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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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).
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.
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Berlin, Germany
RECRUITINGShort 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.
Time frame: Baseline, 10 weeks
Short Form 36 (SF-36)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
DePaul Post-Exertional Malaise Questionnaire (DSQ-PEM)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Post-COVID-Syndrom (PCS) Score
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Chalder Fatigue Scale (CFS)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Quality of life (EQ-5D-5L)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
General Self-Efficacy Scale (GSE, German version: ASKU)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
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Visual analog scale (VAS) physical strength
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Visual analog scale (VAS) mental strength
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Visual analog scale (VAS) headache
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Patient Health Questionnaire 9 (PHQ9)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Pittsburgh Sleep Quality Index (PSQI)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Lifestyle questions (diet, alcohol, cigarettes, relaxation, hydrotherapie, nature stays, physical activity)
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Expectation regarding study intervention
5-point likert-scale. The scale ranges from 0 to 5, where 0 is the lowest level and 5 is the highest level.
Time frame: Baseline
Perceived Stress Scale (PSS 4)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Satisfaction with the intervention
5-point likert-scale. The scale ranges from 0 to 5, where 0 is the lowest level and 5 is the highest level.
Time frame: Week 10
Safety by recording adverse events
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Adherence to the study intervention
Asking Minutes (min.) of the last week
Time frame: Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
Online diaries for assessing routine care (GP prescriptions/measures, especially medication and phytotherapy/nutritional supplements)
Time frame: Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 20, week 30, week 40, week 50
Continuation of the intervention
Asking Minutes (min.) of the last month
Time frame: 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks