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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01635348
First received: June 22, 2012
Last updated: July 6, 2012
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
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, visuo-spatial orientation, and set shifting measures of cognitive function performed while walking over an oveal 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


Estimated Enrollment: 24
Study Start Date: January 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: motor skill arm 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 arm 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

  Eligibility

Ages Eligible for Study:   65 Years and older
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 MCI
  • pain while walking that limits walking
  • active medical conditions, not controlled or managed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Jessie M VanSwearingen, PhD, PT 412-383-6634 jessievs@pitt.edu
Contact: Victoria Hornyak, PT, DPT 412-624-1026 vhornyak@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh, Department of Physical Therapy Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Principal Investigator: Jessie M VanSwearingen, PhD, PT         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Jessie M VanSwearingen, PhD, PT University of Pittsburgh, Department of Physical Therapy
  More Information

No publications provided

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 6, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014