- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01635348
Thinking, Walking Outcomes by Type of Exercise (2-STEP)
July 28, 2015 updated by: University of Pittsburgh
Benefits of Two Types of Therapeutic Exercise on Gait and Cognition
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15260
- University of Pittsburgh, Department of Physical Therapy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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:
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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
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
integrated measure of thinking while walking
Time Frame: 12 weeks
|
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.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gait
Time Frame: 12 weeks
|
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
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jessie M VanSwearingen, PhD, PT, University of Pittsburgh, Department of Physical Therapy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
June 22, 2012
First Submitted That Met QC Criteria
July 6, 2012
First Posted (Estimate)
July 9, 2012
Study Record Updates
Last Update Posted (Estimate)
July 30, 2015
Last Update Submitted That Met QC Criteria
July 28, 2015
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO10090070
- P30AG024827 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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