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

Not Applicable

• Conditions: Mild Cognitive Impairment; Fall
• Interventions: Behavioral: Exercise; Behavioral: Computerized training

• Registration Number: NCT03839576
• Lead Sponsor: Taipei Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-15
• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Status Verified: 2022-01
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-10-03
• Primary Completion: 2023-01-24
• Study Completion: 2023-01-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 252

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lower extremity strengthening	Exercise	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.
Computerized cognitive training	Computerized 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.
Tai chi chuan	Exercise	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.

Primary Outcome Measures

Name	Time	Method
Mattis Dementia Rating Scale (MDRS)	12 months	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.
balance	12 months	The Tinetti balance score ranges 0\~26, with a higher score indicating a better balance ability.
falls	12 months	number of falls and multiple falls
mobility	12 months	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.
modified Telephone Interview of Cognitive Status (TICS-M)	12 months	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.

Secondary Outcome Measures

Name	Time	Method
fear of falling	12 months	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.
depressive symptoms	12 months	Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale.
activity of daily living (ADL)	12 months	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.

Trial Locations

Locations (1)

Taipei Medical University; 🇨🇳 Taipei, Taiwan