Acupressure and Qigong in Chronic Fatigue Post COVID-19.

NCT ID: NCT05289154

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-14
• Study Completion Date: 2023-10-01

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.

Conditions

COVID-19; Post-COVID-19 Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

self- applied acupressure plus Qigong plus advice literature

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.

Group Type: EXPERIMENTAL

self- applied acupressure plus Qigong course plus advice literature

Intervention Type: OTHER

daily self applied acupressure over 20min plus 2 times per week online live Qigong course of each 45min- both over 8 weeks.

advice literature

advice literature contains naturopathic remedies such as application of massage-oils, use of herbal teas, meditation techniques, breathing exercises for reconvalescence after COVID19.

Group Type: ACTIVE_COMPARATOR

advice literature with naturopathy

Intervention Type: BEHAVIORAL

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

Interventions

self- 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.

Intervention Type: OTHER

advice literature with naturopathy

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

Intervention Type: BEHAVIORAL

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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karl and Veronica Carstens Foundation

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Benno Brinkhaus

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benno Brinkhaus, PhD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charité Universitätsmedizin Campus Mitte

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Joanna Dietzel, MD

Role: CONTACT

joanna.dietzel@charite.de

+49 30 450 529 002

Miriam Ortiz, MD

Role: CONTACT

miriam.ortiz@charite.de

+49 30 450 529 002

Facility Contacts

Benno Brinkhaus, MD, PhD

Role: primary

benno.brinkhaus@charite.de

+49 30 450 529 002

Joanna Dietzel, MD

Role: backup

joanna.dietzel@charite.de

+49 30 450 529 005

References

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.

Reference Type: BACKGROUND

PMID: 33273026 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32644129 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31607352 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20617920 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3295732 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2092449 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40727709 (View on PubMed)

Other Identifiers

ACUQiG

Identifier Type: -

Identifier Source: org_study_id