Evaluation of an Integrative Medicine Outpatient Clinical Setting for Post-COVID-19 Patients

COVID-19 Clinical Trial

— TaPoCo  

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 -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05630378
• Other study ID #: 22011
• Status: Completed
• Phase: N/A
• Start date: May 11, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2023
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 30, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Fatigue

Intervention

Behavioral:
• outpatient clinic with multimodal integrative medicine and naturopathy for post-COVID-19 patients
Patients receive multimodal integrative medicine and naturopathy applications with focus on mind-body-medicine and whole body hyperthermia to reduce fatigue and improve quality of life.

Other:
• waiting group
Patients receive no intervention

Locations

Country	Name	City	State
Germany	Sozialstiftung Bamberg, Klinik für Intergrative Medizin	Bamberg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue - Change from week 0 to week 11	measured with MFI-20 questionnaire and Chalder fatigue scale MFI-20: 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Higher total scores correspond with more acute levels of fatigue.; Chalder fatigue scale: a questionnaire to measure the severity of tiredness in fatiguing illnesses. The 11-item chalder fatigue scale is often divided into two components: one that measures physical fatigue (questions 1-7) and one that measures mental fatigue (questions 8-11).	before start of intervention (week 0) and afterwards (week 11)
Secondary	Quality of life 1	SF-12: Short Form of the Health Survey Questionnaire is a 12-item, patient-reported survey of patient health. It is a reduced size version of the SF-36, and is widely used.	before start of intervention (week 0) and afterwards (week 11)
Secondary	Hospital Anxiety and Depression	HADS: Hospital Anxiety and Depression Scale, 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. High scores indicate depressivness and anxiety.	before start of intervention (week 0) and afterwards (week 11)
Secondary	Perceived Stress	PSS-10: Perceived Stress Scale, Rating on a five-step scale from 1 (= never) to 5 (=very often), high stress is assumed from a total score of 20 points	before start of intervention (week 0) and afterwards (week 11)
Secondary	perceived Pain	BPI: Brief Pain Inventory, An inventory including 15 Items about the intensity of pain (4 items, numeric rating scales from 1 (no pain) to 10 (worst pain imaginable), pain impairment (7 items with NRS from 1-10) and the efficacy of medications/treatments. Higher scores indicate higher average pain/pain impairment.	before start of intervention (week 0) and afterwards (week 11)
Secondary	Quality of life 2	EQ-5D: Quality of life EQ-5D is an instrument which evaluates the generic quality of life. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	before start of intervention (week 0) and afterwards (week 11)
Secondary	Sleep Quality	PSQI: Der Pittsburgh Sleep Quality Index It contains seven subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. All items refer to the last four weeks and are assessed either in four frequency levels or in an open-end format. A total sum score from 0 - 21 can be derived from the subscales with higher scores indicating higher sleep disturbance.	before start of intervention (week 0) and afterwards (week 11)
Secondary	Resilience	BRS: Brief Resilience Scale Questionnaire A 6-item questionnaire to assess the perceived ability to bounce back or recover from stress. The possible score range on the BRS is from 1 (low resilience) to 5 (high resilience).	before start of intervention (week 0) and afterwards (week 11)