Restoring Central Motor Control Extension (PRIMA-NIRS)

Restoring Central Motor Control to Improve Community Mobility of Older Adults

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.

Study Overview

• Status: Withdrawn
• Conditions: Gait, Unsteady
• Intervention / Treatment: Behavioral: Strength training; Behavioral: Endurance training; Behavioral: Flexibility training; Behavioral: Physical activity behavioral intervention; Behavioral: Task Specific timing and coordination training

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard; The standard arm consists of strength, endurance and flexibility exercises 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention.	Behavioral: Strength training; weight lifting to increase muscle strength; Behavioral: Endurance training; treadmill walking to increase endurance; Behavioral: Flexibility training; stretches to improve flexibility; Behavioral: Physical activity behavioral intervention; Intervention to encourage participants to be more physically active
EXPERIMENTAL: Standard-plus; The standard-plus arm consists of strength, endurance and flexibility exercises plus task specific timing and coordination exercises to improve gait 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention.	Behavioral: Strength training; weight lifting to increase muscle strength; Behavioral: Endurance training; treadmill walking to increase endurance; Behavioral: Flexibility training; stretches to improve flexibility; Behavioral: Physical activity behavioral intervention; Intervention to encourage participants to be more physically active; Behavioral: Task Specific timing and coordination training; stepping and walking patterns to improve timing and coordination of gait

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking	Physiologic measure indicative of usage of the prefrontal cortex during a task recorded by optical imaging (near infrared spectroscopy).	change from baseline to 12 weeks
Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking	Physiologic measure indicative of usage of the prefrontal cortex during a task recorded by optical imaging (near infrared spectroscopy).	change from baseline to 36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait speed	Walking speed (m/s) during usual pace	12, 24, and 36 weeks
Gait speed	Walking speed (m/s) with a cognitive challenge.	12, 24, and 36 weeks
Gait speed	Walking speed (m/s) on an uneven surface.	12, 24, and 36 weeks
Gait variability	Fluctuations in gait characteristics from step to step during usual pace. Physiologic measure of temporal gait characteristics (standard deviation).	12, 24, and 36 weeks
Gait variability	Fluctuations in gait characteristics from step to step while walking with a cognitive challenge. Physiologic measure of temporal gait characteristics (standard deviation).	12, 24, and 36 weeks
Gait variability	Fluctuations in gait characteristics from step to step while walking on an uneven surface. Physiologic measure of temporal gait characteristics (standard deviation).	12, 24, and 36 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity Space	Extent of travel beyond the home collected by GPS device based on a standard deviation ellipse of spatial measurement points.	12, 24, and 36 weeks

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Andrea L Rosso, PhD, MPH, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 4, 2020
• Primary Completion (ACTUAL): December 1, 2020
• Study Completion (ACTUAL): December 1, 2020

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (ACTUAL): March 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Gait Disorders, Neurologic
• Other Study ID Numbers: STUDY19110142; R01AG057671-01A1 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No