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Randomized Controlled Trial
. 2020 May 18;9(10):e015377.
doi: 10.1161/JAHA.119.015377. Epub 2020 May 12.

Randomized Trial of Combined Aerobic, Resistance, and Cognitive Training to Improve Recovery From Stroke: Feasibility and Safety

Sebastian Koch  1 , Eduard Tiozzo  2 , Marialaura Simonetto  1 , David Loewenstein  2 , Clinton B Wright  3 , Chuanhui Dong  1 , Antonio Bustillo  1 , Miguel Perez-Pinzon  1 , Kunjan R Dave  1 , Carolina M Gutierrez  1 , John E Lewis  2 , Marti Flothmann  1   4 , M Carolina Mendoza-Puccini  3 , Barbara Junco  1 , Zuzel Rodriguez  1 , Joyce Gomes-Osman  2   4 , Tatjana Rundek  1   4 , Ralph L Sacco  1   4
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Randomized Controlled Trial

Randomized Trial of Combined Aerobic, Resistance, and Cognitive Training to Improve Recovery From Stroke: Feasibility and Safety

Sebastian Koch et al. J Am Heart Assoc. .

Abstract

Background Physical exercise and cognitive training have been recommended to improve cognitive outcomes poststroke, but a multifaceted strategy including aerobic, resistance, and cognitive training to facilitate poststroke recovery has not been investigated. We aimed to assess the feasibility, adherence, and safety of a combined aerobic, resistance, and cognitive training intervention (CARET+CTI) after stroke. Methods and Results We prospectively randomized patients presenting with recent stroke to a comparison of a supervised 12-week CARET+CTI program and a control group receiving sham CARET+CTI. Participants were scheduled for 3 weekly CARET and CTI sessions. All participants underwent pre- and postintervention assessments of strength, endurance, and cognition. The primary outcomes were feasibility and adherence, defined as the ratio of scheduled and observed visits, and safety. We enrolled 131 participants, of whom 37 withdrew from the study. There were 17 (20%) withdrawals in the CARET+CTI and 20 (44%) in the control group. The observed-over-expected visit ratio was significantly higher in the intervention than in the control group (0.74±0.30 versus 0.54±0.38; P=0.003). A total of 99 adverse events were reported by 59 participants, none of which were serious and related to the intervention. Greater gains in physical, cognitive, and mood outcomes were found in the CARET+CTI group than in the control group, but were not statistically significant after adjustments. Conclusions A CARET+CTI intervention, after stroke, is safe, feasible, and has satisfactory participant adherence over 12 weeks. REGISTRATION URL: https://www.clini​caltr​ials.gov. Unique identifier: NCT02272426.

Keywords: cognitive training; exercise; randomized clinical trial; stroke recovery.

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Figures

Figure 1
Figure 1
A, Kaplan‐Meier curves demonstrating earlier and more frequent withdrawals in the control group and (B) reasons for withdrawing.
See this image and copyright information in PMC

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