NCT07013903

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Aug 2025Oct 2027

First Submitted

Initial submission to the registry

June 5, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 21, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

June 5, 2025

Last Update Submit

August 21, 2025

Conditions

Post-COVID / Long-COVIDPOST-Covid 19Post COVID SyndromePost-COVID Condition

Keywords

rehabilitationtherapyPost-COVIDLong COVIDinterventionhydrotherapyKneippbalneotherapyPost-COVID conditionquality of life

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

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

Secondary Outcomes (13)

  • Fatigue severity by Fatigue Severity Scale

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

  • Sleep quality by Pittsburgh Sleep Quality Index

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

  • Health status by EuroQol-5 Dimensions-5 Levels

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

  • Autonomic function (heart rate variability by photoplethysmography)

    Daily during first 3 weeks of rehabilitation (Visit 1 to Visit 2)

  • Resting blood pressure (systolic and diastolic)

    Daily during first 3 weeks of rehabilitation (Visit 1 to Visit 2)

  • +8 more secondary outcomes

Study Arms (2)

Post-COVID Rehabilitation with hydrotherapy

EXPERIMENTAL

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

Other: Standard rehabilitation plus cold water hydrotherapy

Post-COVID Rehabilitation without hydrotherapy

ACTIVE COMPARATOR

3-week inpatient multimodal inpatient rehabilitation program without hydrotherapy

Other: Standard rehabilitation only

Interventions

Standard rehabilitation plus cold water hydrotherapyOTHER

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 with hydrotherapy
Standard rehabilitation onlyOTHER

same rehabilitation program than the experimental group but without hydrotherapy

Post-COVID Rehabilitation without hydrotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schön Klinik Berchtesgadener Land

Schönau am Königssee, Bavaria, 83471, Germany

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rembert Koczulla, MD

    Schön Klinik Berchtesgadener Land

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rainer Gloeckl, PhD

CONTACT

+498652931630rgloeckl@schoen-klinik.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The statistician that performs the final data analysis is blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 5, 2025

First Posted

June 10, 2025

Study Start

August 21, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)