UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056004 |
|---|---|
| Receipt number | R000064004 |
| Scientific Title | Establishment of health indicators based on lifestyle and measurements of respiratory and circulatory function in healthy young people |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2025/11/04 11:35:41 |
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Basic information
Public title
Establishment of health indicators based on lifestyle and measurements of respiratory and circulatory function in healthy young people
Acronym
Respiratory and circulatory function and lifestyle in healthy young adults
Scientific Title
Establishment of health indicators based on lifestyle and measurements of respiratory and circulatory function in healthy young people
Scientific Title:Acronym
Respiratory and circulatory function and lifestyle in healthy young adults
Region
| Japan |
Condition
Condition
healthy young person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study focuses on topics related to the rehabilitation of respiratory and circulatory functions, with the aim of improving the health of healthy individuals and the effectiveness of patient rehabilitation. The goal is to improve physical function and health through a full survey of healthy young Japanese men and women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluate changes in respiratory function due to the subject's sleep posture.
Measure lung capacity, % lung capacity, effort lung capacity, volume per second, rate per second, minute ventilation, blood pressure, pulse rate, SpO2, respiratory rate, thoracic range of motion, height, and weight.
Key secondary outcomes
Examine relevant factors that influence the subject's vital signs and circulatory function.
Blood pressure, pulse rate, SpO2, respiratory rate, thoracic range of motion, height, weight, BMI, body composition, body water content, limb skeletal muscle mass, PhA, and body fat mass will be measured.
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
| 19 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects for whom written consent to participate in research of their own free will can be obtained from the individual.
Key exclusion criteria
Those who withdrew their consent to participate in the study (no exclusions due to disease or other reasons).
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | minami |
| Middle name | |
| Last name | sato |
Organization
International University of Health and Welfare, Odawara College of Health Sciences
Division name
Department of Physical Therapy
Zip code
250-8588
Address
Shiroyama 1-2-25, Odawara-shi, Kanagawa
TEL
0465-21-6724
msato@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | minami |
| Middle name | |
| Last name | sato |
Organization
International University of Health and Welfare, Odawara College of Health Sciences
Division name
Department of Physical Therapy
Zip code
250-8588
Address
Shiroyama 1-2-25, Odawara-shi, Kanagawa
TEL
0465-21-6724
Homepage URL
msato@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare, Odawara College of Health Sciences
Institute
Department
Personal name
Minami Sato
Funding Source
Organization
no
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
International University of Health and Welfare, Odawara College of Health Sciences
Address
Shiroyama 1-2-25, Odawara-shi, Kanagawa
Tel
0465-21-6724
msato@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
| 2024 | Year | 11 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the effects of different sleep positions and exercise on respiratory function with the aim of improving or maintaining respiratory function. In particular, through research with healthy young men and women, we will seek effective treatment and rehabilitation methods for patients with chronic respiratory diseases and pulmonary dysfunction.
To study the recovery process after appropriate exercise load to improve or maintain circulatory function, and to evaluate methods (music, scents, exercise load adjustments, etc.) that promote recovery. In addition, the relationship between work efficiency and vital signs will be clarified. In particular, we will monitor vital signs such as blood pressure, heart rate, heart rate variability, and oxygen saturation in detail to find effective interventions for recovery of cardiac function.
Management information
Registered date
| 2024 | Year | 10 | Month | 31 | Day |
Last modified on
| 2025 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064004
