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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03839576
• Other study ID #: MOST106-2314-B-038-046
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2017
• Est. completion date: January 24, 2023

Study information

• Verified date: January 2022
• Source: Taipei Medical University
• Contact: Mau-Roung Lin, Professor
• Phone: 886-2-27361661
• Email: mrlin[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: January 24, 2023
• Est. primary completion date: January 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Fall
• Mild Cognitive Impairment

Intervention

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.
• Computerized training
Attention, memory, speed of processing, and executive functioning.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	balance	The Tinetti balance score ranges 0~26, with a higher score indicating a better balance ability.	12 months
Primary	falls	number of falls and multiple falls	12 months
Secondary	depressive symptoms	Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale.	12 months
Secondary	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
Secondary	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