Restoring Central Motor Control Extension (PRIMA-NIRS)

University of Pittsburgh

Status: Withdrawn

Conditions: Gait, Unsteady

Treatments: Behavioral: Endurance training; Behavioral: Task Specific timing and coordination training; Behavioral: Strength training; Behavioral: Physical activity behavioral intervention; Behavioral: Flexibility training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04302831

STUDY19110142

R01AG057671-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Sex: All

Ages: 65+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Standard

Active Comparator group

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.

Treatment:

Behavioral: Physical activity behavioral intervention

Behavioral: Endurance training

Behavioral: Flexibility training

Behavioral: Strength training

Standard-plus

Experimental group

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.

Treatment:

Behavioral: Physical activity behavioral intervention

Behavioral: Task Specific timing and coordination training

Behavioral: Endurance training

Behavioral: Flexibility training

Behavioral: Strength training