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临床试验/CTRI/2023/12/060793
CTRI/2023/12/060793尚未招募不适用

Comparison on Effectiveness of Sequential and Simultaneous Dual-Task Training on executive functions and balance in older adults: A Randomized Controlled Trial

Jamia Millia Islamia1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
46
试验地点
1
主要终点
1. P300 records an Event-Related Potential and is used to analyze brain waveforms that corresponds to attention memory and information processing.

研究概览

简要总结

Background and Aims - Sequential Dual Task-Training is as effective as Simultaneous Dual-Task Training in improving balance and gait speed. Therefore this study aims to compare the effectiveness of sequential and simultaneous dual-training on executive training  to reverse or delay the cognitive decline associated with aging.

Methodology - It will be a prospective randomized controlled trial, including healthy older adults (60 years of age and above, both males and females, having primary level of education). The participants will be screened for mild cognitive impairment and risk of fall using Montreal Cognitive Assessment Scale (MoCA) and Short - Falls Efficacy Scale (Short- FES) respectively. 46 older adults will be randomly assigned to two groups - group 1 (SEQ-G) receiving balance exercise followed by cognitive training, group 2 (SIM-G) receiving balance exercise and cognitive training simultaneously under supervision.

Results - will be reported for all the outcome measures at baseline and post-intervention at the 8th week. Statistical analysis using SPSS software to compare the changes between the two groups and changes within the groups using 2X2 ANOVA.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • •Age > 60 years of all genders Able to walk independently without assistive device Montreal Cognitive Assessment Scale score > 21 Subjects with minimum to no risk of falls according to Short-FES (cut off score of 7-8 out of 28) Subjects upto moderate osteoarthritis (grade-3) according to Kellgren and Lawrence, 1957 Individuals with basic knowledge of primary education Able to understand simple instructions and sign an informed consent form.

排除标准

  • •Individuals with neurological and psychological disorders History of surgery in lower limb within past 6 months prior to trial Individuals with auditory or visual impairments Individuals on pharmacological treatment modifying psychological and psychiatric functions Individuals participating in any other trial.

结局指标

主要结局

1. P300 records an Event-Related Potential and is used to analyze brain waveforms that corresponds to attention memory and information processing.

时间窗: Baseline Assessment at 1st week before the commencement of trial. | At 8th week post-intervention assessment.

2. Trail Making Test (TMT-A and TMT-B) used to assess executive function and attentional abilities. Part A of TMT evaluates the information processing speed, while part B assesses cognitive flexibility or switching. In part A, the task consisted in connecting numbers (from 1 to 25) with straight lines as fast as possible. In part B, participants had to alternate between letters in alphabetical order and numbers in ascending order (1-A-2-B-3C, etc.) as fast as possible.

时间窗: Baseline Assessment at 1st week before the commencement of trial. | At 8th week post-intervention assessment.

3. The Stroop Test assesses selective attention and inhibition.

时间窗: Baseline Assessment at 1st week before the commencement of trial. | At 8th week post-intervention assessment.

次要结局

  • 1. One Leg Standing Test (OLST) evaluates static balance.

研究者

申办方类型
Other [Central University]
责任方
Principal Investigator
主要研究者

Dr Majumi M Noohu

Jamia Millia Islamia

研究点 (1)

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