TAPAS: Testing Adaptive Physical Activity in Stroke

Sponsor

Baltimore VA Medical Center (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT01042990

Collaborator

University of Maryland (Other)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

"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:

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

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: Adaptive Physical Activity	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Testing Adaptive Physical Activity in Stroke

Study Start Date :

Sep 1, 2008

Anticipated Primary Completion Date :

Sep 1, 2011

Anticipated Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Other: Adaptive Physical Activity Structured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months
Experimental: APA Participants exercise in a gym setting 3x/week for six months, performing gait and balance exercises along with a progressive walking program.	Other: Adaptive Physical Activity Structured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months
Experimental: 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.	Other: Adaptive Physical Activity Structured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months

Arm

Intervention/Treatment

Active Comparator: 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.

Other: Adaptive Physical Activity

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

Experimental: APA

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

Other: Adaptive Physical Activity

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

Experimental: 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.

Other: Adaptive Physical Activity

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

Outcome Measures

Primary Outcome Measures

VO2 Peak [baseline, 3 months, 6 months, and 3 months post-intervention]
Berg Balance Scale [baseline, 3 months, 6 months, and 3 months post-intervention]
Dynamic Gait Index [Baseline, 3 months, 6 months, and 3 months post intervention]
Step Activity Monitoring [Baseline, 3 months, 6 months, and 3 months post-intervention]
6 Minute Walks [Baseline, 3 months, 6 months, and 3 months post-intervention]

Secondary Outcome Measures

Psychosocial questionnaires [baseline, 3 months, 6 months, and 3 months post-intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
Residual hemiparetic gait deficits.
Already completed all conventional inpatient and outpatient physical therapy.
Adequate language and neurocognitive function to participate in exercise testing and training (specific screening instruments used.)