Testing Adaptive Physical Activity in Stroke (TAPAS)

Baltimore VA Medical Center

Status: Unknown

Conditions: Stroke

Treatments: Other: Adaptive Physical Activity

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01042990

HP-00040264

Details and patient eligibility

About

"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

Enrollment: 54 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 3 patient groups

Home Exercise Only

Active Comparator group

Description:

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

Treatment:

Other: Adaptive Physical Activity

APA

Experimental group

Description:

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

Treatment:

Other: Adaptive Physical Activity

APA+TM

Experimental group

Description:

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.

Treatment:

Other: Adaptive Physical Activity