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 -
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universität Duisburg-Essen
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Fatigue - Change from week 0 to week 11
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment group
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).
Intervention: outpatient clinic with multimodal integrative medicine and naturopathy for post-COVID-19 patients (Behavioral)
Waiting group
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).
Intervention: waiting group (Other)
Outcomes
Primary Outcomes
Fatigue - Change from week 0 to week 11
Time Frame: before start of intervention (week 0) and afterwards (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).
Secondary Outcomes
- Sleep Quality(before start of intervention (week 0) and afterwards (week 11))
- Hospital Anxiety and Depression(before start of intervention (week 0) and afterwards (week 11))
- Quality of life 2(before start of intervention (week 0) and afterwards (week 11))
- Quality of life 1(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))
- Resilience(before start of intervention (week 0) and afterwards (week 11))
Investigators
Jost Langhorst
Univ.-Prof. Dr. med. (PhD, MD)
Universität Duisburg-Essen