Acupressure and Qigong in Chronic Fatigue Post COVID-19. (ACUQiG)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Post-COVID-19 Syndrome
• Intervention / Treatment: Other: self- applied acupressure plus Qigong course plus advice literature; Behavioral: advice literature with naturopathy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joanna Dietzel, MD; Phone Number: +49 30 450 529 002; Email: joanna.dietzel@charite.de
• Study Contact Backup: Name: Miriam Ortiz, MD; Phone Number: +49 30 450 529 002; Email: miriam.ortiz@charite.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité Universitätsmedizin Campus Mitte
    • Contact: Benno Brinkhaus, MD, PhD; Phone Number: +49 30 450 529 002; Email: benno.brinkhaus@charite.de
    • Contact: Joanna Dietzel, MD; Phone Number: +49 30 450 529 005; Email: joanna.dietzel@charite.de
    • Sub-Investigator: Joanna Dietzel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: 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.	Behavioral: advice literature with naturopathy; advice literature with naturopathic remedies will be handed out and application will be supported with dairies and phone calls

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Karl and Veronica Carstens Foundation
• Investigators: Principal Investigator: Benno Brinkhaus, PhD, Charite University, Berlin, Germany

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: post COVID-19, sequelae, chronic fatigue
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Fatigue
• Other Study ID Numbers: ACUQiG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No