Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome After COVID-19

Last updated: January 22, 2024
Sponsor: Charite University, Berlin, Germany
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

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

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 physiological sub-studies in a mixed-methods design.

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
    Germany

    Active - Recruiting

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