Self-Applied Acupressure and Online Qigong for Chronic Fatigue Post Covid19 (ACUQiG) - Design and Methods of a Randomized Controlled Trial
by Theresa Bauer1, Miriam Ortiz1, Judith Bellmann-Strobl2,6, Ute Engelhardt4, Rainer Nögel4, Josef Hummelsberger4, Andreas Michalsen1, Stephanie Roll1, Weronika Grabowska1, Barbara Stöckigt1, Hosnya Karim1, Anna Mietzner5, Carmen Scheibenbogen2, Stefan N. Willich1, Friedemann Paul3,6, Benno Brinkhaus1, Joanna Dietzel1*
1Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charitéplatz 1, 10117 Berlin, Germany
2Institute of Medical Immunology, Charité - Universitätsmedizin Berlin, Germany
3NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin, Germany
4International Society for Chinese Medicine (SMS), Munich, Germany
5TCM-Praxis-Mietzner, Seelingstr. 32, 14059 Berlin, Germany
6Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecular Medicine in the Helmholtz Association and Charité - Universitätsmedizin Berlin, Germany
*Corresponding Authors: Joanna Dietzel, Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Luisenstr. 57, 10117 Berlin, Germany.
Received Date: 3 November 2023
Accepted Date: 9 November 2023
Published Date: 13 November 2023
Citation: Bauer T, Ortiz M, Bellmann-Strobl J, Engelhardt U, Nögel R, et al. (2023) Self-Applied Acupressure and Online Qigong for Chronic Fatigue Post Covid19 (ACUQiG) - Design and Methods of a Randomized Controlled Trial. Curr Res Cmpl Alt Med 7: 214. https://doi.org/10.29011/2577-2201.100214
Abstract
Background: Observational studies confirm the high incidence of postCOVID-19-syndrome (PCS) after infection with SARSCOV2, which can occur in 10-15% of all infected person. A substantial percentage of PCS patients convert into Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS). The aim of this study is to investigate effects of a combined therapy of acupressure and Qigong on parameters of fatigue in patients with PCS. Methods: ACUQiG is an open, two-arm randomized controlled single center trial with mixed methods approach. The intervention group (n=100) receive a daily self-massage of selected acupressure points over 8 weeks and follow twice weekly a live online Qigong course over 8 weeks whereas the control group (n=100) is a waiting-group. All patients continue routine care and receive advice on Complementary and Alternative Medicine (CAM). The primary outcome will be the change in the physical function subscale from the SF-36 at week 8. Secondary outcomes at week 8 and week 16: fatigue severity, post-exertional-malaise severity, disease-related quality of life, depressiveness, headache, sleep quality, hand grip strength, lung function, heart rate analysis during orthostasis, and neurocognitive outcomes regarding concentration and attention. A nested qualitative study will be performed with 10 - 12 patients about subjective experiences of the disease and the expectations, experiences and perceived effects of the interventions. Expected Outcomes: The results of this study will show if patients with PCS could benefit from a combined therapeutic intervention consisting of selfapplied acupressure and Qigong when added to routine care and CAM advice.
Trial registration: Clinicaltrial.gov identifier: NCT05289154, https://clinicaltrials.gov/ct2/show/NCT05289154. First registered 21.03.2022.
Keywords: Chronic fatigue; Post COVID syndrome; Long COVID; Acupressure; Qigong; Randomized controlled trial; COVID-19
Abbreviations
ACUQiG- Trial: Acupressure and Qigong for PCS; AE: Adverse Event; ANCOVA: Analysis of Covariance; CAM: Complementary and Alternative Medicine; CCC: Canadian Consensus Criteria; CFQ: Chalder Fatigue Questionnaire; CM: Chinese Medicine; DMC: Data Monitoring Committee; DSQPEM: DePaul Symptom Questionnaire – Post Exertional Malaise; EQ-5D-5L: Questionnaire “disease-related quality of life”; FAS: Full Analysis Set; FEV: Forced Expiratory Volume; FVC: Forced Vital Capacity; ITT: Intention-To-Treat; MCID: Minimal Clinically Important Difference; ME/CFS: Myalgic Encephalomyelitis / Chronic Fatigue Syndrome; PCS: Post COVID Syndrome; PEM: Post Exertional Malaise; PGIC: Patients’ Global Impression of Change; PHQ-9: Patient Health Questionnaire 9; POTS: Postural Tachycardia Syndrome; PSQI: Pittsburgh Sleep Quality Index; SAE: Severe Adverse Event; SAP: Statistical Analysis Plan; SF36: Short Form 36; VAS: Visual Analogue Scale.