Skip to content

EVALUATION OF ANTIHYPERTENSIVE EFFECTS OF FREQUENT thermoneutral BATHS, A RANDOMIZED CONTROLLED TRIAL

EVALUATION OF ANTIHYPERTENSIVE EFFECTS OF FREQUENT thermoneutral BATHS, A RANDOMIZED CONTROLLED TRIAL - ASCLEPIOS (ASSESSING CLINICAL EFFECTS OF PHYSIOLOGICAL IMMERSION IN HYPERTENSIVE SUBJECTS)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00003980
Enrollment
60
Registered
2012-07-10
Start date
2012-07-23
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I10.0

Interventions

Group 1: 24 weeks 4 baths per week in thermo-neutral water for 60 minutes Group 2: 4 weeks 4 baths per week, 20 weeks 1 bath per week in thermo-neutral water for 60 minutes Group 3: 24 weeks non-drug

Sponsors

Universitätsklinikum Freiburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Known Arterial Hypertension • Blood pressure: systolic RR 140-180, 90-110 diastolic (hypertension grade 1 and 2), with and without antihypertensive drugs, •> 18 years • existence of a written consent of the patient • sufficient knowledge of German for questionnaires, and being able to perform an ambulatory RR-measurement • Willingness and ability to perform over 26 weeks 4 baths per week, or relaxation exercises,

Exclusion criteria

Exclusion criteria: Participation in other interventional trials • risk factors, organ damage, DM, metabolic syndrome are no exclusion criteria per se, but only • heart failure class III and IV (clinical, echocardiographic in doubt and / or verified by BNP) • Grade IV PAD (clinically confirmed if necessary Doppler or duplex • renal failure, creatinine> 1.5 mg / dl • acute infection, fever • Unstable AP • or very severe disease • change in antihypertensive medication last 4 weeks • Secondary hypertension indication for treatment with antihypertensive drugs other than (further clarification necessary only for clear indications, such as hypokalemia, flushing, etc.) • The need for a change of antihypertensive medication in the next 4 weeks • reasons to exclude the public bath (open wounds or similar) • Regular baths (> 1 per week) in past 2 months • Pregnancy

Design outcomes

Primary

MeasureTime frame
morning blood pressure and 24-hour-RR measurement (diastolic, systolic, and MAP) before treatment, after 4 weeks of therapy and after 24 weeks of therapy

Secondary

MeasureTime frame
Other parameters of the 24-hour-RR measurement, additional RR measurements of the diary, weight, waist circumference Number of responders (RR = reduction by more than 5 mmHg or reduction of medication antihypertensiven) Additional laboratory parameters (BB, sodium, potassium, creatinine, CK, chol, CRP, Aldosterone, renin, angiotensin, N-präANP, cortisol in hair), should provide clues to the mode of action of the baths. Blood is taken on scheduled dates. Through questionnaires (SF36, PSQ, own questionnaire) to be detected in as much relaxation, stress reduction, quality of life or other subjective parameters can explain the effect. In addition, detection of potential problems and acceptance of therapy baths and the control treatment. Adverse events. Influence of the frequency and duration of the baths. Subgroups that benefit most from therapy (gender, age)

Countries

Germany

Contacts

Public ContactJohannes Naumann

IBF Balneologie der Uniklinik Freiburg

johannes.naumann@uniklinik-freiburg.de0049-7633-4008-502

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 1, 2026