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Temperature-elevating Armbaths for Arterial Hypertension

Primary Purpose

Arterial Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
temperature-elevating armbath
Sponsored by
Kliniken Essen-Mitte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Hypertension focused on measuring Complementary Medicine, Hydrotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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

Sites / Locations

  • Kliniken Essen-MitteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Armbath

Waitlist

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Blood pressure

Secondary Outcome Measures

Blood pressure
SF-12
Health-related quality of life
PSQI
Sleep quality
heartrate
Adverse events
Medication
Monitoring of changes in medication

Full Information

First Posted
June 23, 2023
Last Updated
June 23, 2023
Sponsor
Kliniken Essen-Mitte
Collaborators
Karl and Veronica Carstens Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05928702
Brief Title
Temperature-elevating Armbaths for Arterial Hypertension
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2023 (Actual)
Primary Completion Date
December 23, 2023 (Anticipated)
Study Completion Date
June 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kliniken Essen-Mitte
Collaborators
Karl and Veronica Carstens Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypertension
Keywords
Complementary Medicine, Hydrotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Armbath
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
temperature-elevating armbath
Intervention Description
Hydrotherapeutic Approach
Primary Outcome Measure Information:
Title
Blood pressure
Time Frame
to 8 weeks
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
to 6 months
Title
SF-12
Description
Health-related quality of life
Time Frame
to 8 weeks and 6 months
Title
PSQI
Description
Sleep quality
Time Frame
to 8 weeks and 6 months
Title
heartrate
Time Frame
to 8 weeks and 6 months
Title
Adverse events
Time Frame
to 8 weeks and 6 months
Title
Medication
Description
Monitoring of changes in medication
Time Frame
to 8 weeks and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wiebke Kohl-Heckl, MD
Phone
004920117425058
Email
w.kohl@kem-med.com
Facility Information:
Facility Name
Kliniken Essen-Mitte
City
Essen
State/Province
North-Rhine-Westphalia
ZIP/Postal Code
45276
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wiebke Kohl-Heckl
Phone
004920117425058
Email
w.kohl@kem-med.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Blood pressure measurements, Comorbidities, medication

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Temperature-elevating Armbaths for Arterial Hypertension

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