This study examines the efficacy of mild water-filtered whole-body hyperthermia duringoutpatient treatment in patients with post-COVID syndrome. The aim is to evaluate whetherthere can be an improvement in fatigue and quality of life. The duration of the studyextends over a treatment period of approximately 2 weeks with two treatment units perweek and a follow-up period of 3 months after the outpatient treatment.
A total of about 60 participants over 18 years of age are sought, who will be divided
into two groups of equal size after inclusion in the study. All participants will receive
the same amount of water-filtered whole-body hyperthermia (WBH) under application of 10
L/min oxygen within the outpatient setting. One group receives the gentle form of WBH,
the other group receives the classic, mild WBH, which differ in the intensity of the
radiation. Gentle hyperthermia serves as a control group for mild hyperthermia.
All abnormalities are documented by the responsible therapists, doctors and nurses.
Blood parameters are collected before the start, after 2 applications and after the last
application during the clinical stay. The aim here is to determine the differential blood
count and inflammatory and immune parameters; among other things, autoantibody production
is to be examined and monitored during the course of the study. In order to check the
possible effectiveness of the treatment, various questionnaire values are also collected.
The survey will take place at 3 points in time (at the beginning, after completion of the
4 treatments and 3 months afterwards).
In addition, a diary will be filled out in which patients will provide information on
their sleep, personal energy level and pain level as well as their daily step count in
order to create an activity profile. All patients receive a paper diary and a pedometer
adapted to their individual characteristics in advance. The diary is to be kept from week
0 to week 15.
After completion of the study, qualitative interviews lasting around 30-45 minutes will
be conducted with 16-20 participants in weeks 8-10 of the follow-up period. Participants
are selected on the basis of socio-demographic and clinical characteristics with the aim
of obtaining a sample that is as heterogeneous as possible. The interviews are conducted
by telephone.
Other: mild hyperthermia group
The hyperthermia treatment is carried out in a cycle of two treatments per week, with at
least one day in between, over a period of two weeks, according to the manufacturer's
instructions. For better tolerability, the application takes place under administration
of 10L/min oxygen. According to the guidelines, the rectal (possibly vaginal) temperature
(as body core temperature), heart rate and oxygen saturation (Sp02) are continuously
determined during the hyperthermia treatment. During the treatment, continuous
supervision by trained personnel is guaranteed, and a doctor is on call.
Other: sham group
Within the application, patients in the Sham group will undergo a hyperthermia
application with virtually no overheating. To achieve this, the patients are positioned
on the hyperthermia device in the same way as the intervention group. An insulating foil
applied beforehand prevents direct irradiation with water-filtered infrared-A radiation.
This prevents an increase in temperature. Due to the insulating blanket and the natural
heat from the device and body, patients in the Sham group experience a gentle warmth that
cannot be compared with regular whole-body hyperthermia and an increase in core body
temperature of around 1.5°C. The number of treatments, the lighting conditions and
procedures including 10L/min oxygen supply, is equal to the treatments in the
intervention group.
Inclusion Criteria:
- Patients aged between 18 and 75 years
- Confirmed diagnosis of post-COVID syndrome
- Fatigue: at least 51.5 points on the MFI-20 scale.
- Signed declaration of consent
Exclusion Criteria:
- Participation in other clinical studies
- Contraindications for hyperthermia (severe cardiovascular diseases with/above NYHA
II, active tumor diseases, acute infections, hyperthyroidism (not adjusted),
pregnant and breastfeeding women, epilepsy, high-grade cardiac arrhythmia including
atrial fibrillation, multiple sclerosis, major skin lesions, photosensitivity
disease, acute exacerbated bronchial asthma/COPD [Gold II to IV])
- Pleuritic chest pain
- Hyperthyroidism
- Poorly controlled diabetes mellitus
- Condition after critical illness due to COVID-19
- Patients with active tumor disease, with pneumological, rheumatic, endocrine or
neurological concomitant diseases (including dementia, epilepsy, multiple
sclerosis), in particular neurological diseases associated with cognitive or sensory
disorders
- Severe liver or kidney diseases (liver cirrhosis, post liver transplant, autoimmune
hepatitis, dialysis patients, post kidney transplant, acute kidney failure,
autoimmune nephropathy)
- Patients with chronic cannabis use (exception: CBD for myalgia), long-term use of
WHO class III opioids (e.g. for myalgia/joint pain), long-term use of
immunosuppressive medication (steroids, biologics, MTX, leflunomide, azathioprine)
- Patients with psychiatric disorders (bipolar disorder, psychosis, schizophrenia,
personality disorder)
Sozialstiftung Bamberg
Bamberg, Germany
Jost Langhorst, Prof. Dr., Principal Investigator
Sozialstiftung Bamberg