Post-COVID Syndrome
Conditions
Keywords
hyperthermia, fatigue, post-COVID syndrome
Brief summary
This study examines the efficacy of mild water-filtered whole-body hyperthermia during outpatient treatment in patients with post-COVID syndrome. The aim is to evaluate whether there can be an improvement in fatigue and quality of life. The duration of the study extends over a treatment period of approximately 2 weeks with two treatment units per week and a follow-up period of 3 months after the outpatient treatment.
Detailed description
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.
Interventions
OTHERmild 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.
OTHERsham 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.
Sponsors
Bavarian State Ministry of Health and Care
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multidimensionl Fatigue Inventory (MFI-20) | Week 0 | An inventory including 20 questions about fatigue-symptoms (each from 1 (Yes, that is true) to 5 (No, that is not true)) covering 5 dimensions (general fatigue, physical fatigue, reduced motivation, reduced activity, mental fatigue). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generic quality of life | Week 0 | Short Form SF-12 Health Survey Questionnaire; A low total value correlates with a poor quality of life, a higher one with a better one. |
| G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects) | Week 0 | A non validated inventory including 11 items measuring pre-experiences, treatment expectations and treatment effects. |
| Perceived Stress (PSS-10) | Week 0 | Perceived stress is determined using the Perceived Stress Scale (PSS). The PSS is an international standard instrument for recording subjective stress levels. The official German 10-item version is used in the study. |
| Canadian consensus criteria (CCC) | Week 0 | This is a questionnaire for the diagnosis of CFS/ME (Carruthers et al. 2003). This definition scheme can be used to clinically confirm the diagnosis of CFS/ME. The list of criteria includes the following symptom complexes: Fatigue, exercise intolerance (PEM), sleep disturbances, pain, neurological or cognitive symptoms, autonomic symptoms, neuroendocrine symptoms and immunological symptoms. |
| Patient Interview | Week 8-10 | Qualitative telephone interviews with 16-20 patients of the mild whole-body hyperthermia group (Experimental group) to get detailed experiences of the patients (30-45 min). |
| Adverse events (AE) | Week 1-2 | Description of adverse events during the interventions by therapists. |
| Patient Diary | Week 1-15 | Documentation of pain progression, energy level, sleep, medication intake, number of steps, adverse events |
| Pedometer (step count) | Week 1-15 | Individual activity profile |
| Multidimensionl Fatigue Inventory (MFI-20) | Week 15 | An inventory including 20 questions about fatigue-symptoms (each from 1 (Yes, that is true) to 5 (No, that is not true)) covering 5 dimensions (general fatigue, physical fatigue, reduced motivation, reduced activity, mental fatigue). |
| Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS) | Week 0 | An inventory including 15 Items about the intensity of pain (4 items, numeric rating scales from 1 (no pain) to 10 (worst pain imaginable); primary outcome), pain impairment (7 items with NRS from 1-10) and the efficacy of medications/treatments. |
| Pittsburgh Sleep quality index (PSQI) | Week 0 | An inventory including 10 questions (plus subquestions) about the quality of sleep. Most of the questions range from (Not during the past month to thee or more times a week). The questions can be calculated in seven subscales. |
| Quality of life (EQ-5D) | Week 0 | The EQ-5D measures 5 dimensions of quality of life (mobility, self-care, general activities, pain/physical discomfort and anxiety/depression) as well as the general state of health on a VAS from 0-100. |
| Anxiety and Depression | Week 0 | Hospital Anxiety and Depression Scale (HADS), 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood cell sedimenation rate (BSG) | Week 0 | to measure inflammation |
| Cytokine panel | Week 0 - baseline status | Plasma levels of cytokines (TNF-a, IL-6, IL-8, IL-10, etc.) |
| post-Covid autoantibodies | Week 0 - baseline status | blood parameter |
| Post-Covid pathogen reactivation | Week 0 - baseline status | pathogens EBV, CMV, VZV, Pan-/Corona; analysis by Elispot method |
| Real time deformability cytometry (RT-DC) | Week 0 - baseline status | Blood cell characterization |
| C-reactive Protein (CRP) | Week 0 | Level of C-reactive protein (CRP) in blood to measure inflammation |
| Blood count | Week 0 | (to measure baseline status) |
Countries
Germany
Outcome results
None listed