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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01635348
First received: June 22, 2012
Last updated: July 28, 2015
Last verified: June 2012
  Purpose
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.

Condition Intervention Phase
Gait Disorder, Sensorimotor
Cognitive Disorder
Behavioral: motor skill gait exercise
Behavioral: aerobic gait intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Benefits of Two Types of Therapeutic Exercise on Gait and Cognition

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • integrated measure of thinking while walking [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The outcome measure is a cognitive task such as working memory, visual-spatial orientation, and set shifting measures of cognitive function performed while walking over an oval track.


Secondary Outcome Measures:
  • gait [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    energy cost of walking, gait smoothness, gait speed and spatial and temporal gait characteristics under usual and challenging gait conditions, gait abnormalities, and walking endurance


Enrollment: 22
Study Start Date: January 2011
Study Completion Date: October 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: motor skill gait exercise arm
motor skill gait exercise intervention: stepping and walking patterns, and speed interval treadmill-assisted walking to enhance timing and coordination in walking
Behavioral: motor skill gait exercise
The motor skill gait exercise is a task-oriented motor sequence learning approach to exercise to improve walking. The approach involves goal-directed stepping and walking patterns to facilitate use of the appropriate muscles at the appropriate timing relative to body position during gait through the task performance. Treadmill-assisted walking in brief intervals of small increased speed walking interspersed with usual walking speed are performed to induce the automatic rhythm and timing of gait. The exercise sessions are about 60 minutes, 2-3 times a week for 12 weeks or a total of 30-36 sessions.
Other Names:
  • task-oriented motor sequence gait exercise
  • motor learning gait exercise
  • timing and coordination therapeutic gait activity
Active Comparator: aerobic gait exercise arm
aerobic gait exercise intervention: treadmill-assisted and overground walking exercise to enhance walking practice and improve endurance in walking
Behavioral: aerobic gait intervention
The aerobic gait intervention approach involves treadmill and overground walking with the gradual increases in the distance walked and speed of walking. The exercise approach provides walking practice, including on the treadmill to facilitate the timing of stepping during gait, while also facilitating a fitness or conditioning response, and endurance for walking activities. The exercise sessions are about 60 minutes, 2-3 times weekly for 12 weeks, or about 30-36 sessions.
Other Names:
  • walking endurance exercise
  • aerobic walking training
  • impairment-oriented gait exercise

Detailed 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).
  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01635348

Locations
United States, Pennsylvania
University of Pittsburgh, Department of Physical Therapy
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
National Institute on Aging (NIA)
Investigators
Principal Investigator: Jessie M VanSwearingen, PhD, PT University of Pittsburgh, Department of Physical Therapy
  More Information

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01635348     History of Changes
Other Study ID Numbers: PRO10090070  P30AG024827 
Study First Received: June 22, 2012
Last Updated: July 28, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
gait speed
cognitive processing speed

Additional relevant MeSH terms:
Disease
Cognition Disorders
Gait Disorders, Neurologic
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2016