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Randomized Controlled Trial
. 2024 Jan;55(1):5-13.
doi: 10.1161/STROKEAHA.123.044596. Epub 2023 Dec 22.

Increasing Activity After Stroke: A Randomized Controlled Trial of High-Intensity Walking and Step Activity Intervention

Affiliations
Randomized Controlled Trial

Increasing Activity After Stroke: A Randomized Controlled Trial of High-Intensity Walking and Step Activity Intervention

Elizabeth D Thompson et al. Stroke. 2024 Jan.

Abstract

Background: Physical inactivity in people with chronic stroke profoundly affects daily function and increases recurrent stroke risk and mortality, making physical activity improvements an important target of intervention. We compared the effects of a high-intensity walking intervention (FAST), a step activity monitoring behavioral intervention (SAM), or a combined intervention (FAST+SAM) on physical activity (ie, steps/day). We hypothesized the combined intervention would yield the greatest increase in steps/day.

Methods: This assessor-blinded multisite randomized controlled trial was conducted at 4 university/hospital-based laboratories. Participants were 21 to 85 years old, walking without physical assistance following a single, unilateral noncerebellar stroke of ≥6 months duration, and randomly assigned to FAST, SAM, or FAST+SAM for 12 weeks (2-3 sessions/week). FAST training consisted of walking-related activities at 70% to 80% heart rate reserve, while SAM received daily feedback and goal setting of walking activity (steps/day). Assessors and study statistician were masked to group assignment. The a priori-determined primary outcome and end point was a comparison of the change in steps/day between the 3 intervention groups from pre- to post-intervention. Adverse events were tracked after randomization. All randomized participants were included in the intent-to-treat analysis.

Results: Participants were enrolled from July 18, 2016, to November 16, 2021. Of 2385 participants initially screened, 250 participants were randomized (mean [SE] age, 63 [0.80] years; 116 females/134 males), with 89 assigned to FAST, 81 to SAM, and 80 to FAST+SAM. Steps/day significantly increased in both the SAM (mean [SE], 1542 [267; 95% CI, 1014-2069] P<0.001) and FAST+SAM group (1307 [280; 95% CI, 752-1861] P<0.001) but not in the FAST group (406 [238; 95% CI, -63 to 876] P=0.09). There were no deaths or serious study-related adverse events.

Conclusions: Only individuals with chronic stroke who completed a step activity monitoring behavioral intervention with skilled coaching and goal progression demonstrated improvements in physical activity (steps/day).

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02835313.

Keywords: exercise; goals; heart rate; stroke; walking.

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Conflict of interest statement

Disclosures Dr Hornby is the co-owner for the Institute for Knowledge Translation. Dr Kasner reports grants from Bayer Medtronic; consulting fees from Bristol Myers Squibb, DiaMedica, Medtronic, and WL Gore; and royalties from UpToDate. Dr Henderson is partially employed by the Institute for Knowledge Translation. The other authors report no conflicts.

Figures

Figure 1.
Figure 1.
CONSORT diagram. PT=physical therapy. CPET=cardiopulmonary exercise test.
Figure 2.
Figure 2.
Primary outcome: Change in steps/day by group. a) Steps/day mean values by group (error bars=standard error). b) Magnitude of steps/day change for each group (as mean(SE)). Inset shows both the mean(SE) by group and distribution of individual results.

Update of

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