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

NCT03839576 | Unknown

• 1 other identifier: MOST106-2314-B-038-046
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Fall

Keywords

gait; computerized cognitive training; falls; mild cognitive impairment; mobility; physical exercise; tai chi chuan

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• depressive symptoms

  12 months

• fear of falling

  12 months

• activity of daily living (ADL)

  12 months

Study Arms (4)

Computerized cognitive training

EXPERIMENTAL

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

Lower extremity strengthening

EXPERIMENTAL

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

Tai chi chuan

EXPERIMENTAL

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

Social interaction

NO INTERVENTION

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

Interventions

Exercise BEHAVIORAL

Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.

Lower extremity strengthening; Tai chi chuan

Computerized training BEHAVIORAL

Attention, memory, speed of processing, and executive functioning.

Computerized cognitive training

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• At least 65 years old
• Had a fall at least 3 months prior to the baseline assessment
• Can ambulate independently
• Has mild cognitive impairment

You may not qualify if:

• 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)

Sponsors & Collaborators

• Taipei Medical University: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mau-Roung Lin, Professor

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mau-Roung Lin, Professor

CONTACT

886-2-27361661; mrlin@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 15, 2019
• Study Start: February 15, 2017
• Primary Completion: January 24, 2023
• Study Completion: January 24, 2023
• Last Updated: October 3, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)