UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046712 |
|---|---|
| Receipt number | R000053270 |
| Scientific Title | A Quasi-Experimental Design Focusing on Sleep and Autonomic Activity |
| Date of disclosure of the study information | 2022/02/10 |
| Last modified on | 2022/01/23 15:10:26 |
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Basic information
Public title
Development of a nursing intervention model focusing on the characteristics of sleep and autonomic activity in active older adults
Acronym
Investigating the relationship between sleep and the balance of autonomic activity in healthy elderly people
Scientific Title
A Quasi-Experimental Design Focusing on Sleep and Autonomic Activity
Scientific Title:Acronym
A Quasi-Experimental Design Focusing on Sleep and Autonomic Activity
Region
| Japan |
Condition
Condition
sleep disorder
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Characterizing Autonomic Activity in Active Elderly People Living in the Community
Basic objectives2
Others
Basic objectives -Others
Evaluate people in a good sleep state.
Assess muscle mass in two groups.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The Japanese version of the Pittsburgh Sleep Quality Index (PSQI-J)
Key secondary outcomes
JST version of Activity Capability Index
Instrumental ADL
Grip strength
Body Composition
Heart rate variability
Four questions on sarcopenia
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Seniors aged 65 and over who are active in sports, health promotion clubs, work, volunteer activities, etc.
Key exclusion criteria
People with dementia
People with severe heart disease (e.g. pacemaker)
Diabetes
People with cancer
People who are unable to answer questions about sleep and life
People with fragile skin condition
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Miki |
| Middle name | |
| Last name | Sato |
Organization
Kochi University
Division name
Nursing Science Division Clinical Nursing
Zip code
7838505
Address
Oko-Cho,nankoku Kochi, 783-8505, Japan
TEL
+81888802555
m-sato@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Sato |
Organization
Kochi University
Division name
Nursing Science Division Clinical Nursing
Zip code
7838505
Address
Oko-Cho,nankoku Kochi, 783-8505, Japan
TEL
+81888802555
Homepage URL
m-sato@kochi-u.ac.jp
Sponsor or person
Institute
Department of Nursing, Kochi University,
Graduate School of Nursing
Institute
Department
Personal name
Funding Source
Organization
JAPAN SOCIETY FOR THE PROMOTION SCIENCE KAKENHI
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kochi University
Address
Oko-Cho,nankoku Kochi, 783-8505, Japan
Tel
+81888802555
m-sato@kochi-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
高知大学医学部看護学科 （高知県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. measure muscle mass on a body composition scale
2. measure grip strength
3. electrocardiogram (to measure autonomic activity)
4. rest for 1 minute
5. arm exercise. Raise the arms in front of you, reaching your ears, and then return to the starting position. Do five sets of this movement. The researcher will be in front of you. 6.
6. rest for 1 minute.
7. ask the participants to do a double arm exercise. Ask them to raise their arms outwards to their ears and then return to the starting position. Do 5 sets of this movement in one set. The researcher in front of you will do this with you.
8. rest for 1 minute
9...End after observation.
Management information
Registered date
| 2022 | Year | 01 | Month | 24 | Day |
Last modified on
| 2022 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053270
