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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Healthy adult and Healthy elderly | ||
Classification by specialty |
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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 |
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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. |
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Interventions/Control_3 | ||||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
t-furudate@iuhw.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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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 |
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 | |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Recruitment status | Open public recruiting | ||||||
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Last modified on |
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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 | |
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Research case data | |
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