UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the effect of foot baths using commercially available carbonated bath salts on the hemodynamics of patients with heart disease
Acronym	Examination of the effect of foot baths using commercially available carbonated bath salts on the hemodynamics of patients with heart disease
Scientific Title	Examination of the effect of foot baths using commercially available carbonated bath salts on the hemodynamics of patients with heart disease
Scientific Title:Acronym	Examination of the effect of foot baths using commercially available carbonated bath salts on the hemodynamics of patients with heart disease
Region	Japan

Condition
Condition	heart disease
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of hemodynamics on patients with heart disease by using a foot bath using a commercially available carbonated bath salt using subjective and objective indicators. The purpose of this is to provide information that contributes to the care methods implemented by supporters such as patients, nurses, and caregivers.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in vital signs (blood pressure, pulse, SpO2, heart rate, electrocardiogram) from start to end of footbath compared to resting before implementation.
Key secondary outcomes	Changes in Body Composition Analyzer (In Body) measurements during the implementation period. Changes in thermography measurements during the implementation period. Changes in oil and moisture measurements before and after implementation.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Adults over 20 years of age with heart disease, AHA / ACC heart failure Stage C stage, NYHA I, II symptoms and LVEF 40% or higher. Patients who can maintain a sitting position. Patients who have permission to take a foot bath from their doctor.
Key exclusion criteria	Those who have been diagnosed with dementia, or who have an in-hospital CGA evaluation and have an MMSE of 23 points or less. Those who are infusing circulatory drugs.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kikuko Middle name Last name Yamashita
Organization	Shiga University of Medical Science Hospital
Division name	Nursing Department
Zip code	5202192
Address	Seta Tsukinowa-cho, Otsu, Shiga
TEL	0775482111
Email	tsunsan@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Kikuko Middle name Last name Yamashita
Organization	Shiga University of Medical Science Hospital
Division name	Nursing Department
Zip code	5202192
Address	Seta Tsukinowa-cho, Otsu, Shiga
TEL	0775482111
Homepage URL
Email	tsunsan@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shiga University of Medical Science Research Ethics Committee
Address	Seta Tsukinowa-cho, Otsu, Shiga
Tel	0775483576
Email	hqrec@belle.shiga-med.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2021 Year 01 Month 27 Day
Date of IRB	2021 Year 01 Month 27 Day
Anticipated trial start date	2021 Year 02 Month 18 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is an exploratory study. The registration period is until December 31, 2021. Among the patients admitted to cardiology / cardiovascular surgery during the period, the researchers will give an oral explanation in writing and obtain written consent for patients who meet the eligibility criteria.

Management information
Registered date	2021 Year 02 Month 17 Day
Last modified on	2021 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049507

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.