Restoring Central Motor Control Extension

NCT ID: NCT04302831

Last Updated: 2021-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-04

Study Completion Date

2020-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Gait, Unsteady

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Strength training

Intervention Type BEHAVIORAL

weight lifting to increase muscle strength

Endurance training

Intervention Type BEHAVIORAL

treadmill walking to increase endurance

Flexibility training

Intervention Type BEHAVIORAL

stretches to improve flexibility

Physical activity behavioral intervention

Intervention Type BEHAVIORAL

Intervention to encourage participants to be more physically active

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.

Group Type EXPERIMENTAL

Strength training

Intervention Type BEHAVIORAL

weight lifting to increase muscle strength

Endurance training

Intervention Type BEHAVIORAL

treadmill walking to increase endurance

Flexibility training

Intervention Type BEHAVIORAL

stretches to improve flexibility

Physical activity behavioral intervention

Intervention Type BEHAVIORAL

Intervention to encourage participants to be more physically active

Task Specific timing and coordination training

Intervention Type BEHAVIORAL

stepping and walking patterns to improve timing and coordination of gait

Interventions

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Strength training

weight lifting to increase muscle strength

Intervention Type BEHAVIORAL

Endurance training

treadmill walking to increase endurance

Intervention Type BEHAVIORAL

Flexibility training

stretches to improve flexibility

Intervention Type BEHAVIORAL

Physical activity behavioral intervention

Intervention to encourage participants to be more physically active

Intervention Type BEHAVIORAL

Task Specific timing and coordination training

stepping and walking patterns to improve timing and coordination of gait

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Andrea Rosso

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea L Rosso, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R01AG057671-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY19110142

Identifier Type: -

Identifier Source: org_study_id

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