Last updated: January 22, 2024
Sponsor: Charite University, Berlin, Germany
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
Routine care and book
Complementary and Integrative Medicine online intervention, routine care and book
Clinical Study ID
NCT06004362
NHKOnline
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
- Acute SARS-CoV2 infection at least 12 weeks ago (documented by PCR test results orSARS-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/concentrationdisturbance, postexertional malaise, dysosmia/anosmia
- Numerical Rating Scale (NRS, 0-10 points, 0 = not able to exercise at all; 10 = fullexercise capacity) physical exercise capacity of max. 6 points ("What is your physicalexercise 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 andwilling to follow the study procedure to perform the online intervention at home
Exclusion
Exclusion criteria:
- Fatigue already present before SARS-CoV-2 infection
- Presence of severe post-exertional malaise (PEM) (according to DSQ-PEM tool question 7OR 8 with yes AND >14h condition worsening)
- Other underlying conditions leading to symptoms of chronic fatigue, such as unstablemental 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 oraffect results • Ongoing opioid therapy or opioid therapy in the week prior to studyentry
- Regular use of cannabinoids or other illicit drugs in the month prior to or during thestudy
- Restarting or discontinuing psychotherapy during study participation in the 6 weeksprior 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
Study Design
Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Routine care and book
Phase:
Study Start date:
September 04, 2023
Estimated Completion Date:
December 31, 2025
Connect with a study center
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Berlin, 14109
GermanyActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.