Comparison of Two Exercise Interventions to Improve Gait in Older Persons

NCT ID: NCT01076413

Last Updated: 2016-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Gait

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

skill based exercise

Intervention Type BEHAVIORAL

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

aerobic exercise training

warm-up, strengthening and aerobic conditioning (treadmill walking)

Group Type ACTIVE_COMPARATOR

aerobic conditioning

Intervention Type BEHAVIORAL

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

Interventions

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skill based exercise

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

Intervention Type BEHAVIORAL

aerobic conditioning

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Jennifer S. Brach

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 25448244 (View on PubMed)

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.

Reference Type RESULT
PMID: 24219189 (View on PubMed)

Other Identifiers

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K23AG026766

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO09080228

Identifier Type: -

Identifier Source: org_study_id

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