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

NCT06004362 | Unknown

• 1 other identifier: NHKOnline
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 physiological sub-studies in a mixed-methods design.

Conditions

Post-COVID Syndrome

Outcome Measures

Primary Outcomes (1)

• Short Form 36 (SF-36), Physical Functioning Scale

  The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.

  Baseline, 10 weeks

Secondary Outcomes (19)

• Short Form 36 (SF-36)

  Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks

• DePaul Post-Exertional Malaise Questionnaire (DSQ-PEM)

  Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks

• Post-COVID-Syndrom (PCS) Score

  Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks

• Chalder Fatigue Scale (CFS)

  Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks

• Quality of life (EQ-5D-5L)

  Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks

Other Outcomes (3)

• Qualitative data

  Week 10

• Sub-study: Focus group interviews with physicians

  Week 10

• Sub-study: biosignal characteristics

  Baseline, week 10

Study Arms (2)

Complementary and Integrative Medicine online intervention, routine care and book

EXPERIMENTAL

Behavioral: Complementary and Integrative Medicine online intervention, routine care and book

Routine care and book

ACTIVE COMPARATOR

Behavioral: Routine care and book

Interventions

Complementary and Integrative Medicine online intervention, routine care and book BEHAVIORAL

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).

Complementary and Integrative Medicine online intervention, routine care and book

Routine care and book BEHAVIORAL

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.

Routine care and book

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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
• No previous care of post-covid patients

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Berlin, 14109, Germany

RECRUITING

Central Study Contacts

Miriam Rösner

CONTACT

004980505682; naturheilkunde.studien@immanuel.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 22, 2023
• Study Start: September 4, 2023
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

DE (1)