Thinking, Walking Outcomes by Type of Exercise

NCT01635348 | Completed Phase 2 DMC

• 2 other identifiers: PRO10090070P30AG024827
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Gait Disorder, Sensorimotor; Cognitive Disorder

Keywords

gait speed; cognitive processing speed

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• gait

  12 weeks

Study Arms (2)

motor skill gait exercise arm

EXPERIMENTAL

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

aerobic gait exercise arm

ACTIVE COMPARATOR

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

Behavioral: aerobic gait intervention

Interventions

motor skill gait exercise BEHAVIORAL

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.

Also known as: task-oriented motor sequence gait exercise, motor learning gait exercise, timing and coordination therapeutic gait activity

motor skill gait exercise arm

aerobic gait intervention BEHAVIORAL

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.

Also known as: walking endurance exercise, aerobic walking training, impairment-oriented gait exercise

aerobic gait exercise arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pittsburgh, Department of Physical Therapy

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jessie M VanSwearingen, PhD, PT

  University of Pittsburgh, Department of Physical Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2012
• First Posted: July 9, 2012
• Study Start: January 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 30, 2015

Record last verified: 2012-06

Locations

US (1)