UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047783 |
|---|---|
| Receipt number | 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 21:59:23 |
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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
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
t-furudate@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054476
