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

Sponsor

Taipei Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03839576

Collaborator

National Science Council, Taiwan (Other)

228

Enrollment

Location

Arms

29.5

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment Fall	Behavioral: Exercise Behavioral: Computerized training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

228 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 15, 2019

Anticipated Primary Completion Date :

Jul 31, 2021

Anticipated Study Completion Date :

Jul 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

cognitive functions [12 months]
Minimal Mental State Examination
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.
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

Secondary Outcome Measures

depressive symptoms [12 months]
Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale.
fear of falling [12 months]
Fear of falling will be assessed using the Falls Efficacy Scale (FES) test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)