UMIN-CTR Clinical Trial

Basic information
Public title	Search for low-burden Fowler position conditions focusing on lower limb elevation and trunk posture
Acronym	Searching for Fowler's position conditions with less burden
Scientific Title	Search for low-burden Fowler position conditions focusing on lower limb elevation and trunk posture
Scientific Title:Acronym	Searching for conditions of low-burden Fowler's position
Region	Japan

Condition
Condition	Healthy adult and Healthy elderly
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to clarify the detailed angular conditions of the Fowler's position, which is a low burden position for the circulatory system. In addition, the purpose of this study is to clarify the effectiveness of foot elevation in the Fowler's position. The purpose of this study is to clarify the usefulness of the upper trunk flexion posture, including not only the Fowler's posture but also the lower trunk angle such as the semi-Fowler's posture, and whether the combination of lower limb elevation is useful.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The main outcome measure is the calculation of single-beat output, cardiac output, and heart rate to evaluate the differences in circulatory dynamics in each of the set postures. The single beat ejection fraction will be calculated from the left ventricular ejection time calculated from the chest impedance and heart sounds using the method of Bernstein et al. The heart rate is calculated from the electrocardiogram. Cardiac output is calculated from the product of single beat volume and heart rate.
Key secondary outcomes	From the continuous blood pressure, the blood pressure in each posture (systolic, diastolic, and mean blood pressure) is calculated. From mean blood pressure and cardiac output, peripheral vascular resistance can be calculated. In the elderly, arterial stiffness, decreased vagal activity, and decreased sensitivity to the vagal baroreceptor reflex occur. Therefore, it is expected that there will be differences in the way the circulation is regulated during the Farrar position between the young and the elderly. In this study, we will calculate the index of vagal modulation from heart rate variability analysis. From RR interval and continuous blood pressure, baroreceptor reflex sensitivity (sequence method) will be calculated. To examine the effect of aging on arterial stiffness, the Arterial Pressure volume Index (API), an index of arterial stiffness in the upper arm, is calculated from the reflected waves of a pressurized upper arm cuff. In addition, to evaluate the effect of postural changes and blood movement on abdominal compliance, we will measure the push-in reaction force of the abdomen using a biotissue hardness tester.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver Other
Interventions/Control_1	Subjects must be able-bodied individuals who are able to obtain free and voluntary consent to participate in the research in writing from themselves. Subjects must be at least 20 years of age at the time consent is obtained.
Interventions/Control_2	Subjects must have a history of circulatory, respiratory, gastrointestinal, urological, or back pain disease, including surgery, in the past 5 years. The subject is currently in need of continuous hospital visits and medication. Subjects have difficulty in obtaining free written consent for participation in the study.
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	28 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects must be able-bodied individuals who are able to obtain free and voluntary consent to participate in the research in writing from themselves. Subjects must be at least 20 years of age at the time consent is obtained.
Key exclusion criteria	Subjects must have a history of circulatory, respiratory, gastrointestinal, urological, or back pain disease, including surgery, in the past 5 years. The subject is currently in need of continuous hospital visits and medication. Subjects have difficulty in obtaining free written consent for participation in the study.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name takuya Middle name Last name furudate
Organization	School of Nursing and Rehabilitation Science at Odawara, International University of Health and Welfare.
Division name	Department of Occupational Therapy
Zip code	250-8588
Address	1-2-25 Shiroyama, Odawara-shi, Kanagawa
TEL	0465210361
Email	t-furudate@iuhw.ac.jp

Public contact
Name of contact person	1st name takuya Middle name Last name furudate
Organization	International University of Health and Welfare
Division name	Department of Occupational Therapy
Zip code	250-8588
Address	1-2-25 Shiroyama, Odawara-shi, Kanagawa
TEL	0465210361
Homepage URL
Email	t-furudate@iuhw.ac.jp

Sponsor
Institute	International University of Health and Welfare
Institute
Department

Funding Source
Organization	ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	International University of Health and Welfare
Address	1-2-25 Shiroyama, Odawara-shi, Kanagawa
Tel	0465210361
Email	t-furudate@iuhw.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	2022 Year 05 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	Open public recruiting
Date of protocol fixation	2021 Year 07 Month 01 Day
Date of IRB	2021 Year 08 Month 11 Day
Anticipated trial start date	2021 Year 09 Month 01 Day
Last follow-up date	2022 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 05 Month 17 Day
Last modified on	2022 Year 05 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054476

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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