Status:
RECRUITING
Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome After COVID-19
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Post-COVID Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The Post-COVID syndrome is a COVID-19 sequelae disease with high individual burden. We conduct a prospective, two-arm, randomized-controlled intervention study with embedded qualitative and physiologi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06004362
Start Date
September 4 2023
End Date
December 1 2025
Last Update
January 23 2024
Active Locations (1)
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1
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Berlin, Germany, 14109