Arterial HypertensionNCT05928702
Temperature-elevating Armbaths for Arterial Hypertension
A study testing temperature-elevating armbath in people with Arterial Hypertension, run by Kliniken Essen-Mitte at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Hypertension
- What is being tested?
- temperature-elevating armbath
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 23 Jun 2023to 24 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult participants (≥18 years)
- diagnosed arterial hypertension, at least stage I, based on the Guidelines of the European Society of Hypertension 2018 (systolic >140 mmHg, diastolic >90 mmHg)
- last change in medication at least 2 months ago
- no planned changes in blood pressure medication within intervention time; changes due to medical reasons (e.g., hypotension, hypertensive emergency) are allowed.
- willingness to perform an armbath on a regular schedule (min. 5x/weeks)
Who cannot join
- acute psychiatric disease ( e.g., addiction, major depression)
- acute or major physical disease (e.g., cancer diagnosis within the last 5 years, major known cardiovascular diseases, renal or liver dysfunction), acute infection, major neurological diseases (e.g., Parkinsons´ disease, uncontrolled epilepsy)
- secondary hypertension
- pregnancy or lactation period
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, 45276
Wiebke Kohl-Heckl, 004920117425058, w.kohl@kem-med.com
About this study
Official title: The Effect of Temperature-elevating Armbaths (Hauffe-Schwenniger-Baths) as a Therapeutic Option to Regulate the Blood Pressure in People With Arterial Hypertension - a Randomized-controlled Trial (Wirksamkeit Temperaturansteigender Armbäder (Hauffe-Schweninger Bäder) Zur Regulierung Des Blutdrucks Bei Probanden Mit Arterieller Hypertonie - Eine Randomisiert-kontrollierte Studie)
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:
- Can this kind of hydrotherapy lower the blood pressure and therefore be an additional approach to medical treatment in arterial hypertension?
- Besides blood pressure regulation, does this intervention affect sleep quality when being performed at night time or does it affect overall quality of life?
Read more
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.
Read the detailed description
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.
- Conditions
- Arterial Hypertension
- Being tested
- temperature-elevating armbath
- Keywords
- Complementary Medicine, Hydrotherapy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temperature-elevating armbathProcedure or surgery
Hydrotherapeutic Approach
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: temperature-elevating armbath |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: to 8 weeks
Secondary outcomes (6)
Blood pressure
Measured: to 6 months
SF-12
Health-related quality of life
Measured: to 8 weeks and 6 months
PSQI
Sleep quality
Measured: to 8 weeks and 6 months
heartrate
Measured: to 8 weeks and 6 months
Adverse events
Measured: to 8 weeks and 6 months
Medication
Monitoring of changes in medication
Measured: to 8 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start23 Jun 2023
- Primary completion23 Dec 2023 (estimated)
- Study completion24 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kliniken Essen-Mitte
- Sponsor type
- University, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation
- Responsible party
- Principal investigator, Kohl, Wiebke, Kliniken Essen-Mitte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928702
- Sponsor's protocol ID
- WKHypertension
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Blood pressure measurements, Comorbidities, medication
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Temperature-elevating Armbaths (Hauffe-Schwenniger-Baths) as a Therapeutic Option to Regulate the Blood Pressure in People With Arterial Hypertension - a Randomized-controlled Trial (Wirksamkeit Temperaturansteigender Armbäder (Hauffe-Schweninger Bäder) Zur Regulierung Des Blutdrucks Bei Probanden Mit Arterieller Hypertonie - Eine Randomisiert-kontrollierte Studie)
- ClinicalTrials.gov ID
- NCT05928702
- Acronym / sponsor ID
- WKHypertension
- Conditions
- Arterial Hypertension
- Keywords
- Complementary Medicine, Hydrotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kliniken Essen-MitteUniversity, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 23 Dec 2023 (estimated)
- Study completion
- 24 Jun 2024 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can this kind of hydrotherapy lower the blood pressure and therefore be an additional approach to medical treatment in arterial hypertension?
- Besides blood pressure regulation, does this intervention affect sleep quality when being performed at night time or does it affect overall quality of life?
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Armbath | Experimental | Procedure: temperature-elevating armbathThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult participants (≥18 years)
- diagnosed arterial hypertension, at least stage I, based on the Guidelines of the European Society of Hypertension 2018 (systolic >140 mmHg, diastolic >90 mmHg)
- last change in medication at least 2 months ago
- no planned changes in blood pressure medication within intervention time; changes due to medical reasons (e.g., hypotension, hypertensive emergency) are allowed.
- willingness to perform an armbath on a regular schedule (min. 5x/weeks)
Key exclusion criteria (4 listed)
- acute psychiatric disease ( e.g., addiction, major depression)
- acute or major physical disease (e.g., cancer diagnosis within the last 5 years, major known cardiovascular diseases, renal or liver dysfunction), acute infection, major neurological diseases (e.g., Parkinsons´ disease, uncontrolled epilepsy)
- secondary hypertension
- pregnancy or lactation period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| temperature-elevating armbathHydrotherapeutic Approach | Procedure or surgery | Armbath |
Primary outcome
Blood pressure
Time frame: to 8 weeks
6 secondary outcomes
Blood pressure
Time frame: to 6 months
SF-12
Time frame: to 8 weeks and 6 months
PSQI
Time frame: to 8 weeks and 6 months
heartrate
Time frame: to 8 weeks and 6 months
Adverse events
Time frame: to 8 weeks and 6 months
Medication
Time frame: to 8 weeks and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No. Blood pressure measurements, Comorbidities, medication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing temperature-elevating armbath in people with Arterial Hypertension, run by Kliniken Essen-Mitte at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wiebke Kohl-Heckl, MD (004920117425058, w.kohl@kem-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.