Short time effects of armbaths on blood pressure in patients with hypertension - a randomized cross-over study
- Conditions
- I10.0
- Registration Number
- DRKS00024894
- Lead Sponsor
- nizentrum Naturheilkunde
- Brief Summary
Recruitment and sample description For assessment of eligibility and the randomization process see CONSORT flowchart (figure 1). Table 1 lists sociodemographic and anthropometric baseline characteristics of the study population. We found no significant differences between the two randomized arms AB and BA. The major part of the patients (68.52%) used antihypertensive medication, in decreasing order angiotensin receptor blockers (31.5%), ACE inhibitors (27,8%) and beta blockers (20,4%)/calcium channel blockers (20.4%). The medium duration of arterial hypertension was 8.5 years. In the ITT analysis we included 54 patients, 27 from each studyarm. Because of 4 withdrawals, PP data consisted of 50 patients. Evaluation of potential carryover effects We could exclude carryover effects for all parameters by analyzing the potential interaction of treatment and period. HAB When patients expressed discomfort or pain at a temperature of 45°C, we waited for a tolerable temperature. The range of the water temperature before the beginning of the HAB was from 41 to 46,2°C ( medium 45°C), immediately after ranging from 37 to 45°C (medium 41.4°C). The room temperature was ranging from 21 to 29°C (medium 25°C). TAB The water temperature at the beginning of the TAB was ranging from 27 to 30.4°C (medium 28°C ), after the TAB ranging from 25 to 30.5°C (medium 28°C). The room temperature during the TAB was ranging from 22 to 29°C (medium 25°C). Primary endpoint One minute after the interventions, DBP had decreased compared to the mean baseline value. The effect was bigger after the HAB compared to the TAB (3.89 mmHg (SD 9.74 mmHg) after the HAB vs. 1.24 mmHg (SD 5.74 mmHg) after the TAB), but the difference between the two interventions was not statistically significant (p=0.09). Secondary endpoints Blood pressure We found a decrease in SBP until 60 minutes post-intervention after both the HAB and the TAB. The effect was more pronounced after the HAB, but without being significant. After the HAB, DBP decreased until 60 minutes post-intervention. After the TAB, there was an increase in DBP at all time points except 30 minutes post-intervention. Differences were significant at 5, 10 and 15 minutes after the interventions, there was a medium effect size (5 minutes: HAB 4.82 mmHg (8.36), TAB -0.01 mmHg (5.85), p = 0.003, 95%-CI ?2.07; 7.59?, 10 minutes: HAB 3.28 mmHg (7.32), TAB -0.62 mmHg (6.96), p = 0.015, 95%-CI ?1.18; 6.63?, 15 minutes: HAB 3.38 mmHg (6.93), TAB -0.51 mmHg (6.02), p = 0.006, 95%-CI ?1.41; 6.37?). Heart rate Following the HAB, heart rate increased initially (1 minute post intervention), followed by a ongoing decrease. After the TAB, we found a decrease in heart rate at all time points. There was a significant difference between HAB and TAB one minute post-intervention (p=0.003*, 95%-CI ?-6.86; -2.05?). Hand and foot temperature We found an increase of hand temperature at all time points after the HAB, while there was a global decrease after the TAB. Differences were significant at 1, 5, 10, 15 and 30 minutes post-intervention. Changes in foot temperature weren't significant. Per Protocol Analysis A significant decrease in DBP was found 5, 10 and 15 minutes after HAB, heart rate increase was significant 1 and 5 minutes after HAB, and hand temperature was significantly higher 1, 5, 10, 15 and 30 minutes after HAB compared to TAB. Adverse events and tolerability Most patients rated the tolerability of the interventions as "very good" (50% after the HAB (n=12) vs. 46.2% after the TAB (n=12)) and "good" (45.8% after the HAB (n=11) vs. 50% after the TAB (n=13)). During the washout period there were reported chest pain six days after HAB (n=1) and sore throat and snoring after TAB (n=1) as adverse events. Dropouts and compliance After examination day 1 four patients (7.4%) withdrew, 3 from arm AB, one from arm BA. Two patients mentioned time constraints, the other two specified no special reasons. No patients changed their antihypertensive medication during the washout period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 54
women and men from the age of 18 years with arterial hypertonia and a blood pressure of >90mmHg diastolic and/or >150mmHg systolic at the first date of investigation
- sufficient knowledge of German to understand the information for the test person
- signed consent form to participate in the study, signed after detailed information
- diseases like cardiac insufficiency NYHA-stage 4, very advanced tumor diseases, ALS, dementia or psychiatric diseases, that could impede the correct implementation of the study
- blood pressure values, that are so elevated, that they need to be treated immediately in the opinion of the leader of the study
- expectation of life < 3 months
- eczema of the hands, that doesn't permit the implementation of hot arm baths
- strong polyneuropathy of the hands
- highly limited mobility
- pregnancy or lactation
- participation in another study in the last 4 weeks
- anamnestic drug use or alcohol abuse >60g/d in the last three months
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Do hot arm baths for five minutes, compared to thermoneutral arm baths for five minutes, lead to a reduction of the diastolic blood pressure measured immediately afterwards?<br>(measure with an electronic blood pressure monitor at the upper arm)
- Secondary Outcome Measures
Name Time Method - Do hot arm baths for five minutes, compared to thermoneutral arm baths for five minutes, lead to a reduction of the systolic and diastolic blood pressure measured after 0, 5, 10, 15, 30, 60, 90 minutes?<br>- Do hot arm baths for five minutes, compared to thermoneutral arm baths for five minutes, lead to a change of the pulse rate?<br>- Do hot arm baths for five minutes, compared to thermoneutral arm baths for five minutes, lead to a change of skin temperature of hands and feet?<br>- Do changes of the blood pressure correlate with changes of skin temperature of hands and/or feet?<br>(measure of blood pressure and pulse with an electronic blood pressure monitor at the upper arm, as well as a skin temperature measuring tool for the skin temperature)