Clinical trial NCT01076413: Comparison of Two Exercise Interventions to Improve Gait in Older Persons
Official title: Comparison of Two Exercise Interventions to Improve Gait in Older Persons: The PRIME (Program to Improve Mobility in The Elderly) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait
Keywords: gait
exercise
skill-based
aerobic
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2010-02-26
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Gait
timeFrame: 12 weeks
measure: Physical function
timeFrame: 12 weeks
measure: Physical Activity
timeFrame: 12 weeks
Secondary outcomes:
measure: Disability and health care costs
timeFrame: 6 months post exercise
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References:
citation: 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.
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. Epub 2013 Oct 28.