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| Name | Class |
|---|---|
| Karl and Veronica Carstens Foundation | OTHER |
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The goal of this randomized controlled trial is to learn about the effect of a hydrotherapeutic approach - a temperature-elevating armbath - in people with arterial hypertention. The main question[s] it aims to answer are:
Participants will be advised to perform a temperature-elevating armbath once a day for 30 minutes on at least 5 days per week over 8 weeks.
The comparison group will continue treatment as usual, like continue their medication. 24h blood pressure measurements will be performed at the beginning, after 8 weeks and after 6 months in both groups. The main goal is to evaluate whether the intervention group shows lower blood pressure levels after a certain time of treatment.
After 6 months (end of trial) the control group will be offered to learn the temperature elevating armbath as well.
Arterial hypertension remains one of the most important risk factors in developing a cardiovascular disease. While medical treatment is usually necessary, lifestyle modifications should always be included. Besides physical activity and a balanced diet, there are also therapeutic approaches from the so called classical complementary medicine. One very important part in Europe is hydrotherapy, based on ideas of Sebastian Kneipp and his contemporaries. In hydrotherapy there are various therapeutic approaches that can be used additionally to conventional therapy. Because conventional medical therapy is often associated with unwanted side effects, these additional approaches experience increasing popularity. In arterial hypertension, temperature-elevating armbaths, developed by Kneipps contemporaries Hauffe and Schwenninger, are a hydrotherapeutic approach that is highly recommended. Even though hydrotherapy has been a part of complementary medicine for more than a century now some therapeutic approaches lack of scientific evidence - especially when it comes to their effect on arterial hypertension.
This randomized-controlled trial aims to evaluate the effect of a temperature-elevating armbath among participants with arterial hypertension. 50 participants will be randomized to either an intervention group or waitlist (treatment as usual). All 50 participants will be monitored with three 24-hours ambulatory blood pressure measurements (24h ABPM) at the beginning of the trial after randomization, at 8 weeks and at 6 months.
The intervention group will be advised to perform the armbaths on 5 of 7 days per week for 8 weeks total. Each participant will get a detailed instruction how to perform the armbath and will be handed a diary to document their performance.
After 6 months, each participant of the control group will be offered to be instructed on performing the armbaths as well.
Within the active period of 8 weeks, participants of both groups will be called regularly to ask about their health and whether they have questions regarding the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Armbath | Experimental | The armbath group will perform a temperature-elevating armbath developed by Hauffe and Schwenninger. A large bowl and a thermometer will be given to each participant. Participant start with bathing their forearms up to about one third of the upper arm in a large bowl with water at approximately 37°C. Within 30min, they are advised to add hot water to the bowl for multiple times until a temperature of 42°C. After 30min, the arms can be taken out of the water, dried, and participants are recommended to rest for additional 30 min afterwards. Prior medication should be continued throughout the whole trial. |
|
| Waitlist | No Intervention | Participants will continue their treatment as usual (e.g. medication). After the end of the trial (6 months) they will be offered to get instructed on performing temperature-elevating armbaths. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| temperature-elevating armbath | Procedure | Hydrotherapeutic Approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | to 6 months | |
| SF-12 | Health-related quality of life | to 8 weeks and 6 months |
| PSQI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wiebke Kohl-Heckl, MD | Contact | 004920117425058 | w.kohl@kem-med.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kliniken Essen-Mitte | Recruiting | Essen | North Rhine-Westphalia | 45276 | Germany |
Blood pressure measurements, Comorbidities, medication
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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randomized controlled trial
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Sleep quality |
| to 8 weeks and 6 months |
| heartrate | to 8 weeks and 6 months |
| Adverse events | to 8 weeks and 6 months |
| Medication | Monitoring of changes in medication | to 8 weeks and 6 months |