature with naturopathy

Interventions

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.

self- applied acupressure plus Qigong plus advice literature

advice literature with naturopathy BEHAVIORAL

advice literature with naturopathic remedies will be handed out and application will be supported with dairies and phone calls

advice literature

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosis of chronic fatigue (after SARS-CoV2 infection)
• 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.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Karl and Veronica Carstens Foundation: collaborator

Study Sites (1)

Charité Universitätsmedizin Campus Mitte

Berlin, 10117, Germany

RECRUITING

Related Publications (7)

• 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.

  PMID: 33273026 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.

  PMID: 32644129 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.

  PMID: 31607352 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.

  PMID: 20617920 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.

  PMID: 3295732 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.

  PMID: 2092449 BACKGROUND

• 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.

  PMID: 40727709 DERIVED

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Naturopathy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Benno Brinkhaus, PhD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomised controlled, confirmatory intervention study with mixed methods approach

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 21, 2022
• Study Start: June 14, 2022
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)