Restoring Central Motor Control Extension

NCT04302831 | Withdrawn DMC

• 2 other identifiers: STUDY19110142R01AG057671-01A1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gait, Unsteady

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Gait speed

  12, 24, and 36 weeks

• Gait speed

  12, 24, and 36 weeks

• Gait speed

  12, 24, and 36 weeks

• Gait variability

  12, 24, and 36 weeks

• Gait variability

  12, 24, and 36 weeks

Other Outcomes (1)

• Activity Space

  12, 24, and 36 weeks

Study Arms (2)

Standard

ACTIVE COMPARATOR

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; Behavioral: Endurance training; Behavioral: Flexibility training; Behavioral: Physical activity behavioral intervention

Standard-plus

EXPERIMENTAL

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

Interventions

Strength training BEHAVIORAL

weight lifting to increase muscle strength

Standard; Standard-plus

Endurance training BEHAVIORAL

treadmill walking to increase endurance

Standard; Standard-plus

Flexibility training BEHAVIORAL

stretches to improve flexibility

Standard; Standard-plus

Physical activity behavioral intervention BEHAVIORAL

Intervention to encourage participants to be more physically active

Standard; Standard-plus

Task Specific timing and coordination training BEHAVIORAL

stepping and walking patterns to improve timing and coordination of gait

Standard-plus

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Interventions

Resistance Training; Endurance Training

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Andrea L Rosso, PhD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 10, 2020
• Study Start: March 4, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)