FASTER
Trial question
What is the role of fatigue management group intervention in patients with post-stroke fatigue?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 200
200 patients (87 female, 113 male).
Inclusion criteria: patients with clinically significant post-stroke fatigue.
Key exclusion criteria: pre=stroke fatigue; significant disability; cognitive/behavioral impairments or a medical condition precluding participation; other causes of fatigue.
Interventions
N=100 fatigue management group (6 weekly, 60-90 minutes, sessions of fatigue, fatigue management, sleep/relaxation, exercise and nutrition, mood and future strategy use).
N=100 general stroke education (a single group session focused on stroke and related topics with minimal focus on fatigue).
Primary outcome
Mean total Fatigue Severity Scale scores at 6 weeks
40.9 points
40.8 points
40.9 points
30.7 points
20.4 points
10.2 points
0.0 points
Fatigue management
group
General stroke
education
No significant
difference ↔
No significant difference in mean total Fatigue Severity Scale scores at 6 weeks (40.9 points vs. 40.8 points; MD 0.13, 95% CI -2.67 to 2.93).
Secondary outcomes
No significant difference in mean total Multidimensional Fatigue Inventory-20 scores at 6 weeks (56.9 points vs. 55.9 points; AD 0.91 points, 95% CI -2.12 to 3.95).
No significant difference in mean sleep quality at 6 weeks (6.4 points vs. 7.1 points; MD -0.7, 95% CI -1.6 to 0.3).
No significant difference in mean anxiety at 6 weeks (4.2 points vs. 4 points; MD 0.2, 95% CI -0.5 to 1).
Safety outcomes
No significant difference in death and adverse events.
Conclusion
In patients with clinically significant post-stroke fatigue, fatigue management group was not superior to general stroke education with respect to mean total Fatigue Severity Scale scores at 6 weeks.
Reference
Kelly Jones, Rita Krishnamurthi, Suzanne Barker-Collo et al. Fatigue After Stroke Educational Recovery Program: A Prospective, Phase III, Randomized Controlled Trial. J Am Heart Assoc. 2025 Jan 7;14(1):e034441.
Open reference URL