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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fallers, Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A pragmatic, single-blinded, randomized controlled trial with three arms will be conducted to investigate the effectiveness of conventional exercise and tai chi chuan, compared to health education/usual physical activity.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional exercise<br>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<br>* Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.<br>|
| Experimental: Tai chi chuan<br>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<br>* Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.<br>|
| No Intervention: Health education/usual physical activity<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarker, Cognitive impairment, Gait abnormality, Older Adults, Exercise