UMIN-CTR Clinical Trial

Basic information
Public title	Concurrent validity of the Sit-up test for assessing orthostatic changes in hemodynamics in healthy adults
Acronym	Concurrent validity of the Sit-up test for assessing orthostatic changes in hemodynamics in healthy adults
Scientific Title	Concurrent validity of the Sit-up test for assessing orthostatic changes in hemodynamics in healthy adults
Scientific Title:Acronym	Concurrent validity of the Sit-up test for assessing orthostatic changes in hemodynamics in healthy adults
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the concurrent validity of a Sit-up test against a head-up tilt test for assessing the orthostatic changes in blood pressure and hemodynamics in healthy adults.
Basic objectives2	Others
Basic objectives -Others	The purpose of this study is to examine the concurrent validity of a Sit-up test against a head-up tilt test for assessing the orthostatic changes in blood pressure and hemodynamics in healthy adults. This study may contribute to establishing the assessment method of orthostatic hypotension that is available with or without a tilt bed and regardless of standing ability.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Systolic blood pressure
Key secondary outcomes	Diastolic blood pressure Mean arterial pressure Heart rate Stroke volume Cardiac output Heart rate variability Baroreflex sensitivity Symptoms of orthostatic hypotension

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	40 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Able to perform activities of daily living independently 2.Consent to participate in this study
Key exclusion criteria	1.Limited range of motion and/or pain that affect the sit-up and head-up tilt tests 2.Neurologic conditions and/or spinal cord injury 3.Uncontrolled hypertension and/or diabetes mellitus 4.Inappropriate patients due to other reasons
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kazuaki Middle name Last name Oyake
Organization	Shinshu University
Division name	Department of Physical Therapy
Zip code	390-8621
Address	3-1-1 Asahi, Matsumoto, Nagano
TEL	0263-37-2413
Email	k_oyake@shunshu-u.ac.jp

Public contact
Name of contact person	1st name Kazuaki Middle name Last name Oyake
Organization	Shinshu University
Division name	Department of Physical Therapy
Zip code	390-8621
Address	3-1-1 Asahi, Matsumoto, Nagano
TEL	0263-37-2413
Homepage URL
Email	k_oyake@shunshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

Funding Source
Organization	Shinshu University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokyo Bay Rehabilitation Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics committee of Shinshu University
Address	3-1-1 Asahi, Matsumoto, Nagano
Tel	0263-37-2572
Email	mdrinri@shinshu-u.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	信州大学（長野県） 東京湾岸リハビリテーション病院（千葉県）

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	18
Results	There were significant correlations between the tests for orthostatic changes in systolic blood pressure, diastolic blood pressure, and heart rate. Compared to the head-up tilt test, the sit-up test showed the smaller decrease in systolic blood pressure, the larger increase in diastolic blood pressure, and the smaller increase in heart rate during testing.
Results date posted	2021 Year 01 Month 16 Day
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	Completed
Date of protocol fixation	2020 Year 01 Month 10 Day
Date of IRB	2020 Year 01 Month 10 Day
Anticipated trial start date	2020 Year 01 Month 20 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We examine the correlations and the differences of the orthostatic changes in hemodynamics between the head-up tilt test and the sit-up test.

Management information
Registered date	2020 Year 01 Month 16 Day
Last modified on	2021 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044682