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Clinical Trials/NCT01076413
NCT01076413
Completed
Not Applicable

Comparison of Two Exercise Interventions to Improve Gait in Older Persons: The PRIME (Program to Improve Mobility in The Elderly) Study

University of Pittsburgh1 site in 1 country40 target enrollmentMarch 2010
ConditionsGait

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gait
Sponsor
University of Pittsburgh
Enrollment
40
Locations
1
Primary Endpoint
Physical function
Status
Completed
Last Updated
10 years ago

Overview

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 for 3 months will improve walking abilities by improving balance and strength.

Detailed Description

The purpose of this research study is to compare two different exercise treatments for walking problems in older adults. We want to determine if participation in the exercise programs for 3 months will improve walking abilities by improving balance and strength. Adults aged 65 years or older, who are able to walk without the help of another person, are being asked to participate. If you are able to walk independently and you have medical clearance from your physician to participate in activities requiring low to moderate physical activity, you are invited to participate. We plan to enroll 40 older adults, all who have small problems with walking due to balance or strength, in this research study.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
March 2012
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer S. Brach

Associate Professor

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • 65 years of age and older
  • Ambulatory without an assistive device or the assistance of another person
  • Usual 4 meter gait speed ≥1.0 m/s
  • Completes a figure-of-eight walk in \> 8.0 seconds

Exclusion Criteria

  • Inability to participate in testing:
  • persistent lower extremity pain that is present on most days of the week and crepitus, tenderness or enlargement of joints of the lower extremity (arthritis).84
  • back pain that is present on most days of the weeks and interferes with walking and activities of daily living or back pain that increases with walking (lumbar stenosis)
  • calf pain or cramping which worsens with walking and is relieved by rest (PAD)
  • refusal to walk on a treadmill
  • Safety concerns:
  • dyspnea at rest or during activities of daily living or use supplemental oxygen (CHF, COPD)
  • any acute illness or medical condition that is not stable according to the approving physician
  • resting systolic blood pressure ≥ 200 mm Hg or diastolic blood pressure ≥ 100 mm Hg or resting heart rate \> 100 or \< 40 beats per minute85
  • diagnosed dementia or cognitive impairment defined as a MMSE score \< 24

Outcomes

Primary Outcomes

Physical function

Time Frame: 12 weeks

LLFDI function and disability scales

Physical Activity

Time Frame: 12 weeks

Actigraph accelerometer

Gait

Time Frame: 12 weeks

gait characteristics, smoothness of walking, 6 MWT, complex walking tests, GARS-M, SPPB, energy cost, SAFFE, GES, figure of 8

Secondary Outcomes

  • Disability and health care costs(6 months post exercise)

Study Sites (1)

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