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

Primary Purpose

Mild Cognitive Impairment, Fall

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Exercise
Computerized training
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring gait, computerized cognitive training, falls, mild cognitive impairment, mobility, physical exercise, tai chi chuan

Eligibility Criteria

65 Years - 100 Years (Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Taipei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Computerized cognitive training

Lower extremity strengthening

Tai chi chuan

Social interaction

Arm Description

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.

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.

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.

Immediately after the baseline assessment, the care manager will visit the subject in this group once for comparability with the other two intervention groups.

Outcomes

Primary Outcome Measures

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.
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.
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.
balance
The Tinetti balance score ranges 0~26, with a higher score indicating a better balance ability.
falls
number of falls and multiple falls

Secondary Outcome Measures

depressive symptoms
Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale.
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.
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.

Full Information

First Posted
January 31, 2019
Last Updated
September 28, 2022
Sponsor
Taipei Medical University
Collaborators
Ministry of Science and Technology, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03839576
Brief Title
Motor Signature, Falls Risk, and Home-Based Interventions in Older Adults With Mild Cognitive Impairment
Official Title
Motor Signature, Falls Risk, and Home-Based Interventions in Older Adults With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
January 24, 2023 (Anticipated)
Study Completion Date
January 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University
Collaborators
Ministry of Science and Technology, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Fall
Keywords
gait, computerized cognitive training, falls, mild cognitive impairment, mobility, physical exercise, tai chi chuan

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
252 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Computerized cognitive training
Arm Type
Experimental
Arm Description
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.
Arm Title
Lower extremity strengthening
Arm Type
Experimental
Arm Description
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.
Arm Title
Tai chi chuan
Arm Type
Experimental
Arm Description
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.
Arm Title
Social interaction
Arm Type
No Intervention
Arm Description
Immediately after the baseline assessment, the care manager will visit the subject in this group once for comparability with the other two intervention groups.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.
Intervention Type
Behavioral
Intervention Name(s)
Computerized training
Intervention Description
Attention, memory, speed of processing, and executive functioning.
Primary Outcome Measure Information:
Title
Mattis Dementia Rating Scale (MDRS)
Description
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.
Time Frame
12 months
Title
modified Telephone Interview of Cognitive Status (TICS-M)
Description
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.
Time Frame
12 months
Title
mobility
Description
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.
Time Frame
12 months
Title
balance
Description
The Tinetti balance score ranges 0~26, with a higher score indicating a better balance ability.
Time Frame
12 months
Title
falls
Description
number of falls and multiple falls
Time Frame
12 months
Secondary Outcome Measure Information:
Title
depressive symptoms
Description
Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale.
Time Frame
12 months
Title
fear of falling
Description
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.
Time Frame
12 months
Title
activity of daily living (ADL)
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mau-Roung Lin, Professor
Phone
886-2-27361661
Ext
6572
Email
mrlin@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mau-Roung Lin, Professor
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chih-Yi Chen, Master
Phone
886-2-27361661
Ext
6572
Email
m513090003@tmu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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

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