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Effects of Kneipp Hydrotherapy in Post-COVID-19 Patients

ConditionsPost COVID-19 ConditionPost COVID-19 Condition (PCC)Post COVID-19Post COVID-19 SyndromeLong COVID-19 Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEggensberger OHG

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cold water hydrotherapy

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Post-COVID treatment with hydrotherapyExperimental treatment 1 intervention
Group B: Usual care settingNo intervention 0 interventions

Trial outcomes

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)

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

Secondary outcomes

1

Fatigue severity by Fatigue Severity Scale

Change in Fatigue Severity Scale score (minimum score = 9; maximum score = 63; higher scores indicate greater fatigue severity)

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

Sleep quality by Pittsburgh Sleep Quality Index

Change in Pittsburgh Sleep Quality Index score (minimum score = 0; maximum score = 21; higher scores indicate poorer sleep quality)

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

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)

Time frame
From baseline (Visit 1) to end of 3-week program (3 weeks, Visit 2)
4

Autonomic function (heart rate variability by photoplethysmography)

Change in heart rate variability (root mean square of successive differences) measured by Kyto 2935 via photoplethysmography

Time frame
Daily during the 3-week program (Visit 1 to Visit 2)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eggensberger OHG

Lead sponsor

Bavarian Health and Food Safety Authority (LGL)

Collaborator

Source ClinicalTrials.gov
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