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

Study Overview
=================
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.

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

Conditions
-----------------
Mild Cognitive Impairment, Fall

Intervention / Treatment
-----------------
* Behavioral: Exercise
* Behavioral: Computerized training


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computerized cognitive training<br>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<br>* Attention, memory, speed of processing, and executive functioning.<br>|
| Experimental: Lower extremity strengthening<br>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<br>* Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.<br>|
| Experimental: Tai chi chuan<br>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<br>* Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.<br>|
| No Intervention: Social interaction<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gait, computerized cognitive training, falls, mild cognitive impairment, mobility, physical exercise, tai chi chuan