Abstract
Background.
As stroke survival improves, there is an increasing need for effective,
low-cost programs to reduce deconditioning and improve mobility.
Objective.
To conduct a phase II trial examining whether the community-based
Italian Adaptive Physical Activity exercise program for stroke survivors
(APA-Stroke) is safe, effective, and feasible in the United States.
Methods.
In this single-blind, randomized controlled trial, 76 stroke survivors
with mild to moderate hemiparesis >6 months were randomized to either
APA-Stroke (N = 43) or Sittercise (N = 33). APA-Stroke is a progressive
group exercise regimen tailored to hemiparesis that includes walking,
strength, and balance training. Sittercise, a seated, nonprogressive
aerobic upper body general exercise program, served as the control. Both
interventions were 1 hour, 3 times weekly, in 5 community locations,
supervised by exercise instructors.
Results. A total of 76
participants aged 63.9 ± 1.2 years, mean months poststroke 61.8 ± 9.3,
were included. There were no serious adverse events; completion rates
were 58% for APA-Stroke, 70% for Sittercise. APA-Stroke participants
improved significantly in walking speed. Sample size was inadequate to
demonstrate significant between-group differences. Financial and
logistical feasibility of the program has been demonstrated. Ongoing APA
classes have been offered to >200 participants in county Senior
Centers since study completion.
Conclusion. APA-Stroke shows
great promise as a low-cost, feasible intervention. It significantly
increased walking speed. Safety and feasibility in the US context are
demonstrated. A pivotal clinical trial is required to determine whether
APA-Stroke should be considered standard of care.
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