Comparison of Two Exercise Interventions to Improve Gait in Older Persons (PRIME)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jennifer S. Brach, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01076413
First received: February 24, 2010
Last updated: November 11, 2013
Last verified: November 2013
  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 for 3 months will improve walking abilities by improving balance and strength.


Condition Intervention
Gait
Behavioral: skill based exercise
Behavioral: aerobic conditioning

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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Gait [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    gait characteristics, smoothness of walking, 6 MWT, complex walking tests, GARS-M, SPPB, energy cost, SAFFE, GES, figure of 8

  • Physical function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    LLFDI function and disability scales

  • Physical Activity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Actigraph accelerometer


Secondary Outcome Measures:
  • Disability and health care costs [ Time Frame: 6 months post exercise ] [ Designated as safety issue: No ]
    Late Life Function and disability index, fall history and health care cost questionnaire will be administered through a phone interview 6 months following completion of the exercise program


Enrollment: 40
Study Start Date: March 2010
Study Completion Date: March 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: skill-based exercise
2 times per week for 12 weeks. warm-up, stretching, strengthening, and skill-based exercises. Pre-gait and gait activities including stepping patterns and walking patterns and treadmill training at various walking speeds
Behavioral: skill based exercise
2 times per week for 12 weeks Pre gait and gait activities
Active Comparator: aerobic exercise training
warm-up, strengthening and aerobic conditioning (treadmill walking)
Behavioral: aerobic conditioning
2 times per week for 12 weeks. aerobic conditioning exercise consisting of treadmill walking

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 65 years of age and older
  2. Ambulatory without an assistive device or the assistance of another person
  3. Usual 4 meter gait speed ≥1.0 m/s
  4. Completes a figure-of-eight walk in > 8.0 seconds

Exclusion Criteria:

  1. Inability to participate in testing:

    1. 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
    2. 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)
    3. calf pain or cramping which worsens with walking and is relieved by rest (PAD)
    4. refusal to walk on a treadmill
  2. Safety concerns:

    1. dyspnea at rest or during activities of daily living or use supplemental oxygen (CHF, COPD)
    2. any acute illness or medical condition that is not stable according to the approving physician
    3. resting systolic blood pressure ≥ 200 mm Hg or diastolic blood pressure ≥ 100 mm Hg or resting heart rate > 100 or < 40 beats per minute85
    4. diagnosed dementia or cognitive impairment defined as a MMSE score < 24
    5. hospitalized in the past 6 months for acute illness or surgery, other than minor surgical procedures
    6. severe visual impairment with visual acuity < 20/70 with best correction
    7. history of stroke
    8. fixed or fused lower extremity joints such as hip, knee or ankle
    9. lower extremity strength <4/5 on manual muscle testing
    10. lower extremity amputation
    11. progressive movement disorder such as MS, ALS or Parkinson's disease
  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: NCT01076413

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
  More Information

No publications provided

Responsible Party: Jennifer S. Brach, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01076413     History of Changes
Other Study ID Numbers: PRO09080228, K23AG026766
Study First Received: February 24, 2010
Last Updated: November 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
gait
exercise
skill-based
aerobic

ClinicalTrials.gov processed this record on August 28, 2014