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

Primary Purpose

Gait Disorder, Sensorimotor, Cognitive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
motor skill gait exercise
aerobic gait intervention
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gait Disorder, Sensorimotor focused on measuring gait speed, cognitive processing speed

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Pittsburgh, Department of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

motor skill gait exercise arm

aerobic gait exercise arm

Arm Description

motor skill gait exercise intervention: stepping and walking patterns, and speed interval treadmill-assisted walking to enhance timing and coordination in walking

aerobic gait exercise intervention: treadmill-assisted and overground walking exercise to enhance walking practice and improve endurance in walking

Outcomes

Primary Outcome Measures

integrated measure of thinking while walking
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
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

Full Information

First Posted
June 22, 2012
Last Updated
July 28, 2015
Sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT01635348
Brief Title
Thinking, Walking Outcomes by Type of Exercise
Acronym
2-STEP
Official Title
Benefits of Two Types of Therapeutic Exercise on Gait and Cognition
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait Disorder, Sensorimotor, Cognitive Disorder
Keywords
gait speed, cognitive processing speed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
motor skill gait exercise arm
Arm Type
Experimental
Arm Description
motor skill gait exercise intervention: stepping and walking patterns, and speed interval treadmill-assisted walking to enhance timing and coordination in walking
Arm Title
aerobic gait exercise arm
Arm Type
Active Comparator
Arm Description
aerobic gait exercise intervention: treadmill-assisted and overground walking exercise to enhance walking practice and improve endurance in walking
Intervention Type
Behavioral
Intervention Name(s)
motor skill gait exercise
Other Intervention Name(s)
task-oriented motor sequence gait exercise, motor learning gait exercise, timing and coordination therapeutic gait activity
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
aerobic gait intervention
Other Intervention Name(s)
walking endurance exercise, aerobic walking training, impairment-oriented gait exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
integrated measure of thinking while walking
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
gait
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessie M VanSwearingen, PhD, PT
Organizational Affiliation
University of Pittsburgh, Department of Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh, Department of Physical Therapy
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States

12. IPD Sharing Statement

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Thinking, Walking Outcomes by Type of Exercise

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