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Thinking, Walking Outcomes by Type of Exercise (2-STEP)

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University of Pittsburgh

Status and phase

Completed
Phase 2

Conditions

Cognitive Disorder
Gait Disorder, Sensorimotor

Treatments

Behavioral: aerobic gait intervention
Behavioral: motor skill gait exercise

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01635348
PRO10090070
P30AG024827 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this research study is to compare two different exercise treatments for walking problems in older adults. The investigators want to determine if participation in the exercise programs will improve walking and thinking abilities.

Full description

Specific Aims We will examine the impact of moderate intensity aerobic and of motor skill exercise interventions on improving gait and cognition in older adults with slow gait and psychomotor slowing. In a thrice weekly, 12 week, randomized clinical trial, we propose the following aims: 1) to define the impact of moderate intensity aerobic and motor skill gait exercise on thinking while walking, and 2) to define the impact of moderate intensity aerobic and motor skill gait exercise on gait and cognition. Brief Background The optimal exercise to improve gait and brain health in older adults is not known. Two types of exercise with potential for affects on gait and brain health, aerobic and motor skill exercise, developed out of distinct disciplines and have been studied separately, but not in older adults with the same age-related, centrally-generated slow gait dysfunction or for their effects on an integrated measure of gait and cognition, 'walking while thinking'. Summary of Methods We propose two parallel, single arm clinical trials to define the impact of aerobic and motor-skill exercise on gait and cognitive functions, in community-dwelling older adults with slow gait and psychomotor slowing, randomly assigned to moderate intensity aerobic gait (n=12) or motor skill gait (n=12) exercise, three times a week, for 12 weeks, in small groups of 2-3 supervised by a physical therapist. Primary outcomes are integrated measures of thinking while walking, with secondary outcomes of specific measures of gait and cognitive function collected pre, 4, 8 and 12 weeks post interventions, to examine impact of exercise and dose-response effects on gait and cognition. Future Use of Data The intent of the proposed pilot is to generate complementary data essential to support an R01 clinical trial grant submission. Specifically in this pilot we will: 1) recruit older adults with both slow gait speed and evidence of psychomotor slowing, 2) explore and define a primary outcome measure that integrates both gait and cognition, and thus better represents the goal of the exercise interventions - thinking while walking, 3) determine potential mean and variability estimates for gait and cognitive outcomes, particularly the less well-characterized gait outcomes of aerobic exercise (energy expenditure for walking, gait variability, gait abnormalities), and cognitive outcomes of motor skill exercise (speed of processing, executive function).

Enrollment

22 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • slow gait speed (<= 1.0m/s and >= .6m/s)
  • slow cognitive processing (digit symbol substitution < age-adjusted norm
  • medical clearance from primary physician for participation in exercise

Exclusion criteria

  • dementia or Mild Cognitive Impairment MCI
  • pain while walking that limits walking
  • active medical conditions, not controlled or managed

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

22 participants in 2 patient groups

motor skill gait exercise arm
Experimental group
Description:
motor skill gait exercise intervention: stepping and walking patterns, and speed interval treadmill-assisted walking to enhance timing and coordination in walking
Treatment:
Behavioral: motor skill gait exercise
aerobic gait exercise arm
Active Comparator group
Description:
aerobic gait exercise intervention: treadmill-assisted and overground walking exercise to enhance walking practice and improve endurance in walking
Treatment:
Behavioral: aerobic gait intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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