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

Universität Duisburg-Essen

Status: Completed

Conditions: COVID-19; Fatigue

Treatments: Other: waiting group; Behavioral: outpatient clinic with multimodal integrative medicine and naturopathy for post-COVID-19 patients

Study type: Interventional

Funder types: Other

Identifiers

NCT05630378

22011

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Treatment group

Experimental group

Description:

The treatment group has 11 visits in the outpatient clinic of integrative medicine and naturopathy. Additional they fill in a diary and wear a pedometer during the day. Diary and pedometer continue to week 15. In week 12 a video conference with the treatment-group takes place. During week 14+15 a qualitative telephone interview is set. Patients fill in questionnaires before the start of the outpatient clinic and directly afterwards (week 11).

Treatment:

Behavioral: outpatient clinic with multimodal integrative medicine and naturopathy for post-COVID-19 patients

Waiting group

Other group

Description:

Parallel to the treatment group the waiting group receives no intervention, but fills in a diary and wear a pedometer during the day. Their diary and pedometer continue only to week 11. No additional interventions (refresher; video conference; interview) take place. Patients fill in questionnaires before the start of the waiting phase, parallel to the start of the outpatient clinic and directly after its end (week 11).

Treatment:

Other: waiting group