Evaluation of the Efficacy of Mild Water-filtered Infrared-A Whole-body Hyperthermia to Improve Symptoms and Quality of Life in Patients With Post-COVID Syndrome (HyPoCo)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Multidimensionl Fatigue Inventory (MFI-20)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
mild hyperthermia group
For the study, the method of passive whole-body hyperthermia is used. The IRATHERM®1000 system (Von Ardenne Institute for Applied Medical Research/Dresden) is used, in which the entire body is heated to a core body temperature above the physiological 37°C under the application of 10L/min oxygen. The aim is to achieve a core body temperature of 38.5°C within the framework of mild whole-body hyperthermia. After this warm-up phase, a temperature plateau phase of about 60 minutes follows, in which an attempt is made to maintain the core body temperature of 38.5°C. In the temperature plateau phase, a slight increase in the body core temperature is usually observed. The total time required for a session is given as 1.5 to 2 hours, but this depends on the individual constitution and daily condition of the patient and can be subject to fluctuations.
干预措施: mild hyperthermia group (Other)
sham group
Within the patient information, privacy policy, etc., there is talk of "gentle hyperthermia" and classic, "mild hyperthermia". This serves to introduce the sham intervention as a control group compared to the patient. Lighting conditions, procedures, instructions and explanations are indistinguishable. Within the application, patients of the sham group will receive a hyperthermia application almost without overheating. In order to achieve this, the patients will be positioned on the IRATHERM®1000 in accordance with the Von Ardenne Institute's regulations. Due to the insulating blanket and the natural device and body heat, the patients of the sham group experience a gentle warmth, which is not the same as regular whole-body hyperthermia and an increase in the body core temperature of about 1.5 °C. In the sham setting, the core body temperature increases by about 0.3 to 0.4 °C within a 55-minute session.
干预措施: sham group (Other)
结局指标
主要结局
Multidimensionl Fatigue Inventory (MFI-20)
时间窗: Week 3
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).
Multidimensionl Fatigue Inventory (MFI-20)
时间窗: 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).
次要结局
- Multidimensionl Fatigue Inventory (MFI-20)(Week 15)
- Pittsburgh Sleep quality index (PSQI)(Week 15)
- Adverse events (AE)(Week 1-2)
- Generic quality of life(Week 15)
- Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)(Week 15)
- Anxiety and Depression(Week 15)
- Quality of life (EQ-5D)(Week 15)
- G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)(Week 15)
- Canadian consensus criteria (CCC)(Week 0)
- Pedometer (step count)(Week 1-15)
- Perceived Stress (PSS-10)(Week 15)
- Patient Interview(Week 8-10)
- Patient Diary(Week 1-15)
- Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)(Week 0)
- Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)(Week 3)
- Pittsburgh Sleep quality index (PSQI)(Week 0)
- Pittsburgh Sleep quality index (PSQI)(Week 3)
- Generic quality of life(Week 0)
- Generic quality of life(Week 3)
- Quality of life (EQ-5D)(Week 0)
- Quality of life (EQ-5D)(Week 3)
- Anxiety and Depression(Week 0)
- Anxiety and Depression(Week 3)
- G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)(Week 0)
- G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)(Week 3)
- Perceived Stress (PSS-10)(Week 0)
- Perceived Stress (PSS-10)(Week 3)
研究者
Jost Langhorst
Prof. Dr. med.
Universität Duisburg-Essen