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Clinical Trial
. 2025 Jan 7;14(1):e034441.
doi: 10.1161/JAHA.124.034441. Epub 2024 Dec 24.

Fatigue After Stroke Educational Recovery Program: A Prospective, Phase III, Randomized Controlled Trial

Kelly Jones  1 , Rita Krishnamurthi  1 , Suzanne Barker-Collo  2 , Sulekha De Silva  1 , Nathan Henry  3 , Irene Zeng  3 , Anja Vorster  3 , Braden Te Ao  4 , Geoff Green  5 , Yogini Ratnasabapathy  6 , Valery Feigin  1
Affiliations
Clinical Trial

Fatigue After Stroke Educational Recovery Program: A Prospective, Phase III, Randomized Controlled Trial

Kelly Jones et al. J Am Heart Assoc. .

Abstract

Background: Poststroke fatigue affects ≈50% of patients with stroke, causing significant personal, societal, and economic burden. In the FASTER (Fatigue After Stroke Educational Recovery) study, we assessed a group-based educational intervention for poststroke fatigue.

Methods and results: Two hundred patients with clinically significant fatigue were included and randomized to either a general stroke education control or fatigue management group (FMG) intervention and assessed at baseline, 6 weeks, and 3 months. The FMG involved weekly psychoeducation sessions over 6 weeks. Coprimary outcomes were the Fatigue Severity Scale and Multidimensional Fatigue Inventory-20 total scores. Adjusted mean total Fatigue Severity Scale scores at 6 weeks (primary end point) were nearly identical for the education control and FMG groups. The adjusted mean difference between treatment groups was -0.13 (SE, 1.4; P=0.92) at 6 weeks and 1.67 (SE, 1.4; P=0.26) at 3 months. Although there were no significant effects, Fatigue Severity Scale outcomes were in the direction of a treatment effect based on the estimated change. Adjusted mean total Multidimensional Fatigue Inventory-20 scores at 6 weeks (primary end point) were similar for the education control and FMG groups. The adjusted mean difference between treatment groups was -0.91 (SE, 1.54; P=0.55) at 6 weeks and -1.26 (SE, 1.8; P=0.49) at 3 months. Both groups had similar secondary outcomes (eg, Multidimensional Fatigue Inventory-20 subscales, sleep, pain, mood, quality of life) at 6 weeks and 3 months.

Conclusions: We found no evidence of significant group-level benefits of FMG over and above general stroke education. Educational group-based interventions for poststroke fatigue should continue to be refined and examined, including consideration of potential impacts at an individual level.

Registration: URL: https://www.anzctr.org.au/; UnIque identifier: ACTRN12619000626167.

Keywords: education; fatigue; intervention; stroke.

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Figures

Figure 1
Figure 1. CONSORT 2010 flow diagram.
CONSORT indicates consolidated standards of reporting trials; EC, education controls; and FMG, fatigue management group.
Figure 2
Figure 2. Least squares mean plot of FSS at 6 weeks and 3 months.
Least squares means and their standard errors are presented. EC indicates education controls; FMG, fatigue management group; and FSS, Fatigue Severity Scale.
Figure 3
Figure 3. Least squares mean plot of MFI‐20 at 6 weeks and 3 months.
Least squares means and their standard errors are presented. EC indicates education controls; FMG, fatigue management group; and MFI‐20, Multidimensional Fatigue Inventory‐20.
See this image and copyright information in PMC

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