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Completed

NCT Number: NCT01076413

Comparison of Two Exercise Interventions to Improve Gait in Older Persons

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • hospitalized in the past 6 months for acute illness or surgery, other than minor surgical procedures
  • severe visual impairment with visual acuity < 20/70 with best correction
  • history of stroke
  • fixed or fused lower extremity joints such as hip, knee or ankle
  • lower extremity strength <4/5 on manual muscle testing
  • lower extremity amputation
  • progressive movement disorder such as MS, ALS or Parkinson's disease

Treatment and study plan

skill based exercise

Behavioral

2 times per week for 12 weeks Pre gait and gait activities

Aerobic conditioning

Behavioral

2 times per week for 12 weeks. aerobic conditioning exercise consisting of treadmill walking

Primary outcomes

  1. 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

  2. Physical function

    Time frame: 12 weeks

    LLFDI function and disability scales

  3. Physical Activity

    Time frame: 12 weeks

    Actigraph accelerometer

Secondary outcomes

  1. Disability and health care costs

    Time frame: 6 months post exercise

    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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: PRIME

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Feb 26, 2010
Registry last updated
Jan 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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