Tokyo, Aug. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058664) titled 'Comparative Effects of Exercise Combined with Nutrition versus Sleep Interventions on Locomotive Syndrome in Older Adults' on Aug. 3.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Hiroshima University
Condition:
Condition - Older adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to compare the effects of an exercise plus nutrition intervention and an exercise plus sleep management intervention on locomotive function in older adults, and to explore the effectiveness of each approach.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Multi-component exercises and consumption of a variety of foods, including protein foods, during 12 weeks
Interventions/Control_2 - Multi-component exercises and performing sleep-promoting behaviors, during 12 weeks
Eligibility:
Age-lower limit - 65
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Individuals aged 65 years or older at the time of consent, and those who can provide written informed consent for participation in this study
Key exclusion criteria - Individuals who already have a habit of strength training, specifically those who have performed lower limb strength training three or more times per week in the past year.
Individuals who have previously participated in a similar study.
Individuals who are unable to stand up promptly from a chair due to low back pain or knee pain.
Individuals who have difficulty consuming the protein product provided in this study (Savas Milk Protein).
Individuals who are currently consuming "health supplements" (including foods with health claims), or plan to consume them during the study period.
Individuals whom a physician has advised to refrain from physical exercise.
Individuals currently undergoing treatment for sleep disorders, such as insomnia, or those who are self-medicating with over-the-counter sleep aids.
Individuals are currently receiving treatment for mental disorders such as depression.
Individuals who possess a physical disability certificate or a mental disability certificate.
Individuals who habitually monitor their physical activity or sleep duration using a wristband-type activity tracker.
Any other individuals deemed inappropriate for participation by the principal investigator or co-investigators.
Target Size - 48
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 06 Month 27 Day
Date of IRB - 2025 Year 07 Month 12 Day
Anticipated trial start date - 2025 Year 07 Month 31 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066532
Disclaimer: Curated by HT Syndication.