UMIN-CTR Clinical Trial

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
Email	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
Email	m-sato@kochi-u.ac.jp

Sponsor
Institute	Department of Nursing, Kochi University, Graduate School of Nursing
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053270