Testing Adaptive Physical Activity in Stroke

NCT ID: NCT01042990

Last Updated: 2010-01-06

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-09-30

Brief Summary

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"Testing Adaptive Physical Activity in Stroke" tests the idea that adaptive physical activity (APA) will improve fitness, balance and walking function, daily step activity, and outcomes related to quality of life in individuals with chronic stroke. Adaptive physical activity is an exercise model that combines aerobic exercise with balance and gait training in a socially reinforcing group setting. Individualized homework assignments encourage integration of exercise into daily life routines. Our specific aims are:

1. to determine whether APA improves cardiovascular fitness and metabolic health
2. to measure the effects of APA on gait and balance, ambulatory activity, and ADL function
3. to determine whether APA affects self-reported outcomes related to self-efficacy, fatigue, and stroke-specific quality of life

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Home Exercise Only

Participants receive education and instruction on a home exercise program which they do on their own, with intermittent encouragement from study personnel.

Group Type ACTIVE_COMPARATOR

Adaptive Physical Activity

Intervention Type OTHER

Structured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months

APA

Participants exercise in a gym setting 3x/week for six months, performing gait and balance exercises along with a progressive walking program.

Group Type EXPERIMENTAL

Adaptive Physical Activity

Intervention Type OTHER

Structured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months

APA+TM

Participants exercise in a gym setting 3x/week for six months, performing a combined program of adaptive physical activity (gait and balance training) and progressive treadmill walking.

Group Type EXPERIMENTAL

Adaptive Physical Activity

Intervention Type OTHER

Structured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months

Interventions

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Adaptive Physical Activity

Structured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Ischemic stroke greater than or equal to 6 months prior in men or women ages 40- or older. Hemorrhagic stroke greater than or equal to one year prior in men or women ages 40-or older.
2. Residual hemiparetic gait deficits.
3. Already completed all conventional inpatient and outpatient physical therapy.
4. Adequate language and neurocognitive function to participate in exercise testing and training (specific screening instruments used.)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland

OTHER

Sponsor Role collaborator

Baltimore VA Medical Center

FED

Sponsor Role lead

Responsible Party

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University of Maryland

Principal Investigators

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Richard F Macko, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Kathleen M Michael, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Andrew P Goldberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

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Baltimore VAMC

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kathleen M Michael, PhD

Role: CONTACT

410-605-7000 ext. 4844

Jeffrey Beans, BS

Role: CONTACT

410-605-7000 ext. 4168

Facility Contacts

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Kathleen M Michael, PhD

Role: primary

410-605-7000 ext. 4844

References

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Michael K, Goldberg AP, Treuth MS, Beans J, Normandt P, Macko RF. Progressive adaptive physical activity in stroke improves balance, gait, and fitness: preliminary results. Top Stroke Rehabil. 2009 Mar-Apr;16(2):133-9. doi: 10.1310/tsr1602-133.

Reference Type RESULT
PMID: 19581199 (View on PubMed)

Other Identifiers

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HP-00040264

Identifier Type: -

Identifier Source: org_study_id

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