Clinical trial NCT01042990: Testing Adaptive Physical Activity in Stroke
Official title: Testing Adaptive Physical Activity in Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
Exercise
Balance
Dynamic Gait
Cardiovascular Fitness
Lead sponsor: Baltimore VA Medical Center
Sponsor class: FED
Collaborators: name: University of Maryland
First posted: 2010-01-06
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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


Eligibility 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.)

Primary outcomes:
measure: VO2 Peak
timeFrame: baseline, 3 months, 6 months, and 3 months post-intervention
measure: Berg Balance Scale
timeFrame: baseline, 3 months, 6 months, and 3 months post-intervention
measure: Dynamic Gait Index
timeFrame: Baseline, 3 months, 6 months, and 3 months post intervention
measure: Step Activity Monitoring
timeFrame: Baseline, 3 months, 6 months, and 3 months post-intervention
measure: 6 Minute Walks
timeFrame: Baseline, 3 months, 6 months, and 3 months post-intervention
Secondary outcomes:
measure: Psychosocial questionnaires
timeFrame: baseline, 3 months, 6 months, and 3 months post-intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VAMC
state: Maryland
Study officials:
affiliation: University of Maryland
name: Richard F Macko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Kathleen M Michael, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Andrew P Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.