Effects of Kneipp Hydrotherapy in Post-COVID-19 Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cold water hydrotherapy.
- Who it may be relevant to
- Registry conditions: Post COVID-19 Condition, Post COVID-19 Condition (PCC), Post COVID-19, Post COVID-19 Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Kneipp Hydrotherapy in Post-COVID-19 Patients: A Randomized Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- Other 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.
Primary outcome measures
- Health-related quality of life by Short Form-12 Health Survey (SF-12) [Time frame: From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)]
Secondary outcome measures (12)
- Fatigue severity by Fatigue Severity Scale [Time frame: From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)]
- Sleep quality by Pittsburgh Sleep Quality Index [Time frame: From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)]
- Health status by EuroQol-5 Dimensions-5 Levels [Time frame: From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)]
- Autonomic function (heart rate variability by photoplethysmography) [Time frame: Daily during the 3-week program (Visit 1 to Visit 2)]
- Resting blood pressure (systolic and diastolic) [Time frame: Daily during first 3 weeks of rehabilitation (Visit 1 to Visit 2)]
- Post-COVID work-absence days [Time frame: 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 [Time frame: From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4)]
- Long-term fatigue by Fatigue Severity Scale [Time frame: From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4)]
- Adherence to hydrotherapy [Time frame: During the 3-week intervention phase (up to Visit 2) and over the 6-month follow-up period (to Visit 4)]
- Adverse events recording [Time frame: From start of intervention (Visit 1) through end of study (Visit 4, 6-month follow-up)]
- Long-term heart rate variability changes (HRV) [Time frame: From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4)]
- Post-exertional malaise severity [Time frame: From baseline (Visit 1) to 6-month (Visit 4) follow-up]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Eggensberger Ohg — Füssen
Identifiers
NCT: NCT07110714 · HydroCoVitalB