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Идёт набор NCT07110714

Effects of Kneipp Hydrotherapy in Post-COVID-19 Patients

Без фазы С лечением Post COVID-19 Condition Post COVID-19 Condition (PCC) Post COVID-19 Post COVID-19 Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cold water hydrotherapy.
Кому может быть актуально
Состояния в реестре: Post COVID-19 Condition, Post COVID-19 Condition (PCC), Post COVID-19, Post COVID-19 Syndrome. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of Kneipp Hydrotherapy in Post-COVID-19 Patients: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Taken together, these effects suggest that adjunctive cold water hydrotherapy could accelerate functional recovery, reduce symptom burden, and enhance quality of life in Post-COVID rehabilitation.

Baseline Assessments:

At baseline, demographic data including sex, age, height, and weight will be collected. Participants will report their current main Post-COVID symptoms, which will be categorized into symptom clusters: Fatigue (A), Cognitive (B), and Somatic (C). Smoking history will be assessed, including smoking status (current, former, or never), number of cigarettes per day, years of smoking, and pack-years.

The time (in months) since the COVID-19 infection that led to Post-COVID syndrome will be documented, along with the number of COVID-19 vaccinations received at the time of infection. Employment status will be recorded, distinguishing between full-time or part-time employment, COVID-related work disability, retirement, unemployment, or disability pension.

Comorbidities will be documented across the following categories: cardiovascular, pulmonary, cerebrovascular, metabolic, musculoskeletal, psychiatric, and other conditions. The severity of the acute COVID-19 illness will be assessed using the WHO Clinical Progression Scale, including information on any hospital admission and length of stay (in days).

Autonomic function testing at baseline (V1) will be evaluated using the Schellong test. Additionally, self-reported work ability and the number of Post-COVID-related sick leave days within the past 12 weeks will be recorded.

Вмешательства

  • Другое Cold water hydrotherapy
    Cold water hydrotherapy (5-10 minutes each), four times daily during the 3-week program and once daily during the 6-month follow-up period. Hydrotherapy interventions are individually tailored to each subject based on their responses and include various washing and pouring techniques.

Первичные конечные точки

  • Health-related quality of life by Short Form-12 Health Survey (SF-12) [Срок оценки: From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)]
Вторичные конечные точки (12)
  • Fatigue severity by Fatigue Severity Scale [Срок оценки: From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)]
  • Sleep quality by Pittsburgh Sleep Quality Index [Срок оценки: From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)]
  • Health status by EuroQol-5 Dimensions-5 Levels [Срок оценки: From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)]
  • Autonomic function (heart rate variability by photoplethysmography) [Срок оценки: Daily during the 3-week program (Visit 1 to Visit 2)]
  • Resting blood pressure (systolic and diastolic) [Срок оценки: Daily during first 3 weeks of rehabilitation (Visit 1 to Visit 2)]
  • Post-COVID work-absence days [Срок оценки: 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 [Срок оценки: From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4)]
  • Long-term fatigue by Fatigue Severity Scale [Срок оценки: From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4)]
  • Adherence to hydrotherapy [Срок оценки: During the 3-week intervention phase (up to Visit 2) and over the 6-month follow-up period (to Visit 4)]
  • Adverse events recording [Срок оценки: From start of intervention (Visit 1) through end of study (Visit 4, 6-month follow-up)]
  • Long-term heart rate variability changes (HRV) [Срок оценки: From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4)]
  • Post-exertional malaise severity [Срок оценки: From baseline (Visit 1) to 6-month (Visit 4) follow-up]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Германия · 1 центр
  • Eggensberger Ohg — Füssen

Идентификаторы

NCT: NCT07110714 · HydroCoVitalB

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗