Skip to content

Comparison of Two Exercise Interventions to Improve Gait in Older Persons

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01076413
Acronym
PRIME
Enrollment
40
Registered
2010-02-26
Start date
2010-03-31
Completion date
2012-03-31
Last updated
2016-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait

Keywords

gait, exercise, skill-based, aerobic

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.

Interventions

BEHAVIORALskill based exercise

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

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

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Gait12 weeksgait characteristics, smoothness of walking, 6 MWT, complex walking tests, GARS-M, SPPB, energy cost, SAFFE, GES, figure of 8
Physical function12 weeksLLFDI function and disability scales
Physical Activity12 weeksActigraph accelerometer

Secondary

MeasureTime frameDescription
Disability and health care costs6 months post exerciseLate 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026