Tokyo, Oct. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059399) titled 'Effects of a Sleep Education Program on Physical Frailty in Community-Dwelling Older Adults: A Randomized Controlled Trial' on Oct. 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - Kyushu University
Condition:
Condition - Physical frailty/Physical pre-frailty
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Intervention group: Sleep education program (once a week for 6 weeks)
Interventions/Control_2 - Control group: Usual daily life (6 weeks)
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 Size - 62
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067322
Disclaimer: Curated by HT Syndication.
