Temperature-elevating Armbaths for Arterial Hypertension

NCT05928702 | Unknown

• 1 other identifier: WKHypertension
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Hypertension

Keywords

Complementary Medicine; Hydrotherapy

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  to 8 weeks

Secondary Outcomes (6)

• Blood pressure

  to 6 months

• SF-12

  to 8 weeks and 6 months

• PSQI

  to 8 weeks and 6 months

• heartrate

  to 8 weeks and 6 months

• Adverse events

  to 8 weeks and 6 months

Study Arms (2)

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.

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.

Interventions

temperature-elevating armbath PROCEDURE

Hydrotherapeutic Approach

Armbath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kliniken Essen-Mitte: lead
• Karl and Veronica Carstens Foundation: collaborator

Study Sites (1)

Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45276, Germany

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Wiebke Kohl-Heckl, MD

CONTACT

004920117425058; w.kohl@kem-med.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 3, 2023
• Study Start: June 23, 2023
• Primary Completion: December 23, 2023
• Study Completion: June 24, 2024
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)