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Clinical Trial Summary

The objective of this study is to investigate psychometric properties of dual-task walking assessments and compare effects of combined motor and cognitive training on physical fitness, brain fitness, and dual-task walking performance in pre-frail elderly. Specifically, we will investigate psychometric properties (i.e. reliability and validity) of dual-task walking assessments for pre-frail elderly (Aim 1). The second aim of this study is to compare the effects of combined motor and cognitive training vs. motor training alone vs. cognitive training alone vs. no intervention control on physical fitness, brain fitness, and dual-task walking performance in pre-frail elderly (Aim 2). The third aim of this study is to elucidate the effects of combined motor and cognitive training on patterns of cognitive motor interference in pre-frail elderly (Aim 3).


Clinical Trial Description

A metric analysis and comparative efficacy research will be conducted. Eighty-four pre-frail elderly will receive dual-task walking assessments twice at pretreatment with a 1-week interval for test-retest assessment and investigation of the reliability and validity of outcome measures. The primary outcome measure of the dual-task walking assessments will include walking at preferred speed and fast speed and simultaneously perform serial three subtractions and the Stroop task. Concurrent validity will be studied to validate the dual-task walking measures with each other and with the item 14 of the mini-Balance Evaluation Systems test (Mini-BESTest), dual-task Timed-up-and-Go test (dual-TUG), and 6-min walk test obtain concurrently for assessing dual-task ability. A comparative efficacy research is a single-blind, randomized controlled trial, which will be conducted at medical centers. Pre-frail elderly will be randomized to combined motor and cognitive training, motor training alone, cognitive training alone, or no intervention control group. All three training groups will receive interventions 3 times a week for 4 weeks. The combined motor and cognitive training group will undertake physical fitness training under sitting and standing, walking training while sequentially or simultaneously perform cognitive training. The motor training alone group will train the same set of physical fitness training while sitting, standing, and walking as the combined motor and cognitive training group. The cognitive training alone group will train the same set of cognitive training while sitting as the combined motor and cognitive training group. No intervention control group will maintain habit and daily activity. A blinded assessor will administer three assessments. All participants will be examined physical fitness and brain fitness at baseline twice, and post intervention. The primary outcome measures will be components of physical fitness (cardiopulmonary fitness, muscle fitness, flexibility, body composition, and balance)and brain fitness (information processing speed, working memory, response inhibition, spatial memory, and selective attention). The secondary outcome measures will be gait and cognitive performance under dual-task conditions, dual-Timed Up and Go test, the Mini-BESTest, Functional Gait Assessment, and 6-minute Walk Test, Repeated measure ANOVA will be used to compare measurements at baseline and after training among the groups. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04605809
Study type Interventional
Source Chang Gung University
Contact Li-Ling Chuang, Ph.D.
Phone 886-3-2118800
Email lchuang@gap.cgu.edu.tw
Status Recruiting
Phase N/A
Start date March 8, 2021
Completion date July 31, 2024

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