Locomotor Adaptation Training to Prevent Mobility Disability
NCT ID: NCT02554916
Last Updated: 2019-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
58 participants
OBSERVATIONAL
2010-07-31
2019-07-17
Brief Summary
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Detailed Description
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Prior to and following 16 weeks of therapy, we will observe the participants' performing several functional movements (walking, standing from sitting, sitting from standing, walking up and down stairs) and measure their muscular activity. These performance-based measures will be obtained to determine whether their movement function improves as a result of therapeutic intervention. The participants' absolute performance on any of these tasks does not matter as much as that they make the very best effort on each of the tests. They are welcome to take a break at any point in the testing or training.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Dual-belt Exercise
The participants assigned to this group will use the dual-belt treadmill 3 times a week for 16 weeks.
Dual-Belt Exercise
The dual-belted exercise treadmill can control the speeds of the right and left legs individually. When asymmetric, the dual-belt treadmill imposes mechanical and sensory perturbations independently to each leg such that the central nervous system (CNS) must solve and adapt to the challenge to maintain walking.
Dual-Belt Treadmill
Treadmill Exercise
The participants assigned to this group will use the treadmill 3 times a week for 16 weeks.
Treadmill Exercise
The treadmill exercise will maintain the speed of the right and left leg together while walking.
Dual-Belt Treadmill
Usual Care
The participants assigned to this group will not use the treadmills.
Usual Care
This group will not be assigned to a treadmill but is as a non-exercising control group.
Interventions
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Dual-Belt Exercise
The dual-belted exercise treadmill can control the speeds of the right and left legs individually. When asymmetric, the dual-belt treadmill imposes mechanical and sensory perturbations independently to each leg such that the central nervous system (CNS) must solve and adapt to the challenge to maintain walking.
Treadmill Exercise
The treadmill exercise will maintain the speed of the right and left leg together while walking.
Usual Care
This group will not be assigned to a treadmill but is as a non-exercising control group.
Dual-Belt Treadmill
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gait Speed of ≤ 1m/s
* Summary score 7-10 on the Short Physical Performance Battery, indicating mild to moderate impairment
* Sedentary as defined by reporting \<20 min/wk of performing regular physical activity in the past month and \<125 min/wk of moderate physical activity on the CHAMPS-18 questionnaire
* Willingness to be randomized to any of the treatment groups
Exclusion Criteria
* Planned surgery in next year
* Hospitalization within the past 6 months
* Smoker \> 1 pack per day
* Significant cognitive impairment, defined as a known diagnosis of dementia or a Modified Mini-Mental State score \<24
* Significant cognitive executive impairment, defined as a Montreal Cognitive Assessment (MoCA) score of\<25
* Progressive, degenerative neurologic disease, e.g., Parkinson's Disease, multiple sclerosis, Amyotrophic lateral sclerosis (ALS)
* Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, active inflammatory disease
* Terminal illness with life expectancy less than 12 mos, as determined by a physician
* Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen
* Severe cardiac disease, including New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina;
* Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention, e.g. renal failure on hemodialysis, severe psychiatric disorder (e.g. bipolar, schizophrenia), excessive alcohol use (\>14 drinks per wk); persons with depression will not be excluded
* Develops chest pain or severe shortness of breath during exercise test
* Unable to communicate because of severe hearing loss or speech disorder or language barrier
* Lives outside of the study site or is planning to move out of the area in next year or leave the area for \>1 month during the next year
* Severe diabetes, requiring use of insulin
65 Years
ALL
Yes
Sponsors
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University of Florida
OTHER
National Institute on Aging (NIA)
NIH
Responsible Party
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Principal Investigators
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Chris J Hass, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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Other Identifiers
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IRB201400915-N
Identifier Type: -
Identifier Source: org_study_id
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