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临床试验/CTRI/2026/02/103992
CTRI/2026/02/103992招募中不适用

Effects of cognitive motor dual task and multimodal exercises on fall risk, intrinsic capacity and quality of life in older adults with cognitive frailty a randomized controlled trial

Rejimol Jos Pulicken1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2026年2月27日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
126
试验地点
1

研究概览

简要总结

Title of the Study Effects of Cognitive Motor Dual Task and Multimodal Exercise on Fall Risk Intrinsic Capacity and Quality of Life in Older Adults with Cognitive Frailty A Randomized Controlled Trial

Background Population aging in India is increasing the prevalence of functional limitations. Cognitive Frailty is a high risk geriatric syndrome characterized by the coexistence of physical frailty and cognitive impairment excluding dementia. It is a significant predictor of future falls. Intrinsic Capacity is an integrative measure of physiologic reserve across locomotion vitality cognition psychological and sensory domains. Evidence suggests that cognitive motor dual task training and multimodal exercises may improve functional capacity and reduce fall risk in this population.

Objectives The primary objective is to compare the effects of cognitive motor dual task training multimodal exercise and standard care on fall risk. Secondary objectives include comparing post intervention effects on the Intrinsic capacity composite score and overall quality of life among the three groups.

Methodology This is a three arm parallel group assessor blinded randomized controlled trial conducted in selected elderly homes in central Kerala. Participants aged 65 and above with cognitive frailty will be recruited and randomized into three groups using block randomization. The sample size is 126 participants with 42 per group. The intervention groups will receive either dual task training or multimodal exercises for twelve weeks three days per week for 50 minutes per session. Standard care includes health education.

Cognitive Motor Dual Task program focuses on performing cognitive tasks while simultaneously or sequentially performing motor training. Individualized 20-minute sessions focus on dual-task progression, while 30-minute group sessions involve functional circuits, resistance training, or dance. Cognitive stimuli include tasks involving speech, memory, arithmetic thinking, and attention. Complexity increases from sequential to simultaneous tasks based on participant achievement.

Multimodal Exercise Participants receive a supervised 12-week intervention comprising resistance, balance, cardiovascular, and flexibility exercises 3 times per week. Each 45 to 50-minute session includes individual and group-based training. Resistance training involves 3 sets of 12 repetitions using weights or resistance bands, while cardiovascular training consists of walking bouts. Balance training includes static and dynamic exercises such as walking on heels or toes. Flexibility training involves arm stretches held for 12 seconds. Intensity is tailored to each participant Rate of Perceived Exertion using the Borg Scale

Control Group receives health education on aging, nutrition, and social engagement and is advised to continue only their usual activity levels.

Primary outcome measures is Timed Up and Go for fall risk. Secondary outcomes intrinsic capacity will be calculated based on domain scores of Short Physical Performance Battery for locomotion hand grip for vitality MoCA for cognition GDS for depression. Quality of life is assessed using SF 12.

Expected Outcome Post intervention measures are taken at the end of 12 weeks. It is hypothesized that there will be a significant difference in post intervention effects between the three groups specifically that targeted exercise interventions will reduce fall risk and optimize intrinsic capacity and quality of life in cognitively frail older adults.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
65.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Participants with physical frailty, mild cognitive impairment and functional independence.

排除标准

  • Participants with dementia, severe cognitive impairment, severe depression, degenerative diseases of nervous system , vision and hearing impairment.

研究者

发起方
Rejimol Jos Pulicken
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Rejimol Jos Pulicken

LIttle Flower Institute Of Medical Sciences And Research ,Angamaly

研究点 (1)

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