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

July 15, 2021 updated by: ARCIM Institute Academic Research in Complementary and Integrative Medicine

Temperature-dependent Changes in Cardiovascular Parameters During Warm Water Footbaths in Healthy Female Volunteers - a Blinded, Randomized, Controlled, Four-arm Study With Cross-over Design

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a blinded, four-arm randomized controlled trial with crossover design to explore the effects of warm water footbaths with different water temperatures on cardiovascular stress, reaction of the autonomic nervous system and a feeling of comfort and warmth in healthy female volunteers. Cardiovascular and ANS measurements are performed continuously throughout the interventions and the participants rate their feelings of warmth, general well-being and the footbath-related comfort with questionnaires.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Filderstadt, Baden-Württemberg, Germany, 70794
        • ARCIM Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Written informed consent
  • Age between 18 and 55 years

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 38° C footbath
Footbath with warm water at a constant temperature of 38° C
Other: 38°C warm water footbath
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.
EXPERIMENTAL: 40° C footbath
Footbath with warm water at a constant temperature of 40° C
Other: 40°C warm water footbath
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.
EXPERIMENTAL: 42° C footbath
Footbath with warm water at a constant temperature of 42° C
Other: 42°C warm water footbath
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.
EXPERIMENTAL: Rising temperature footbath
Footbath with warm water rising from 38° C to 42° C
Other: 38-42°C rising temperature footbath
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pressure Rate Product (PRP) at timepoint t5 (footbath minute 21-30)
Time Frame: Timepoint 5 (t5 = mean of the measurements recorded from minute 21-30 of the 30-minute footbath)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 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.
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 timepoints t1 (t1 = mean of the measurements recorded from minute 1 to minute 10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1 to minute 10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11 to minute 20 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1 to minute 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
Time Frame: 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.
SDNN: Standard deviation of normal to normal (NN) intervals (ms) (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in pNN50
Time Frame: 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.
pNN50: Percentage of successive NN intervals that differ from each other by more than 50 ms (%) (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in HF
Time Frame: 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.
HF: High frequency power band (0.15-0.40 Hz) (ms2) from frequency domain analysis (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in LF
Time Frame: 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.
LF: Low frequency power band (0.04-0.15 Hz) (ms2) from frequency domain analysis (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in LF/HF ratio
Time Frame: 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.
LF/HF ratio = ratio of two bands from frequency domain analysis: LF band (0.04-0.15 Hz), HF band (0.15-0.40 Hz) (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in VLF
Time Frame: 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.
VLF: Very low frequency power band (0.0033-0.04 Hz) (ms2) from frequency domain analysis (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Mean Heart Rate
Time Frame: 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.
Mean heart rate (bpm) (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in SD2/SD1 ratio
Time Frame: 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.
SD2/SD1 ratio, derived from Poincaré plot (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Stress Index
Time Frame: 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.
Stress Index (SI) according to Baevsky's formula SI = AMo/2Mo*MxDMn (Mo = mode, AMo = mode amplitude, MxDMn = variation range of RR intervals) (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Respiration Rate
Time Frame: 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.
Respiration rate (1/min) (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Heart Rate/Respiration Rate ratio
Time Frame: 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/respiration rate ratio (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in RMSSD
Time Frame: 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.
RMSSD: Root mean square of successive differences (ms) (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Stiffness Index
Time Frame: 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.
Stiffness Index, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Perfusion Index
Time Frame: 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.
Perfusion Index, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Peak to Peak Time
Time Frame: 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.
Peak to Peak Time (PPT, ms), measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in SlopeInW1
Time Frame: 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.
SlopeInW1, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in SlopeInW2
Time Frame: 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.
SlopeInW2, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in SlopeInW3
Time Frame: 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.
SlopeInW3, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in SlopeInW4
Time Frame: 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.
SlopeInW4, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Reflection Index
Time Frame: 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.
Reflection Index, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in TimeTX
Time Frame: 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.
TimeTX (ms), measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in TimeTY
Time Frame: 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.
TimeTY (ms), measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in QuotTYTX
Time Frame: 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.
QuotTYTX, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in AreaAX
Time Frame: 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.
AreaAX, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in AreaAY
Time Frame: 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.
AreaAY, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in QuotAYAX
Time Frame: 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.
QuotAYAX, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in TimeTV
Time Frame: 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.
TimeTV (ms), measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in TimeTW
Time Frame: 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.
TimeTW (ms), measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in QuotTVTW
Time Frame: 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.
QuotTVTW, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in AreaAV
Time Frame: 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.
AreaAV, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in AreaAW
Time Frame: 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.
AreaAW, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in QuotAVAW
Time Frame: 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.
QuotAVAW, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Oxygen Saturation
Time Frame: 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.
Oxygen saturation (SpO2, %), measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Pulse Transit Time
Time Frame: 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.
Pulse Transit Time (PTT, ms), measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Systolic Blood Pressure
Time Frame: 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.
Systolic Blood Pressure (mmHg), measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Diastolic Blood Pressure
Time Frame: 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.
Diastolic Blood Pressure (mmHg), measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Mean Arterial Pressure
Time Frame: 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.
Mean Arterial Pressure (mmHg), measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Pulse Pressure
Time Frame: 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.
Pulse Pressure (mmHg), measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Stroke Volume
Time Frame: 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.
Stroke Volume (ml), measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Cardiac Output
Time Frame: 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.
Cardiac Output (l/min), measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Peripheral Resistance
Time Frame: 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.
Peripheral Resistance, measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Cardiac Index
Time Frame: 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.
Cardiac Index, measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Augmentation Pressure
Time Frame: 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.
Augmentation Pressure (mmHg), measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Augmentation Index
Time Frame: 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.
Augmentation Index, measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in Pulse Wave Velocity
Time Frame: 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.
Pulse Wave Velocity (PWV, m/s), measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from 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.
Change in warmth perception at the feet
Time Frame: Immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8) (length of footbath is up to 30 minutes).
Self-reported warmth perception at both feet, assessed with the "Herdecke warmth perception questionnaire" immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8). Each item is scored 0-4 (0 = cold; 4 = hot), yielding a mean between 0 and 4.
Immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8) (length of footbath is up to 30 minutes).
Change in warmth perception at the hands
Time Frame: Immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8) (length of footbath is up to 30 minutes).
Self-reported warmth perception at both hands, assessed with the "Herdecke warmth perception questionnaire" immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8). Each item is scored 0-4 (0 = cold; 4 = hot), yielding a mean between 0 and 4.
Immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8) (length of footbath is up to 30 minutes).
Change in warmth perception at the head
Time Frame: Immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8) (length of footbath is up to 30 minutes).
Self-reported warmth perception at the head, assessed with the "Herdecke warmth perception questionnaire" immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8). Each item is scored 0-4 (0 = cold; 4 = hot), yielding a mean between 0 and 4.
Immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8) (length of footbath is up to 30 minutes).
Change in overall warmth perception
Time Frame: Immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8) (length of footbath is up to 30 minutes).
Self-reported overall warmth perception, assessed with the "Herdecke warmth perception questionnaire" immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8). The item is scored 0-4 (0 = cold; 4 = hot).
Immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8) (length of footbath is up to 30 minutes).
Change in general well-being
Time Frame: Immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8) (length of footbath is up to 30 minutes).
Self-reported well-being, assessed with the "Basler Befindlichkeits-Skala" (Basel Mood Questionnaire, BBS) immediately before (t2), immediately after (t6) and 10 minutes following the footbath (t8) (BBS: 16 items; 7-point rating scale; higher values represent a better outcome).
Immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8) (length of footbath is up to 30 minutes).
Change in feeling of comfort during footbath
Time Frame: Immediately before the footbath (timepoint 2, t2), every 6 minutes during the 30-minute footbath, and 10 minutes following the footbath (timepoint 8, t8).
Self-reported footbath comfort, assessed with a 7-point face scale ranging from "very comfortable" (laughing face) to "very hard stress" (crying face).
Immediately before the footbath (timepoint 2, t2), every 6 minutes during the 30-minute footbath, and 10 minutes following the footbath (timepoint 8, t8).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in warmth perception and skin stimulus at the feet during the footbath
Time Frame: Up to 30 minutes.
Self-reported perception of warmth and skin stimulus during the footbath, assessed with a dynamic warmth and skin stimulus visual analog scale (VAS), applied once per minute (0 = cold/no stimulus; 10 = very hot/very strong stimulus).
Up to 30 minutes.
Preferred footbath
Time Frame: 10 minutes.
Self-reported personal preference of footbath, assessed with a short questionnaire asking which footbath had the most positive overall effect (check boxes to mark for the first, second, third, or fourth footbath) and why (short, self-formulated statement of reasons). Assessed once after the fourth footbath intervention.
10 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universität Tübingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SWI_16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.

IPD Sharing Time Frame

The data will be made available upon publication for a duration of three months.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings