UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059866 |
|---|---|
| Receipt number | R000068458 |
| Scientific Title | New indices of arterial stiffness measured with an upper-arm oscillometric device in lifelong Japanese practitioners of tradi-tional vocal recitation: a pilot hypothesis-generating study |
| Date of disclosure of the study information | 2025/11/24 |
| Last modified on | 2025/11/24 09:29:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
New indices of arterial stiffness measured with an upper-arm oscillometric device in lifelong Japanese practitioners of tradi-tional vocal recitation: a pilot hypothesis-generating study
Acronym
New indices of arterial stiffness measured with an upper-arm oscillometric device in lifelong Japanese practitioners of tradi-tional vocal recitation: a pilot hypothesis-generating study
Scientific Title
New indices of arterial stiffness measured with an upper-arm oscillometric device in lifelong Japanese practitioners of tradi-tional vocal recitation: a pilot hypothesis-generating study
Scientific Title:Acronym
New indices of arterial stiffness measured with an upper-arm oscillometric device in lifelong Japanese practitioners of tradi-tional vocal recitation: a pilot hypothesis-generating study
Region
| Japan |
Condition
Condition
None (Observational study in community-dwelling middle-aged and older adults)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine whether long-term practice of traditional Japanese vocal recitation (shigin) is associated with arterial stiffness indices - arterial velocity pulse index (AVI) and arterial pressure volume index (API) - and to explore relationships with respiratory function (PEF) and a stress biomarker (salivary alpha-amylase).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Arterial velocity pulse index (AVI)
Arterial pressure volume index (API)
Key secondary outcomes
Brachial and central blood pressure (SBP, DBP, MBP, CSBP)
Resting heart rate
Peak expiratory flow (PEF)
Salivary alpha-amylase
Daily physical activity (steps and energy expenditure)
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Community-dwelling adults aged 50 years or older
Individuals who have received an explanation of the study and provided written informed consent
Individuals who meet one of the following:
(1) Long-term practitioners of Japanese poetry recitation (>=10 years of practice)
(2) Physically active individuals based on IPAQ criteria
(3) Inactive individuals with no regular exercise habits
Individuals who can safely undergo the physiological measurements (AVI, API, blood pressure, salivary amylase, PEF)
Key exclusion criteria
1. History of major cardiovascular disease or cerebrovascular disease
2. Severe respiratory disorders or acute respiratory exacerbations
3. Any condition judged inappropriate for participation by the investigators
Target sample size
104
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Kobayashi |
Organization
Teikyo University of Science
Division name
Aculty of Life and Environmental Sciences, enter for General Education
Zip code
120-0045
Address
2-2-1 Senju-Sakuragi, Adachi-ku, Tokyo
TEL
03-6910-1010
rkobayashi@ntu.ac.jp
Public contact
Name of contact person
| 1st name | Kazushige |
| Middle name | |
| Last name | Iguchi |
Organization
Teikyo University of Science
Division name
General Affairs Division, Section 1 - Research Support, Grants, and Community Collaboration
Zip code
120-0045
Address
2-2-1 Senju-Sakuragi, Adachi-ku, Tokyo
TEL
03-6910-3520
Homepage URL
kenkyushien@ntu.ac.jp
Sponsor or person
Institute
Teikyo University of Science
Institute
Department
Personal name
Funding Source
Organization
The Tama City Shigin Federation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Review Committee of Teikyo University of Science
Address
2-2-1 Senju-Sakuragi, Adachi-ku, Tokyo
Tel
03-6910-3520
kenkyushien@ntu.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
| 2025 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
104
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
Completed
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a cross-sectional observational study designed to compare arterial stiffness indices (AVI and API), respiratory function (PEF), blood pressure, and salivary alpha-amylase among three groups of community-dwelling middle-aged and older adults: poetry recitation practitioners, inactive individuals, and physically active individuals. No intervention was implemented; all measurements were conducted under participants' usual lifestyle conditions.
Participants were recruited through local public announcements, and written informed consent was obtained before study participation. Group allocation was based on physical activity levels assessed using the IPAQ and long-term poetry recitation practice (>=10 years of continuous registration and practice). All measurements were performed during a single visit, using the PASESA AVE-2000 device for AVI/API, a salivary amylase monitor, and a peak flow meter.
The study was approved by the Ethics Review Committee of Teikyo University of Science (Approval No. 24A071) and was conducted as a non-randomized observational study without any intervention.
Management information
Registered date
| 2025 | Year | 11 | Month | 24 | Day |
Last modified on
| 2025 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068458
