Comparison of Two Exercise Interventions to Improve Gait in Older Persons (PRIME)

• ClinicalTrials.gov Identifier: NCT01076413
• Recruitment Status: Completed
• First Posted: February 26, 2010
• Last Update Posted: January 25, 2016
• Sponsor: University of Pittsburgh
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Jennifer S. Brach, University of Pittsburgh

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gait	Behavioral: skill based exercise; Behavioral: aerobic conditioning	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Two Exercise Interventions to Improve Gait in Older Persons: The PRIME (Program to Improve Mobility in The Elderly) Study
• Study Start Date: March 2010
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: March 2012

Arms and Interventions

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	Behavioral: skill based exercise; 2 times per week for 12 weeks Pre gait and gait activities
Active Comparator: aerobic exercise training; warm-up, strengthening and aerobic conditioning (treadmill walking)	Behavioral: aerobic conditioning; 2 times per week for 12 weeks. aerobic conditioning exercise consisting of treadmill walking

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Pennsylvania

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15260

Sponsors and Collaborators

University of Pittsburgh

National Institute on Aging (NIA)

More Information

Publications of Results:

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.

• Responsible Party: Jennifer S. Brach, Associate Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT01076413
• Other Study ID Numbers: PRO09080228; K23AG026766 ( U.S. NIH Grant/Contract )
• First Posted: February 26, 2010
• Last Update Posted: January 25, 2016
• Last Verified: January 2016

Keywords provided by Jennifer S. Brach, University of Pittsburgh:

gait; exercise; skill-based; aerobic