Locomotor Adaptation Training to Prevent Mobility Disability

Effectiveness of Rehabilitation Interventions for Mobility Impairment in Parkinson's Disease

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.

Study Overview

• Status: Completed
• Conditions: Age-related Mobility Decline
• Intervention / Treatment: Behavioral: Dual-Belt Exercise; Device: Dual-Belt Treadmill; Behavioral: Treadmill Exercise; Other: Usual Care

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 Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Older adults with sedentary lifestyle willing to be be randomized to and treatment groups.

Description

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

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dual-belt Exercise; The participants assigned to this group will use the dual-belt treadmill 3 times a week for 16 weeks.	Behavioral: 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.; Other Names: Dual-Belt Treadmill; Device: Dual-Belt Treadmill
Treadmill Exercise; The participants assigned to this group will use the treadmill 3 times a week for 16 weeks.	Device: Dual-Belt Treadmill; Behavioral: Treadmill Exercise; The treadmill exercise will maintain the speed of the right and left leg together while walking.
Usual Care; The participants assigned to this group will not use the treadmills.	Other: Usual Care; This group will not be assigned to a treadmill but is as a non-exercising control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gait Speed	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).	baseline and up to 6 weeks following the intervention
Change in temporal variability	Temporal will be determined from kinematic and kinetic measurement methods. Lower values correspond to better walking performance.	baseline and up to 6 weeks following the intervention
Change in spatial variability	Spatial will be determined from kinematic and kinetic measurement methods. Lower values correspond to better walking performance.	baseline and up to 6 weeks following the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical performance	Using the Short Physical Performance Battery. A score is generated from 0 (worst performance)-12 (best performance).	baseline and up to 6 weeks following the intervention
Change in cognitive impairment	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.	baseline and up to 6 weeks following the intervention
Change in Cognitive impairment of executive function	Using the Montreal Cognitive assessment. 30 items. A score of less than 26 on this assessment will indicate cognitive executive function.	baseline and up to 6 weeks following the intervention
Change in Disability	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.	baseline and up to 6 weeks following the intervention
Change in likelihood of falling	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).	baseline and up to 6 weeks following the intervention
Change in knee extensor strength	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.	baseline and up to 6 weeks following the intervention
Change in ankle plantarflexor strength	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.	baseline and up to 6 weeks following the intervention
Change in Timed up and Go	Participants will be timed in seconds. More time to complete the task indicates low function, while less time indicates high function.	baseline and up to 6 weeks following the intervention
Change in timed chair rise	Participants will be timed in seconds. More time to complete the task indicates low function, while less time indicates high function.	baseline and up to 6 weeks following the intervention
Change in timed stair climb	Participants will be timed in seconds. More time to complete the task indicates low function, while less time indicates high function.	baseline and up to 6 weeks following the intervention
Change in energetic cost of walking	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.	baseline and up to 6 weeks following the intervention
Change in Ambulatory activity	7 day assessment using an activity monitor. The device will count the number of steps taken.	baseline and up to 6 weeks following the intervention

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Chris J Hass, Ph.D., University of Florida

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): July 17, 2019
• Study Completion (Actual): July 17, 2019

Study Registration Dates

• First Submitted: September 17, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (Estimate): September 18, 2015

Study Record Updates

• Last Update Posted (Actual): July 22, 2019
• Last Update Submitted That Met QC Criteria: July 19, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Mobility decline
• Other Study ID Numbers: IRB201400915-N; 1R21AG048133-01A1 (U.S. NIH Grant/Contract)