Clinical trial NCT05630378: Evaluation of an Integrative Medicine Outpatient Clinical Setting for Post-COVID-19 Patients
Official title: Evaluation of a Multimodal Integrative Medicine and Naturopathy Program in an Outpatient Setting With Focus on Mind-Body Medicine and Mild Water-filtered Infrared-A Whole-body Hyperthermia for Improvement of Symptoms and Quality of Life in Patients With Post-COVID-19-syndrome - a Prospective Randomised Controlled Study -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Fatigue
Keywords: Covid-19
fatigue
outpatient clinic
integrative naturopathy
integrative medicine
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel to the treatment group that visits the outpatient clinic on one day of the week for 11 weeks, the waiting group only fills in a diary and the questionnaires at two timepoints. Diary and questionnaires are the same for both groups.
Primary purpose: TREATMENT

Brief summary: The study aims to identify whether a multimodal integrative naturopathy outpatient clinical concept can improve the symptoms of patients suffering from post-COVID-Syndrome. Main outcome is fatigue. The outpatient clinical programme consists of 11 weeks wherein patients visit the clinic one day per week. The pillars of classical naturopathy are combined with extended naturopathy and complementary procedures. Previous naturopathical studies on patients with chronic fatigue syndrome could find numerous indications that different types of naturopathy can help patients with fatigue.


Eligibility criteria: Inclusion Criteria:

* 18 to 75 years of age
* diagnosed with post covid syndrome
* fatigue with or without myalgia
* signed declaration of consent

Exclusion Criteria:

* contraindications for whole body infrared hyperthermia (severe cardiovascular diseases, tumour diseases, acute infections, pregnant and breastfeeding women)
* Acute and or feverish microbially infections
* Pleuritic chest pain
* Relevant shortness of breath
* Zn Critical illness or intensive medical care because of COVID 19
* Patients with severe somatic, cardiovascular pneumological, rheumatic, endocrine or neurological comorbidities. Especially neurological disorders accompanied by cognitive impairment, severe liver or kidney disorders.
* Patients permanently treated with opioids, cannabis, immunosuppressive agents (e.g. corticoids, immunsuppressives) or alpha/beta-a(nta)gonists
* Patients with pain as a consequence of a severe psychiatric disease (bipolar disorder, psychosis, personality disorder, severe depression, substance abuse) as well as severe systematic disorders or neurological disorders
* Participation in other clinical studies

Primary outcomes:
measure: Fatigue - Change from week 0 to week 11
timeFrame: before start of intervention (week 0) and afterwards (week 11)
Secondary outcomes:
measure: Quality of life 1
timeFrame: before start of intervention (week 0) and afterwards (week 11)
measure: Hospital Anxiety and Depression
timeFrame: before start of intervention (week 0) and afterwards (week 11)
measure: Perceived Stress
timeFrame: before start of intervention (week 0) and afterwards (week 11)
measure: perceived Pain
timeFrame: before start of intervention (week 0) and afterwards (week 11)
measure: Quality of life 2
timeFrame: before start of intervention (week 0) and afterwards (week 11)
measure: Sleep Quality
timeFrame: before start of intervention (week 0) and afterwards (week 11)
measure: Resilience
timeFrame: before start of intervention (week 0) and afterwards (week 11)
Other outcomes:
Locations:
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg, Klinik für Intergrative Medizin
state: Bayern
Study officials:
affiliation: Sozialstiftung Bamberg
name: Jost Langhorst, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: