Health TrialsbyHealthPanel

Effects of Hydrotherapy During Post-COVID-19 Rehabilitation

ConditionsPost-COVID / Long-COVIDPOST-Covid 19Post COVID SyndromePost-COVID Condition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSchön Klinik Berchtesgadener Land

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

  • Standard rehabilitation plus cold water hydrotherapy

    Other intervention

    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

  • Standard rehabilitation only

    Other intervention

    same rehabilitation program than the experimental group but without hydrotherapy

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Post-COVID Rehabilitation with hydrotherapyExperimental treatment 1 intervention
Group B: Post-COVID Rehabilitation without hydrotherapyActive comparator 1 intervention

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

Time frame
From baseline (Visit 1) to end of inpatient rehabilitation (3 weeks, Visit 2)

Secondary outcomes

1

Fatigue severity by Fatigue Severity Scale

Change in Fatigue Severity Scale score

Time frame
From baseline (Visit 1) to end of inpatient rehabilitation (3 weeks, Visit 2)
2

Sleep quality by Pittsburgh Sleep Quality Index

Change in Pittsburgh Sleep Quality Index score

Time frame
From baseline (Visit 1) to end of inpatient rehabilitation (3 weeks, Visit 2)
3

Health status by EuroQol-5 Dimensions-5 Levels

Change in EuroQol-5 Dimensions-5 Levels questionnaire score

Time frame
From baseline (Visit 1) to end of inpatient rehabilitation (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 first 3 weeks of rehabilitation (Visit 1 to Visit 2)

Other outcomes

Sponsors and contacts

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

Schön Klinik Berchtesgadener Land

Lead sponsor

Bavarian Health and Food Safety Authority (LGL)

Collaborator

Source ClinicalTrials.gov
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