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

NCT05630378 | Completed

• 1 other identifier: 22011
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Fatigue

Keywords

Covid-19; fatigue; outpatient clinic; integrative naturopathy; integrative medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Quality of life 1

  before start of intervention (week 0) and afterwards (week 11)

• Hospital Anxiety and Depression

  before start of intervention (week 0) and afterwards (week 11)

• Perceived Stress

  before start of intervention (week 0) and afterwards (week 11)

• perceived Pain

  before start of intervention (week 0) and afterwards (week 11)

• Quality of life 2

  before start of intervention (week 0) and afterwards (week 11)

Study Arms (2)

Treatment group

EXPERIMENTAL

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).

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

Waiting group

OTHER

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).

Other: waiting group

Interventions

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

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.

Treatment group

waiting group OTHER

Patients receive no intervention

Waiting group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (1)

Sozialstiftung Bamberg, Klinik für Intergrative Medizin

Bamberg, Bavaria, 96049, Germany

Location

Related Publications (1)

• Uecker C, Schlee C, Utz S, Schmid S, Langhorst J. Integrative multimodal treatment approach for patients suffering from Post-COVID syndrome: a study based on qualitative interviews with individuals participating in an 11-week day clinic program. Front Public Health. 2025 Dec 3;13:1688592. doi: 10.3389/fpubh.2025.1688592. eCollection 2025.

  PMID: 41415232 DERIVED

MeSH Terms

Conditions

COVID-19; Fatigue

Interventions

Ambulatory Care Facilities; Naturopathy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services; Complementary Therapies; Therapeutics

Study Officials

• Jost Langhorst, Prof. Dr.

  Sozialstiftung Bamberg

  PRINCIPAL INVESTIGATOR

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: Univ.-Prof. Dr. med. (PhD, MD)

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: November 29, 2022
• Study Start: May 11, 2022
• Primary Completion: February 1, 2023
• Study Completion: June 30, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

DE (1)