Motor Signature, Falls Risk, and Home-Based Interventions in Older Adults With Mild Cognitive Impairment

A single-blinded, randomized controlled trial is designed to compare the effects of social interaction, computerized cognitive training, lower extremity strengthening, and tai chi chuan on improving cognitive functions and gait/mobility and reducing falls among 228 subjects with mild cognitive impairment, in which the influence of adherence to the intervention programs will also be examined.

Study Overview

• Status: Recruiting
• Conditions: Fall; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Computerized training

• Study Type: Interventional
• Enrollment (Anticipated): 252
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mau-Roung Lin, Professor; Phone Number: 6572 886-2-27361661; Email: mrlin@tmu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Recruiting
    • Taipei Medical University
    • Contact: Chih-Yi Chen, Master; Phone Number: 6572 886-2-27361661; Email: m513090003@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 65 years old
• Had a fall at least 3 months prior to the baseline assessment
• Can ambulate independently
• Has mild cognitive impairment

Exclusion Criteria:

• Cannot ambulate independently and communicate with researchers
• Have a major unstable cardiopulmonary disease (e.g., ischemic chest pain, shortness of breath, recurrent syncopal episodes, orthopnea, paroxysmal nocturnal dyspnea, palpitations, or tachycardia)
• Have a contraindication to physical exercise (e.g., severe osteoarthritis or severe pulmonary hypertension)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computerized cognitive training; The computerized cognitive training will take place at each participant's residence. Participants will be asked to practice at least 1 session a day for 6 months, and a session lasts for 60 minutes.	Behavioral: Computerized training; Attention, memory, speed of processing, and executive functioning.
Experimental: Lower extremity strengthening; This exercise will comprise stretching, muscle strengthening, and balance training at increasing difficulty levels, tailored and supervised by a physical therapist, and will take place at a subject's residence or in the neighborhood once a week for 6 months. Each session will last 60 min.	Behavioral: Exercise; Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.
Experimental: Tai chi chuan; The 8-form Yang-style tai chi intervention will take place at a subject's residence or the neighborhood once a week for 6 months, and each session will last for 60 minutes.	Behavioral: Exercise; Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.
No Intervention: Social interaction; Immediately after the baseline assessment, the care manager will visit the subject in this group once for comparability with the other two intervention groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mattis Dementia Rating Scale (MDRS)	The Mattis Dementia Rating Scale (MDRS) contains five cognitive domains of attention, initiation/perseveration, construction, conceptualization, and memory, which specifically assess concentration, verbal fluency, visuospatial skills, analogical reasoning, and short-term memory, with score ranges for these domains of 0~37, 0~37, 0~6, 0~39, and 0~25 points, respectively, and a total score range of 0~144 points.	12 months
modified Telephone Interview of Cognitive Status (TICS-M)	The modified Telephone Interview of Cognitive Status (TICS-M) consists of the date of the interview, age, phone number, immediate and delayed word list recall, counting backward, responsive naming, word opposites, and repetition, with a total score range of 0~50.	12 months
mobility	The timed up and go test requires subjects to rise from a standard chair, walk a distance of 3 m, turn, walk back to the chair, and sit down. The time to complete the timed up and go will be recorded.	12 months
balance	The Tinetti balance score ranges 0~26, with a higher score indicating a better balance ability.	12 months
falls	number of falls and multiple falls	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
depressive symptoms	Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale.	12 months
fear of falling	Activities-specific Balance Confidence (ABC) scale assesses an individual's confidence in performing 16 common daily tasks without losing balance, and total scores of the ABC scale are determined by the accumulated average of each item score and range between 0 and 100, with lower scores indicating greater balance confidence.	12 months
activity of daily living (ADL)	The activity of daily living (ADL) scale consists of seven basic ADLs (self-feeding, self-dressing, grooming, walking, getting in/out of bed, bathing, and controlling the bladder) and seven instrumental ADLs (using a telephone, transporting oneself, shopping, preparing meals, doing housework, taking medication, and managing one's money). These items are graded as 0 points (inability), 1 point (needs some help), or 2 points (no help needed). The ADL score ranges from 0 to 28 points, with a lower score indicating greater activity disability.	12 months

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Principal Investigator: Mau-Roung Lin, Professor, Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Anticipated): January 24, 2023
• Study Completion (Anticipated): January 24, 2023

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: gait; falls; mobility; mild cognitive impairment; physical exercise; computerized cognitive training; tai chi chuan
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: MOST106-2314-B-038-046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No