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Restoring Central Motor Control Extension (PRIMA-NIRS)

Primary Purpose

Gait, Unsteady

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strength training
Endurance training
Flexibility training
Physical activity behavioral intervention
Task Specific timing and coordination training
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Gait, Unsteady

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard

Standard-plus

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 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).

Secondary Outcome Measures

Gait speed
Walking speed (m/s) during usual pace
Gait speed
Walking speed (m/s) with a cognitive challenge.
Gait speed
Walking speed (m/s) on an uneven surface.
Gait variability
Fluctuations in gait characteristics from step to step during usual pace. Physiologic measure of temporal gait characteristics (standard deviation).
Gait variability
Fluctuations in gait characteristics from step to step while walking with a cognitive challenge. Physiologic measure of temporal gait characteristics (standard deviation).
Gait variability
Fluctuations in gait characteristics from step to step while walking on an uneven surface. Physiologic measure of temporal gait characteristics (standard deviation).

Full Information

First Posted
February 26, 2020
Last Updated
March 15, 2021
Sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04302831
Brief Title
Restoring Central Motor Control Extension
Acronym
PRIMA-NIRS
Official Title
Restoring Central Motor Control to Improve Community Mobility of Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
COVID-19 safety restrictions
Study Start Date
March 4, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait, Unsteady

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard-plus
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Strength training
Intervention Description
weight lifting to increase muscle strength
Intervention Type
Behavioral
Intervention Name(s)
Endurance training
Intervention Description
treadmill walking to increase endurance
Intervention Type
Behavioral
Intervention Name(s)
Flexibility training
Intervention Description
stretches to improve flexibility
Intervention Type
Behavioral
Intervention Name(s)
Physical activity behavioral intervention
Intervention Description
Intervention to encourage participants to be more physically active
Intervention Type
Behavioral
Intervention Name(s)
Task Specific timing and coordination training
Intervention Description
stepping and walking patterns to improve timing and coordination of gait
Primary Outcome Measure Information:
Title
Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking
Description
Physiologic measure indicative of usage of the prefrontal cortex during a task recorded by optical imaging (near infrared spectroscopy).
Time Frame
change from baseline to 12 weeks
Title
Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking
Description
Physiologic measure indicative of usage of the prefrontal cortex during a task recorded by optical imaging (near infrared spectroscopy).
Time Frame
change from baseline to 36 weeks
Secondary Outcome Measure Information:
Title
Gait speed
Description
Walking speed (m/s) during usual pace
Time Frame
12, 24, and 36 weeks
Title
Gait speed
Description
Walking speed (m/s) with a cognitive challenge.
Time Frame
12, 24, and 36 weeks
Title
Gait speed
Description
Walking speed (m/s) on an uneven surface.
Time Frame
12, 24, and 36 weeks
Title
Gait variability
Description
Fluctuations in gait characteristics from step to step during usual pace. Physiologic measure of temporal gait characteristics (standard deviation).
Time Frame
12, 24, and 36 weeks
Title
Gait variability
Description
Fluctuations in gait characteristics from step to step while walking with a cognitive challenge. Physiologic measure of temporal gait characteristics (standard deviation).
Time Frame
12, 24, and 36 weeks
Title
Gait variability
Description
Fluctuations in gait characteristics from step to step while walking on an uneven surface. Physiologic measure of temporal gait characteristics (standard deviation).
Time Frame
12, 24, and 36 weeks
Other Pre-specified Outcome Measures:
Title
Activity Space
Description
Extent of travel beyond the home collected by GPS device based on a standard deviation ellipse of spatial measurement points.
Time Frame
12, 24, and 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea L Rosso, PhD, MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Restoring Central Motor Control Extension

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