Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Restoring Central Motor Control Extension (PRIMA-NIRS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04302831
Recruitment Status : Suspended (COVID-19 safety restrictions)
First Posted : March 10, 2020
Last Update Posted : April 27, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Andrea Rosso, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Gait, Unsteady Behavioral: Strength training Behavioral: Endurance training Behavioral: Flexibility training Behavioral: Physical activity behavioral intervention Behavioral: Task Specific timing and coordination training Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Restoring Central Motor Control to Improve Community Mobility of Older Adults
Actual Study Start Date : March 4, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : July 2021

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




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

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


Secondary Outcome Measures :
  1. Gait speed [ Time Frame: 12, 24, and 36 weeks ]
    Walking speed (m/s) during usual pace

  2. Gait speed [ Time Frame: 12, 24, and 36 weeks ]
    Walking speed (m/s) with a cognitive challenge.

  3. Gait speed [ Time Frame: 12, 24, and 36 weeks ]
    Walking speed (m/s) on an uneven surface.

  4. Gait variability [ Time Frame: 12, 24, and 36 weeks ]
    Fluctuations in gait characteristics from step to step during usual pace. Physiologic measure of temporal gait characteristics (standard deviation).

  5. Gait variability [ Time Frame: 12, 24, and 36 weeks ]
    Fluctuations in gait characteristics from step to step while walking with a cognitive challenge. Physiologic measure of temporal gait characteristics (standard deviation).

  6. Gait variability [ Time Frame: 12, 24, and 36 weeks ]
    Fluctuations in gait characteristics from step to step while walking on an uneven surface. Physiologic measure of temporal gait characteristics (standard deviation).


Other Outcome Measures:
  1. Activity Space [ Time Frame: 12, 24, and 36 weeks ]
    Extent of travel beyond the home collected by GPS device based on a standard deviation ellipse of spatial measurement points.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04302831


Locations
Layout table for location information
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
Sponsors and Collaborators
University of Pittsburgh
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Andrea L Rosso, PhD, MPH University of Pittsburgh
Layout table for additonal information
Responsible Party: Andrea Rosso, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04302831    
Other Study ID Numbers: STUDY19110142
R01AG057671-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Gait Disorders, Neurologic
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms