Locomotor Adaptation Training to Prevent Mobility Disability

NCT02554916 | Completed DMC

• 2 other identifiers: IRB201400915-N1R21AG048133-01A1
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-related Mobility Decline

Keywords

Mobility decline

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Change in physical performance

  baseline and up to 6 weeks following the intervention

• Change in cognitive impairment

  baseline and up to 6 weeks following the intervention

• Change in Cognitive impairment of executive function

  baseline and up to 6 weeks following the intervention

• Change in Disability

  baseline and up to 6 weeks following the intervention

• Change in likelihood of falling

  baseline and up to 6 weeks following the intervention

Study Arms (3)

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; Device: Dual-Belt Treadmill

Treadmill Exercise

The participants assigned to this group will use the treadmill 3 times a week for 16 weeks.

Behavioral: Treadmill Exercise; Device: Dual-Belt Treadmill

Usual Care

The participants assigned to this group will not use the treadmills.

Other: Usual Care

Interventions

Dual-Belt Exercise BEHAVIORAL

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.

Also known as: Dual-Belt Treadmill

Dual-belt Exercise

Treadmill Exercise BEHAVIORAL

The treadmill exercise will maintain the speed of the right and left leg together while walking.

Treadmill Exercise

Usual Care OTHER

This group will not be assigned to a treadmill but is as a non-exercising control group.

Usual Care

Dual-Belt Treadmill DEVICE

Dual-belt Exercise; Treadmill Exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Study Officials

• Chris J Hass, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 18, 2015
• Study Start: July 1, 2010
• Primary Completion: July 17, 2019
• Study Completion: July 17, 2019
• Last Updated: July 22, 2019

Record last verified: 2019-07

Locations

US (1)