UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059399 |
|---|---|
| Receipt number | R000067322 |
| Scientific Title | Effects of a Sleep Education Program on Physical Frailty in Community-Dwelling Older Adults: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/10/15 |
| Last modified on | 2025/10/14 17:43:54 |
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Basic information
Public title
Effects of a Sleep Education Program on Physical Frailty in Community-Dwelling Older Adults: A Randomized Controlled Trial
Acronym
Effects of a Sleep Education Program on Physical Frailty in Community-Dwelling Older Adults
Scientific Title
Effects of a Sleep Education Program on Physical Frailty in Community-Dwelling Older Adults: A Randomized Controlled Trial
Scientific Title:Acronym
Effects of a Sleep Education Program on Physical Frailty in Community-Dwelling Older Adults
Region
| Japan |
Condition
Condition
Physical frailty/Physical pre-frailty
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of a sleep education program based on cognitive-behavioral therapy on improving physical frailty in community-dwelling older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical frailty/Physical pre-frailty
Key secondary outcomes
Sleep Duration
Pittsburgh Sleep Quality Index (PSQI)
Epworth Sleepiness Scale (ESS)
Sleep Hygiene Practices Scale (SHPS)
Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
Mini-Mental State Examination (MMSE)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Sleep education program (once a week for 6 weeks)
Interventions/Control_2
Control group: Usual daily life (6 weeks)
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
1.Individuals experiencing sleep-related problems
2.Individuals classified as physical frailty or pre-frailty
3.Individuals who provided written informed consent to participate in the study
Key exclusion criteria
1.Individuals currently receiving cognitive-behavioral therapy for sleep problems
2.Individuals diagnosed by a physician with dementia or severe psychiatric disorders
3.Individuals with a certification of need for care or support
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | Hiro |
| Middle name | |
| Last name | Kishimoto |
Organization
Kyushu University
Division name
Faculty of Arts and Science
Zip code
819-0395
Address
744 Motooka, Nishi-ku, Fukuoka 819-0395, Japan
TEL
092-802-6071
kishimoto@artsci.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiro |
| Middle name | |
| Last name | Kishimoto |
Organization
Kyushu University
Division name
Faculty of Art and Science
Zip code
819-0395
Address
No.744, Motooka, Nishi-ku, Fukuoka, Japan
TEL
092-802-6071
Homepage URL
kishimoto@artsci.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kyushu University
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
Kyushu University Health Sciences and Counseling Center Joint Ethics Committee
Address
No.744, Motooka, Nishi-ku, Fukuoka, Japan
Tel
092-802-5881
kishimoto@artsci.kyushu-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 15 | 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
96
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
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 14 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067322
