Locomotor Adaptation Training to Prevent Mobility Disability

Completed

• Conditions: Age-related Mobility Decline
• Interventions: Other: Usual Care; Behavioral: Dual-Belt Exercise; Behavioral: Treadmill Exercise; Device: Dual-Belt Treadmill

• Registration Number: NCT02554916
• Lead Sponsor: University of Florida

Brief Summary

This is an exploratory study designed to investigate the effects of aerobic dual belt treadmill walking versus traditional treadmill exercise on gait performance and functional capacity in older adults at risk for mobility disability. Identifying the relationship between aerobic treadmill exercise (dual belt or traditional) and the recovery of walking abilities will serve to optimize current rehabilitation approaches.

Detailed Description

Participants will be forty-eight older adults with pre-clinical mobility disability who will be randomized into one of three intervention groups: dual-belt treadmill exercise, traditional treadmill exercise, or non-contact control.

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Status Verified: 2019-07
• Primary Completion: 2019-07-17
• Study Completion: 2019-07-17
• Last Update Submitted: 2019-07-19
• Last Update Posted: 2019-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Age 65 and older
• 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

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Exclusion Criteria

• Failure to provide informed consent
• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treadmill Exercise	Dual-Belt Treadmill	The participants assigned to this group will use the treadmill 3 times a week for 16 weeks.
Usual Care	Usual Care	The participants assigned to this group will not use the treadmills.
Dual-belt Exercise	Dual-Belt Exercise	The participants assigned to this group will use the dual-belt treadmill 3 times a week for 16 weeks.
Treadmill Exercise	Treadmill Exercise	The participants assigned to this group will use the treadmill 3 times a week for 16 weeks.
Dual-belt Exercise	Dual-Belt Treadmill	The participants assigned to this group will use the dual-belt treadmill 3 times a week for 16 weeks.

Primary Outcome Measures

Name	Time	Method
Change in temporal variability	baseline and up to 6 weeks following the intervention	Temporal will be determined from kinematic and kinetic measurement methods. Lower values correspond to better walking performance.
Change in Gait Speed	baseline and up to 6 weeks following the intervention	Gait speed will be determined from kinematic and kinetic measurement methods. A low value would indicate a slower walking speed compared to a higher value (faster walking speed).
Change in spatial variability	baseline and up to 6 weeks following the intervention	Spatial will be determined from kinematic and kinetic measurement methods. Lower values correspond to better walking performance.

Secondary Outcome Measures

Name	Time	Method
Change in Disability	baseline and up to 6 weeks following the intervention	The Pepper Assessment Tool for Disability will be used. Includes 5 subscales: mobility, transferring, upper extremity, instrumental and basic activities of daily living.; Low scores indicate higher functioning and high independence. The Late-life function and Disability instrument will also be used. This has a 16-item disability component and a 32-item function component. Items are scored for 1-5 for function and 1-5 for frequency and extent of disability. Where high scores in frequency would represent more activity, and low scores in disability would represent less disabled.
Change in Timed up and Go	baseline and up to 6 weeks following the intervention	Participants will be timed in seconds. More time to complete the task indicates low function, while less time indicates high function.
Change in physical performance	baseline and up to 6 weeks following the intervention	Using the Short Physical Performance Battery. A score is generated from 0 (worst performance)-12 (best performance).
Change in cognitive impairment	baseline and up to 6 weeks following the intervention	Using the Mini Mental State Exam. Each item has 5 possible points. Scores greater than or equal to 27 (out of 30) indicates normal cognition. Severe = \<9, moderate = 10-18, and mild = 19-24 cognitive impairment.
Change in Cognitive impairment of executive function	baseline and up to 6 weeks following the intervention	Using the Montreal Cognitive assessment. 30 items. A score of less than 26 on this assessment will indicate cognitive executive function.
Change in likelihood of falling	baseline and up to 6 weeks following the intervention	Using the Dynamic Gait Index. This is an observational task that is scored on an ordinal scale. Total score per item is summed to a total score from 0(low level of function, high likelihood of falling)-24(high level of function, low likelihood of falling).
Change in knee extensor strength	baseline and up to 6 weeks following the intervention	Using an isokinetic dynamometer, we will test Knee extensor strength. Peak torque will be calculated. A high value indicates more strength. Low values indicate less strength.
Change in ankle plantarflexor strength	baseline and up to 6 weeks following the intervention	Using an isokinetic dynamometer, we will test ankle plantarflexor strength. Peak torque will be calculated. A high value indicates more strength. Low values indicate less strength.
Change in timed chair rise	baseline and up to 6 weeks following the intervention	Participants will be timed in seconds. More time to complete the task indicates low function, while less time indicates high function.
Change in timed stair climb	baseline and up to 6 weeks following the intervention	Participants will be timed in seconds. More time to complete the task indicates low function, while less time indicates high function.
Change in Ambulatory activity	baseline and up to 6 weeks following the intervention	7 day assessment using an activity monitor. The device will count the number of steps taken.
Change in energetic cost of walking	baseline and up to 6 weeks following the intervention	This will be measured by: electrocardiogram, blood pressure, spirometry tests, and ratings of perceived exertion.; The participant's maximal aerobic fitness, or oxygen consumption (VO2max) will be determined using a walking symptom-limited graded exercise test (GXT; modified walking incremental treadmill Naughton). All tests will follow the guidelines of the American College of Sports Medicine (ACSM) with electrocardiogram (ECG) heart monitoring and periodic blood pressure measures. Open-circuit spirometry will be used to determine VO2max and carbon dioxide production. Walking time until voluntary exhaustion or pain limitation will be recorded. Rating of perceived exertion (RPE) values will be collected at rest, at each exercise stage and during recovery. The treadmill tests will be performed at baseline and following the interventions.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States