EVALUATION OF ANTIHYPERTENSIVE EFFECTS OF FREQUENT thermoneutral BATHS, A RANDOMIZED CONTROLLED TRIA
- Conditions
- I10.0
- Registration Number
- DRKS00003980
- Lead Sponsor
- niversitätsklinikum Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 59
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,
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Other parameters of the 24-hour-RR measurement, additional RR measurements of the diary, weight, waist circumference<br>Number of responders (RR = reduction by more than 5 mmHg or reduction of medication antihypertensiven)<br>Additional laboratory parameters (BB, sodium, potassium, creatinine, CK, chol, CRP,<br>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.<br>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.<br>In addition, detection of potential problems and acceptance of therapy baths and the control treatment.<br>Adverse events.<br>Influence of the frequency and duration of the baths.<br>Subgroups that benefit most from therapy (gender, age)