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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047783
Receipt No. R000054476
Scientific Title Search for low-burden Fowler position conditions focusing on lower limb elevation and trunk posture
Date of disclosure of the study information 2022/05/18
Last modified on 2022/05/17

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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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