The Post-COVID syndrome is a COVID-19 sequelae disease with high individual burden. Weconduct a prospective, two-arm, randomized-controlled intervention study with embeddedqualitative and physiological sub-studies in a mixed-methods design.
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Behavioral: Complementary and Integrative Medicine online intervention, routine care and book
The online program takes place in a multiprofessionally guided online group setting once
a week for up to 180 minutes (including several breaks) over a period of 10 weeks:
- Basic principles of a plant-based whole-food nutrition
- Procedures of hydrotherapy according to Kneipp
- Self-help strategies (e.g. teas, wraps, compresses etc.)
- Methods of mind-body medicine (mindfulness, meditation, breathing, yoga etc.)
- Methods of extended Complementary and Integrative Medicine (e.g. acupressure)
It is recommended to practice a part of the taught exercises at home for about 30 minutes
daily. In addition, the patients receive a book for the treatment of post-covid syndrome
complaints. Group 1 additionally uses the already existing routine care (e.g. general
practitioner).
Behavioral: Routine care and book
Participants in the second study arm receive routine care, e.g. from their general
practitioner. In addition, the patients receive the same book as group 1 for the
treatment of post-covid syndrome complaints. The participants of the second study arm
will be offered to participate in the Complementary and Integrative Medicine online
intervention after 4 months within the study.
Inclusion criteria:
- Acute SARS-CoV2 infection at least 12 weeks ago (documented by PCR test results or
SARS-CoV-2 antibodies)
- History of chronic fatigue (after SARS-CoV-2 infection)
- At least 3 of 7 criteria fulfilled at the time of inclusion: sleep disturbance,
headache, joint pain/muscle pain, anxiety/depression, memory
impairment/concentration disturbance, postexertional malaise, dysosmia/anosmia
- Numerical Rating Scale (NRS, 0-10 points, 0 = not able to exercise at all; 10 = full
exercise capacity) physical exercise capacity of max. 6 points ("What is your
physical exercise capacity on average over the last 7 days?")
- Short Form-36 Physical Function Subscale (SF-36 PFS) of maximum 65 points
- Patient are technically equipped enough to participate in the online intervention
and willing to follow the study procedure to perform the online intervention at home
Exclusion criteria:
- Fatigue already present before SARS-CoV-2 infection
- Presence of severe post-exertional malaise (PEM) (according to DSQ-PEM tool question
7 OR 8 with yes AND >14h condition worsening)
- Other underlying conditions leading to symptoms of chronic fatigue, such as unstable
mental illness, oncological disease(s), MS, fibromyalgia, and substance abuse
- Other serious underlying medical conditions, such as severe pulmonary, cardiac,
psychiatric, or infectious diseases that could interfere with study participation or
affect results • Ongoing opioid therapy or opioid therapy in the week prior to study
entry
- Regular use of cannabinoids or other illicit drugs in the month prior to or during
the study
- Restarting or discontinuing psychotherapy during study participation in the 6 weeks
prior to study entry
- Pregnancy or breastfeeding
- Participation in another clinical intervention study during study participation 1
- Regular use of Complementary and Integrative Medicine self-help measures (e.g.
meditation, Kneipp hydrotherapiy, etc.) within the study period
- Current pension procedure or planned claiming of a pension procedure due to
disability
- Planned rehabilitation measures during study participation due to post-COVID
syndrome
Inclusion and exclusion criteria of the sub-study focus group interviews with physicians
Inclusion criteria:
- Family physicians and general practitioners
- Regular outpatient care of patients with post-covid syndrome
- Willingness in principle to participate in a 2-hour interview on-site or online
Exclusion criteria:
• No previous care of post-covid patients
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Berlin, Germany
Investigator: Miriam Rösner, Study nurse
Contact: 00493080505682
naturheilkunde.studien@immanuel.de
Investigator: Andreas Michalsen, Prof. Dr.
Miriam Rösner
004980505682
naturheilkunde.studien@immanuel.de
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