Effects of Kneipp Hydrotherapy in Post-COVID-19 Patients

NCT ID: NCT07110714

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-10-31

Brief Summary

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.

Conditions

Post COVID-19 Condition; Post COVID-19 Condition (PCC); Post COVID-19; Post COVID-19 Syndrome; Long COVID-19 Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Post-COVID treatment with 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. During the 3-week stay, standard medical care is provided by registered doctors as needed.

Group Type: EXPERIMENTAL

Cold water hydrotherapy

Intervention Type: OTHER

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.

Usual care setting

Usual care setting at home with no hydrotherapy interventions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bavarian Health and Food Safety Authority (LGL)

UNKNOWN

Sponsor Role: collaborator

Eggensberger OHG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rembert Koczulla, MD

Role: PRINCIPAL_INVESTIGATOR

Schön Klinik Berchtesgadener Land

Locations

Eggensberger Ohg

Füssen, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Andreas Eggensberger, MSc

Role: CONTACT

a.eggensberger@eggensberger.de

+4983629103300

Facility Contacts

Andreas Eggensberger, MSc

Role: primary

a.eggensberger@eggensberger.de

+4983629103300

Other Identifiers

HydroCoVitalB

Identifier Type: -

Identifier Source: org_study_id