Gait Clinical Trial
— PRIMEOfficial title:
Comparison of Two Exercise Interventions to Improve Gait in Older Persons: The PRIME (Program to Improve Mobility in The Elderly) Study
Verified date | January 2016 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 2012 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Institute on Aging (NIA) |
United States,
Brach JS, Lowry K, Perera S, Hornyak V, Wert D, Studenski SA, VanSwearingen JM. Improving motor control in walking: a randomized clinical trial in older adults with subclinical walking difficulty. Arch Phys Med Rehabil. 2015 Mar;96(3):388-94. doi: 10.1016 — View Citation
Brach JS, Van Swearingen JM, Perera S, Wert DM, Studenski S. Motor learning versus standard walking exercise in older adults with subclinical gait dysfunction: a randomized clinical trial. J Am Geriatr Soc. 2013 Nov;61(11):1879-86. doi: 10.1111/jgs.12506. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gait | gait characteristics, smoothness of walking, 6 MWT, complex walking tests, GARS-M, SPPB, energy cost, SAFFE, GES, figure of 8 | 12 weeks | No |
Primary | Physical function | LLFDI function and disability scales | 12 weeks | No |
Primary | Physical Activity | Actigraph accelerometer | 12 weeks | No |
Secondary | Disability and health care costs | 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 | 6 months post exercise | No |
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