Temporal Relations and Exercise Interventions of Various Gait and Cognitive Domains in Older Adults

The effectiveness of conventional exercise, tai chi chuan and health education/usual physical activity over a 6-month intervention period in improving primary outcomes and secondary outcomes in older mild cognitive impairment adults will be compared. Third, whether changes in serum levels of the brain-derived neurotrophic factor (BDNF), insulin-like growth factor (IGF)-1, and vascular endothelial growth factor (VEGF) and expression of the apolipoprotein E (APOE) ε4 allele parallel changes in gait characteristics and cognitive functions after the intervention will be examined.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment; Fallers
• Intervention / Treatment: Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Anticipated): 189
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mau-Roung Lin, Professor; Phone Number: 6572 886-2-27361661; Email: mrlin@tmu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Recruiting
    • Taipei Medical University
    • Contact: Chih-Yi Chen, Master; Phone Number: 6572 886-2-27361661; Email: m513090003@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 65 years old
• Had an emergency department visit due to a fall at least 3 months prior to the baseline assessment (assuming a full recovery time from a fall to be 3 months)
• Can ambulate independently
• Has mild cognitive impairment

Exclusion Criteria:

• Do not live in a community setting
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional exercise; 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 chuan intervention will take place at a subject's residence or in the neighborhood once a week for 6 months, and 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.
No Intervention: Health education/usual physical activity; After the baseline, the case manager will visit subjects in this group once for comparability with the other two intervention groups and instruct them to maintain their usual physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait characteristics	Performance on six gait characteristics (velocity, cadence, stride length, swing time, stride length variability, and swing time variability) will be measured with a 6-m electronic walkway of GAITRite.	12 months
Global cognition	Global cognition will be assessed using the Mini-Mental State Examination (MMSE). The MMSE comprises 11 questions, and the score ranges 0~30, with lower scores indicating poorer global cognition.	12 months
Serum levels of BDNF	Serum BDNF concentrations will be assessed.	12 months
Serum levels of IGF-1	Serum IGF-1 concentrations will be assessed.	12 months
Serum levels of VEGF	Serum VEGF concentrations will be assessed.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tinetti balance	The Tinetti balance score ranges 0~26, with a higher score indicating a better balance ability.	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
Muscle strength	Grip strength will be assessed via a handgrip dynamometer and measured in kilograms of isometric force.	12 months
Falls	number of falls and multiple falls	12 months
Depressive symptoms	Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale (GDS).	12 months
Fear of falling	Fear of falling will be assessed using the Falls Efficacy Scale (FES) test.	12 months

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: National Health Research Institutes, Taiwan
• Investigators: Principal Investigator: Mau-Roung Lin, Professor, Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Biomarker; Exercise; Older Adults; Cognitive impairment; Gait abnormality
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: NHRI-EX108-10804PI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No