Clinical trial NCT04302831: Restoring Central Motor Control Extension
Official title: Restoring Central Motor Control to Improve Community Mobility of Older Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gait, Unsteady
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-03-10
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking
timeFrame: change from baseline to 12 weeks
measure: Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking
timeFrame: change from baseline to 36 weeks
Secondary outcomes:
measure: Gait speed
timeFrame: 12, 24, and 36 weeks
measure: Gait speed
timeFrame: 12, 24, and 36 weeks
measure: Gait speed
timeFrame: 12, 24, and 36 weeks
measure: Gait variability
timeFrame: 12, 24, and 36 weeks
measure: Gait variability
timeFrame: 12, 24, and 36 weeks
measure: Gait variability
timeFrame: 12, 24, and 36 weeks
Other outcomes:
measure: Activity Space
timeFrame: 12, 24, and 36 weeks
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Andrea L Rosso, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: