Effects of Hydrotherapy During Post-COVID-19 Rehabilitation

NCT ID: NCT07013903

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-21
• Study Completion Date: 2027-10-31

Brief Summary

This randomized controlled study evaluates the effects of cold water hydrotherapy as an adjunct to standard rehabilitation in patients with Post-COVID Syndrome. The primary aim is to assess changes in quality of life compared to standard rehabilitation alone.

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).

Pulmonary function testing at baseline (V1) will include FEV₁, FVC, FEV₁/FVC ratio, and total lung capacity (TLC), all expressed as percent predicted. Autonomic function will be evaluated using the Schellong test. Vascular status will be assessed by four-limb blood pressure measurement. 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 / Long-COVID; POST-Covid 19; Post COVID Syndrome; Post-COVID Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Post-COVID Rehabilitation with hydrotherapy

Cold water hydrotherapy (5-10 minutes each), twice daily during the 3-week multimodal inpatient rehabilitation program and once daily during the 6-month follow-up period

Group Type: EXPERIMENTAL

Standard rehabilitation plus cold water hydrotherapy

Intervention Type: OTHER

Cold water hydrotherapy (5-10 minutes each), twice daily during the 3-week multimodal inpatient rehabilitation program and once daily during the 6-month follow-up period

Post-COVID Rehabilitation without hydrotherapy

3-week inpatient multimodal inpatient rehabilitation program without hydrotherapy

Group Type: ACTIVE_COMPARATOR

Standard rehabilitation only

Intervention Type: OTHER

same rehabilitation program than the experimental group but without hydrotherapy

Interventions

Standard rehabilitation plus cold water hydrotherapy

Cold water hydrotherapy (5-10 minutes each), twice daily during the 3-week multimodal inpatient rehabilitation program and once daily during the 6-month follow-up period

Intervention Type: OTHER

Standard rehabilitation only

same rehabilitation program than the experimental group but without hydrotherapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of Post-COVID Syndrome (ICD-10 code: U08.9)
• Barthel-Index >80
• Referred to the reference center for Post-COVID rehabilitation
• 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

Schön Klinik Berchtesgadener Land

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Andreas Rembert Koczulla

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rembert Koczulla, MD

Role: PRINCIPAL_INVESTIGATOR

Schön Klinik Berchtesgadener Land

Locations

Schön Klinik Berchtesgadener Land

Schönau am Königssee, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Rainer Gloeckl, PhD

Role: CONTACT

rgloeckl@schoen-klinik.de

+498652931630

Facility Contacts

Rainer Gloeckl, PhD

Role: primary

rgloeckl@schoen-klinik.de

+498652931630

Other Identifiers

HydroCoVital A

Identifier Type: -

Identifier Source: org_study_id