Restoring Central Motor Control Extension

Study Overview
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Brief Summary
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Motor skill training therapy aims to improve the brain's control of walking and can improve clinic-based measures of walking in older adults. However, it is unknown whether the benefits of motor skill training extend to real world mobility measures. The investigators will test the effects of motor skill training on measures of community mobility of older adults and assess the mechanisms through improved motor control at the level of the brain. These results will inform intervention approaches to maintain community mobility of older adults and prevent disability and institutionalization.

Official Title
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Restoring Central Motor Control to Improve Community Mobility of Older Adults

Conditions
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Gait, Unsteady

Intervention / Treatment
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* Behavioral: Strength training
* Behavioral: Endurance training
* Behavioral: Flexibility training
* Behavioral: Physical activity behavioral intervention
* Behavioral: Task Specific timing and coordination training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 65 years of age and older Ambulatory without an assistive device or the assistance of another person Usual 4 meter gait speed > 0.60 m/s and < 1.2 m/s Physician clearance to participate in a moderate intensity exercise program Not meeting physical activity recommendations defined as reporting less than 150 minutes of moderate intensity activity per week in the past month. Exclusion Criteria: persistent lower extremity pain that is present on most days of the week back pain that is present on most days of the weeks and interferes with walking and - activities of daily living or back pain that increases with walking refuse to walk on a treadmill plans to move out of the area in the next 5 years dyspnea at rest or during activities of daily living or use supplemental oxygen (CHF, COPD) any acute illness or medical condition that is not stable according to the approving physician resting systolic blood pressure ≥ 200 mm Hg or diastolic blood pressure ≥ 100 mm Hg or resting heart rate > 100 or < 40 beats per minute diagnosed dementia or cognitive impairment defined as modified Mini-Mental State (3MS) examination <79 hospitalized in the past 6 months for acute illness or surgery, other than minor surgical procedures severe visual impairment f- ixed or fused lower extremity joints such as hip, knee or ankle lower extremity strength <3/5 on manual muscle testing lower extremity amputation progressive movement disorder such as Multiple Sclerosis, Amyotrophic Lateral Sclerosis or Parkinson's disease

Ages Eligible for Study
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Minimum Age: 65 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>The standard arm consists of strength, endurance and flexibility exercises 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention. | Behavioral: Strength training<br>* weight lifting to increase muscle strength<br>Behavioral: Endurance training<br>* treadmill walking to increase endurance<br>Behavioral: Flexibility training<br>* stretches to improve flexibility<br>Behavioral: Physical activity behavioral intervention<br>* Intervention to encourage participants to be more physically active<br>|
| Experimental: Standard-plus<br>The standard-plus arm consists of strength, endurance and flexibility exercises plus task specific timing and coordination exercises to improve gait 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention. | Behavioral: Strength training<br>* weight lifting to increase muscle strength<br>Behavioral: Endurance training<br>* treadmill walking to increase endurance<br>Behavioral: Flexibility training<br>* stretches to improve flexibility<br>Behavioral: Physical activity behavioral intervention<br>* Intervention to encourage participants to be more physically active<br>Behavioral: Task Specific timing and coordination training<br>* stepping and walking patterns to improve timing and coordination of gait<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking | Physiologic measure indicative of usage of the prefrontal cortex during a task recorded by optical imaging (near infrared spectroscopy). | change from baseline to 12 weeks | 
| Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking | Physiologic measure indicative of usage of the prefrontal cortex during a task recorded by optical imaging (near infrared spectroscopy). | change from baseline to 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait speed | Walking speed (m/s) during usual pace | 12, 24, and 36 weeks | 
| Gait speed | Walking speed (m/s) with a cognitive challenge. | 12, 24, and 36 weeks | 
| Gait speed | Walking speed (m/s) on an uneven surface. | 12, 24, and 36 weeks | 
| Gait variability | Fluctuations in gait characteristics from step to step during usual pace. Physiologic measure of temporal gait characteristics (standard deviation). | 12, 24, and 36 weeks | 
| Gait variability | Fluctuations in gait characteristics from step to step while walking with a cognitive challenge. Physiologic measure of temporal gait characteristics (standard deviation). | 12, 24, and 36 weeks | 
| Gait variability | Fluctuations in gait characteristics from step to step while walking on an uneven surface. Physiologic measure of temporal gait characteristics (standard deviation). | 12, 24, and 36 weeks |