Temperature-dependent Changes in Cardiovascular Parameters During Warm Water Footbaths in Healthy Women

NCT04579497 | Completed

• 1 other identifier: SWI_16
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

A study to explore whether different temperatures of warm water footbaths have different effects on the cardiovascular system, the autonomic nervous system and the general well-being of healthy women.

Conditions

Warm Footbath; Cardiovascular System; Autonomic Nervous System

Keywords

Warm water footbath; Temperature-dependent effects; Cardiovascular System; Autonomic Nervous System; Heart Rate Variability; Healthy female volunteers

Outcome Measures

Primary Outcomes (1)

• Pressure Rate Product (PRP) at timepoint t5 (footbath minute 21-30)

  Pressure Rate Product (PRP), calculated from systolic blood pressure (measured with the Mobil-O-Graph® PWA) and heart rate (measured with the Bittium Faros 360TM ECG recorder) at timepoint 5 (t5 = mean of the measurements recorded from minute 21 to minute 30 of the footbath).

  Timepoint 5 (t5 = mean of the measurements recorded from minute 21-30 of the 30-minute footbath)

Secondary Outcomes (52)

• Change in Pressure Rate Product (PRP) at timepoints t1 (minute 1-10 of the pre-intervention rest period), t3 (minute 1-10 of the footbath), t4 (minute 11-20 of the footbath), and t7 (minute 1-10 of the post-intervention rest period).

  Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

• Heart rate variability (HRV) analysis: Change in SDNN

  Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

• Change in pNN50

  Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

• Change in HF

  Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

• Change in LF

  Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

Other Outcomes (2)

• Change in warmth perception and skin stimulus at the feet during the footbath

  Up to 30 minutes.

• Preferred footbath

  10 minutes.

Study Arms (4)

38° C footbath

EXPERIMENTAL

Footbath with warm water at a constant temperature of 38° C

Other: 38°C warm water footbath

40° C footbath

EXPERIMENTAL

Footbath with warm water at a constant temperature of 40° C

Other: 40°C warm water footbath

42° C footbath

EXPERIMENTAL

Footbath with warm water at a constant temperature of 42° C

Other: 42°C warm water footbath

Rising temperature footbath

EXPERIMENTAL

Footbath with warm water rising from 38° C to 42° C

Other: 38-42°C rising temperature footbath

Interventions

38°C warm water footbath OTHER

A ten-minute pre-intervention rest period followed by a 30-minute footbath with 16 l of warm water at a constant temperature of 38°C, followed by a ten-minute post-intervention rest period.

38° C footbath

40°C warm water footbath OTHER

A ten-minute pre-intervention rest period followed by a 30-minute footbath with 16 l of warm water at a constant temperature of 40°C, followed by a ten-minute post-intervention rest period.

40° C footbath

42°C warm water footbath OTHER

A ten-minute pre-intervention rest period followed by a 30-minute footbath with 16 l of warm water at a constant temperature of 42°C, followed by a ten-minute post-intervention rest period.

42° C footbath

38-42°C rising temperature footbath OTHER

A ten-minute pre-intervention rest period followed by a 30-minute footbath with 16 l of warm water. Water temperature starts at 38°C and is increased by 1°C every 6 minutes, resulting in 42°C after 30 minutes. The footbath is followed by a ten-minute post-intervention rest period.

Rising temperature footbath

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent
• Age between 18 and 55 years

You may not qualify if:

• Male sex
• Chronic skin lesions at the lower legs or feet
• Varicose veins grade 3 and grade 4 (Marshall stage classification), chronic venous insufficiency
• Cardiac arrhythmia
• Cardiac pacemaker
• Asthma bronchiale
• Consumption of HRV-modulating medication (especially tricyclic antidepressants, beta blockers)
• Pregnancy
• Insufficient knowledge of the German language

Sponsors & Collaborators

• ARCIM Institute Academic Research in Complementary and Integrative Medicine: lead
• Universität Tübingen: collaborator

Study Sites (1)

Arcim Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

Study Officials

• Jan Vagedes, Dr

  Arcim Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 8, 2020
• Study Start: October 26, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be made available upon publication for a duration of three months.
• Access Criteria: The data will be made available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.

Locations

DE (1)