Managing fatigue in Parkinson's disease: Preparing for a randomized controlled trial

Background Fatigue in Parkinson's disease (PD) is a common, debilitating symptom often overlooked in research and clinical practice. Effective interventions are needed to mitigate its impact on people with PD. Objective This pilot study evaluated the feasibility of the individual videoconference version of the Packer Managing Fatigue program for people with PD and explored its preliminary effectiveness versus usual care to inform the design of a definitive trial. Here we report on the second objective. Methods A two-arm, assessor-masked, randomized controlled pilot study recruited participants with PD who experience severe fatigue, have English proficiency, and internet access. Outcome measures included occupational performance, satisfaction with performance, occupational balance, fatigue impact, quality of life, and sleep. Mixed repeated-measures ANOVA and non-parametric tests were used for analysis. Results Mixed-design ANOVA (N = 25) showed an exploratory trend toward significant for the Time × Group interaction effect differences in satisfaction with performance between groups over time ( p = 0.09). Paired t-tests within the intervention group indicated significant improvement in satisfaction with performance ( p = 0.04). The effect size for this outcome was moderate. Small to moderate effect sizes were observed for occupational balance, occupational performance, and subscales of the Multidimensional Fatigue Inventory. Other measures showed negligible effects. Conclusions The results provide preliminary evidence of the program's benefits for people with PD. Larger, more rigorous studies are needed to confirm its effectiveness. Despite the small sample size and challenges posed by COVID-19, this study offers valuable insights into recruitment strategies and effect sizes to inform future trial designs.