Comparison of Two Exercise Interventions to Improve Gait in Older Persons

Gait Clinical Trial

— PRIME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076413
• Other study ID #: PRO09080228
• Secondary ID: K23AG026766
• Status: Completed
• Phase: N/A
• First received: February 24, 2010
• Last updated: January 21, 2016
• Start date: March 2010
• Est. completion date: March 2012

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gait

Intervention

Behavioral:
• skill based exercise
2 times per week for 12 weeks Pre gait and gait activities
• aerobic conditioning
2 times per week for 12 weeks. aerobic conditioning exercise consisting of treadmill walking

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Outcome

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