- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01076413
Comparison of Two Exercise Interventions to Improve Gait in Older Persons (PRIME)
Comparison of Two Exercise Interventions to Improve Gait in Older Persons: The PRIME (Program to Improve Mobility in The Elderly) Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15260
- University of Pittsburgh
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
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2 times per week for 12 weeks Pre gait and gait activities
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Active Comparator: aerobic exercise training
warm-up, strengthening and aerobic conditioning (treadmill walking)
|
2 times per week for 12 weeks.
aerobic conditioning exercise consisting of treadmill walking
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 weeks
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Physical function
Time Frame: 12 weeks
|
LLFDI function and disability scales
|
12 weeks
|
Physical Activity
Time Frame: 12 weeks
|
Actigraph accelerometer
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months post exercise
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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/j.apmr.2014.10.018. Epub 2014 Nov 10.
- 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. Epub 2013 Oct 28.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PRO09080228
- K23AG026766 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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