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COVID-19TaPoCoNCT05630378

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

A study testing outpatient clinic with multimodal integrative medicine and naturopathy for post-COVID-19 patients and waiting group in people with COVID-19 and Fatigue, run by Universität Duisburg-Essen at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
COVID-19, Fatigue
What is being tested?
outpatient clinic with multimodal integrative medicine and naturopathy for post-COVID-19 patients and waiting group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteGermany
Study dates
11 May 2022to 30 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
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  • 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 locations and contacts

1 site in 1 country.

Germany1 site

  • Sozialstiftung Bamberg, Klinik für Intergrative Medizin

    Bamberg, Bavaria, 96049

Other trials in Germany

About this study

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 -

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
Being tested
outpatient clinic with multimodal integrative medicine and naturopathy for post-COVID-19 patients, waiting group
Keywords
Covid-19, fatigue, outpatient clinic, integrative naturopathy, integrative medicine
Medical subject headings
COVID-19, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • outpatient clinic with multimodal integrative medicine and naturopathy for post-COVID-19 patientsBehavioural

    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.

  • waiting groupOther

    Patients receive no intervention

Study groups in NCT05630378
Study groupRoleWhat they receive
Treatment groupExperimentalThe 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).
Receives: Behavioral: outpatient clinic with multimodal integrative medicine and naturopathy for post-COVID-19 patients
Waiting groupOtherParallel 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).
Receives: Other: waiting group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (7)

  1. 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.

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

  2. 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.

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

  3. 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

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2022
  2. Study start11 May 2022
  3. Primary completion1 Feb 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05630378
Sponsor's protocol ID
22011
Acronym
TaPoCo
Status last verified
Nov 2023
First submitted
26 Aug 2022
Last updated
4 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41415232

Questions about this trial

What is this clinical trial studying?

A study testing outpatient clinic with multimodal integrative medicine and naturopathy for post-COVID-19 patients and waiting group in people with COVID-19 and Fatigue, run by Universität Duisburg-Essen at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue - Change from week 0 to week 11 (time frame: before start of intervention (week 0) and afterwards (week 11)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05630378, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.

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