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| Name | Class |
|---|---|
| Bavarian Health and Food Safety Authority (LGL) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual care setting | No Intervention | Usual care setting at home with no hydrotherapy interventions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue severity by Fatigue Severity Scale | Change in Fatigue Severity Scale score (minimum score = 9; maximum score = 63; higher scores indicate greater fatigue severity) | From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2) |
| Sleep quality by Pittsburgh Sleep Quality Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Eggensberger, MSc | Contact | +4983629103300 | a.eggensberger@eggensberger.de |
| Name | Affiliation | Role |
|---|---|---|
| Rembert Koczulla, MD | Schön Klinik Berchtesgadener Land | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eggensberger Ohg | Recruiting | Füssen | Bavaria | D-87629 | Germany |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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The statistician that performs the final data analysis is blinded to group allocation.
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|
Change in Pittsburgh Sleep Quality Index score (minimum score = 0; maximum score = 21; higher scores indicate poorer sleep quality) |
| From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2) |
| Health status by EuroQol-5 Dimensions-5 Levels | Change in EuroQol-5 Dimensions-5 Levels questionnaire score (score represented by a 5-digit code; each digit represents one dimension, ranging from 1 to 5; higher digits indicate poorer health state) | From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2) |
| Autonomic function (heart rate variability by photoplethysmography) | Change in heart rate variability (root mean square of successive differences) measured by Kyto 2935 via photoplethysmography | Daily during the 3-week program (Visit 1 to Visit 2) |
| Resting blood pressure (systolic and diastolic) | Change in morning resting systolic and diastolic blood pressure | Daily during first 3 weeks of rehabilitation (Visit 1 to Visit 2) |
| Post-COVID work-absence days | Number of days of work absence due to Post-COVID-19 symptoms during the past 12-weeks | 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 | Change in Short Form-12 scores at follow-up (minimum score = 0; maximum score = 100; higher scores indicate higher health-related quality of life) | From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4) |
| Long-term fatigue by Fatigue Severity Scale | Change in Fatigue Severity Scale score at follow-up (minimum score = 9; maximum score = 63; higher scores indicate greater fatigue severity) | From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4) |
| Adherence to hydrotherapy | Proportion of prescribed hydrotherapy applications in the intervention group performed, as recorded in diary or app. Short-term Adherence: During the 3-week intervention phase, patients are considered "adherent" if they perform atleast one hydrotherapy session per day on at least 75% of study days. The investigators will compare health improvements between high-adherence and low-adherence participants. Long-term Adherence and Effects: Over the 3- and 6-month follow-up, "adherent" patients are those who continue self administered hydrotherapy at least four times per week on at least 75% of follow-up weeks. The investigators will assess whether these patients sustain greater gains in quality of life. | During the 3-week intervention phase (up to Visit 2) and over the 6-month follow-up period (to Visit 4) |
| Adverse events recording | Number and severity of adverse events related to Kneipp hydrotherapy | From start of intervention (Visit 1) through end of study (Visit 4, 6-month follow-up) |
| Long-term heart rate variability changes (HRV) | Change in heart rate variability parameters (root mean square of successive differences) measured by photoplethysmography. At follow-up visits patients will measure HRV for 7 consecutive days | From baseline (Visit 1) to 3 months (Visit 3) and to 6 months (Visit 4) |
| Post-exertional malaise severity | Change in Post-Exertional Malaise score measured by the DePaul Symptom Questionnaire-Post-Exertional Malaise | From baseline (Visit 1) to 6-month (Visit 4) follow-up |
| Daily well-being documentation | Self-reported daily well-being recorded via digital diary on a scale from 0 to 100 | Daily throughout the intervention and 6 months follow-up phase (Visit 1 to Visit 4) |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |