Tokyo, April 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059960) titled 'Agility Training to Reduce Falls and Improve Intrinsic Capacity in Older Adults with Mild Cognitive Impairment' on April 5.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Iran National Science Foundation
Condition:
Condition - Pre-frailty and Mild Cognitive Impairment (MCI) in Community Dwelling Older Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of an eight-week agility-based fall-prevention training program on motor function, cognitive function, mental health, and vitality in community-dwelling pre-frail older adults with mild cognitive impairment.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants will complete an eight-week supervised agility-based fall-prevention program with three 30-45 minute sessions per week. Each session includes a warm-up, a circuit of exercises targeting balance, agility, motor function, and dual-task performance (for example, cone weaving, tandem walking, stair navigation, figure-8 walking, side-stepping, shuttle walks, and ball toss), and a cool-down. Exercises progressively increase in intensity and complexity and are tailored to individual abilities. All sessions are supervised by trained professionals, and a brief pilot phase ensures safety and feasibility before the main trial.
Interventions/Control_2 - Control participants will receive no intervention during the eight-week study period and will continue their usual daily activities. To ensure equipoise and ethical compensation for participation, the control group will be offered four supervised training sessions using the same protocol after study completion.
Eligibility:
Age-lower limit - 65
years-old
=
Gender - Male and Female
Key inclusion criteria - Age 65 years or older, Barthel Index 60 or higher, able to communicate and walk independently, diagnosed with mild cognitive impairment or mild dementia (DSM-5), Global Deterioration Scale 3 or higher, frailty score 2 or higher (Fried), and availability of a caregiver to assist with exercises.
Key exclusion criteria - Medical contraindications to exercise (PAR-Q), severe cardiovascular, musculoskeletal, respiratory, or cerebrovascular diseases, neurodegenerative or psychiatric disorders, vestibular disorders, uncontrolled hypertension (>160/100 mmHg), or severe uncorrected visual impairment/retinal detachment.
Target Size - 68
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 05 Day
Anticipated trial start date - 2025 Year 12 Month 10 Day
Last follow-up date - 2026 Year 06 Month 04 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068543
Disclaimer: Curated by HT Syndication.