Effects of Kneipp Hydrotherapy in Post-COVID-19 Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Health-related quality of life by Short Form-12 Health Survey (SF-12)
研究概览
简要总结
This randomized controlled study evaluates the effects of cold water hydrotherapy in patients with Post-COVID Syndrome. The primary aim is to assess changes in quality of life compared to an usual care setting without hydrotherapy treatment.
详细描述
Patients recovering from Post-COVID Syndrome often experience persistent fatigue, autonomic dysregulation, microcirculatory disturbances, and low-grade inflammation, all of which may hinder their return to full function. Kneipp hydrotherapy-using cold water applications-can address these pathophysiological changes through several mechanisms:
Autonomic regulation: Cold stimuli trigger parasympathetic activation and improve sympathovagal balance, helping to stabilize heart rate variability and reduce symptoms of dysautonomia often seen in Post-COVID.
Enhanced microcirculation: Repeated vasoconstriction and reactive vasodilation promote endothelial function and tissue perfusion, which may alleviate muscle aches, dizziness, and fatigue by improving oxygen and nutrient delivery.
Anti-inflammatory effects: Hydrothermal stimuli have been shown to modulate cytokine profiles, increasing anti-inflammatory mediators and potentially dampening the persistent, low-grade inflammation implicated in Post-COVID pathophysiology.
Musculoskeletal recovery: Thermo-mechanical stimulation relaxes tense muscle fibers, reduces pain perception, and supports gradual increases in physical capacity, all of which are important for overcoming Post-COVID deconditioning.
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
- None
盲法说明
The statistician that performs the final data analysis is blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Post-COVID Syndrome (ICD-10 code: U08.9)
- •Barthel-Index >80
- •Owning a smartphone to receive digital questionnaires and to use the measurement app for heart rate variability
- •Written informed consent
排除标准
- •Existing contraindications for Kneipp hydrotherapy like severe cardiovascular diseases (e.g., decompensated heart failure, unstable angina pectoris, acute myocardial infarction), severe venous diseases (e.g., acute deep vein thrombosis of the leg), severe neurological diseases (e.g., uncontrolled epilepsy)
- •Prior regular practice of Kneipp applications
结局指标
主要结局
Health-related quality of life by Short Form-12 Health Survey (SF-12)
时间窗: From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)
Change in the Short Form-12 physical and mental component summary scores (minimum score = 0; maximum score = 100; higher scores indicate higher health-related quality of life)
次要结局
- Long-term fatigue by Fatigue Severity Scale(From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4))
- Post-exertional malaise severity(From baseline (Visit 1) to 6-month (Visit 4) follow-up)
- Daily well-being documentation(Daily throughout the intervention and 6 months follow-up phase (Visit 1 to Visit 4))
- Fatigue severity by Fatigue Severity Scale(From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2))
- Sleep quality by Pittsburgh Sleep Quality Index(From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2))
- Health status by EuroQol-5 Dimensions-5 Levels(From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2))
- Autonomic function (heart rate variability by photoplethysmography)(Daily during the 3-week program (Visit 1 to Visit 2))
- Resting blood pressure (systolic and diastolic)(Daily during first 3 weeks of rehabilitation (Visit 1 to Visit 2))
- Post-COVID work-absence days(From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4))
- Long-term quality of life by Short Form-12 Health Survey(From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4))
- Adherence to hydrotherapy(During the 3-week intervention phase (up to Visit 2) and over the 6-month follow-up period (to Visit 4))
- Long-term fatigue by Fatigue Severity Scale(From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4))
- Post-exertional malaise severity(From baseline (Visit 1) to 6-month (Visit 4) follow-up)
- Daily well-being documentation(Daily throughout the intervention and 6 months follow-up phase (Visit 1 to Visit 4))
- Adverse events recording(From start of intervention (Visit 1) through end of study (Visit 4, 6-month follow-up))
- Long-term heart rate variability changes (HRV)(From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4))