Adaptive Physical Activity for Stroke: An Early-Stage Randomized Controlled Trial in the United States

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.

Keywords: community-based exercise program; exercise; rehabilitation; stroke.

Figure 1.

CONSORT (Consolidated Standards of Reporting Trials) flow diagram for the Adaptive Physical Activity (APA) study.

Figure 2.

Percentage of subjects in Adaptive Physical Activity (APA) and Sittercise completing numbers of exercise sessions. Maximum possible sessions attended equals 78.

Figure 3.

Mean 6-minute timed walk distances for Adaptive Physical Activity (APA) subjects (squares) and Sittercise subjects (circles) at baseline, 3 months, and 6 months. Filled symbols indicate all subjects, open symbols indicate subjects with dropouts excluded. Error bars indicate standard errors of the mean. Abbreviations: 6MWT, 6-minute timed walk test; SPPB, Short Physical Performance Battery; SIS, Stroke Impact Scale.