Comparison of Two Exercise Interventions to Improve Gait in Older Persons

Not Applicable

Completed

• Conditions: Gait
• Interventions: Behavioral: aerobic conditioning; Behavioral: skill based exercise

• Registration Number: NCT01076413
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Study Start: 2010-03
• Primary Completion: 2011-09
• Study Completion: 2012-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-21
• Last Update Posted: 2016-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aerobic exercise training	aerobic conditioning	warm-up, strengthening and aerobic conditioning (treadmill walking)
skill-based exercise	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

Primary Outcome Measures

Name	Time	Method
Physical function	12 weeks	LLFDI function and disability scales
Physical Activity	12 weeks	Actigraph accelerometer
Gait	12 weeks	gait characteristics, smoothness of walking, 6 MWT, complex walking tests, GARS-M, SPPB, energy cost, SAFFE, GES, figure of 8

Secondary Outcome Measures

Name	Time	Method
Disability and health care costs	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

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States