Effects of Kneipp Hydrotherapy in Post-COVID-19 Patients

NCT07110714 | Recruiting

• 1 other identifier: HydroCoVitalB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

therapy; intervention; hydrotherapy; Kneipp; balneotherapy; quality of life; PCC; long COVID; post COVID-19

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life by Short Form-12 Health Survey (SF-12)

  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)

  From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)

Secondary Outcomes (13)

• 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)

Study Arms (2)

Post-COVID treatment with hydrotherapy

EXPERIMENTAL

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.

Other: Cold water hydrotherapy

Usual care setting

NO INTERVENTION

Usual care setting at home with no hydrotherapy interventions.

Interventions

Cold water hydrotherapy 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.

Post-COVID treatment with hydrotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eggensberger OHG: lead
• Bavarian Health and Food Safety Authority (LGL): collaborator

Study Sites (1)

Eggensberger Ohg

Füssen, Bavaria, D-87629, Germany

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rembert Koczulla, MD

  Schön Klinik Berchtesgadener Land

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Eggensberger, MSc

CONTACT

+4983629103300; a.eggensberger@eggensberger.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The statistician that performs the final data analysis is blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)