Abstract
Background
This study aimed at assessing the effects of a self-regulation-based brief physical activity program for patients suffering from unexplained chronic fatigue, the “4-STEPS to control your fatigue program”.
Method
A 12-week randomized controlled trial was conducted. Adult patients meeting the CDC criteria for idiopathic chronic fatigue were randomized to either the control condition (standard care) or the intervention condition (4-STEPS). The 4-STEPS was based on self-regulation principles and consisted of motivational interviewing and self-regulation skills training. All patients were assessed at baseline and post-treatment (12 weeks) for fatigue severity (primary outcome) and impact, physical activity (leisure time physical activity, number of daily steps and personal activity goal progress), health-related quality of life, somatic distress and psychological distress (depression and anxiety).
Results
Ninety-one patients (45 intervention and 46 control patients) received the allocated intervention. At post-treatment, statistical analysis revealed a significant difference for subjective experience of fatigue (4.73 points; g = 0.51) in favour of the intervention group. Mixed design ANCOVAs showed a significant effect of the 4-STEPS on fatigue severity, leisure time physical activity, personal activity goal progress and health-related quality of life. No significant effects were found for number of daily steps and somatic and psychological distress.
Conclusion
The 4-STEPS program has significant beneficial effects at post-treatment. This brief self-regulation-based intervention looks promising for the management of unexplained chronic fatigue.
Trial Registration: ISRCTN70763996
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Acknowledgments
This study was partially funded by the Portuguese Foundation for Science and Technology with a grant to the first author (SFRH/BD/47579/2008). The authors would like to thank all patients that participated in this research, the directors and medical doctors from the health-care centres (USF Conde de Oeiras, USF São Julião, USF Marginal, USF Navegantes, Medicil), the volunteers from MYOS, Andreia Cordeiro and Maria João Gouveia. We thank Keegan Knittle for his help with the revision of the manuscript.
Informed Consent
All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (Portuguese Medical-Ethics Committee of the Regional Health Administration guidelines) and with the Helsinki Declaration of 1975, as revised in 2000. Informed consent was obtained from all patients before being included in the study.
Conflict of Interest
Marta Marques, Véronique de Gucht, Isabel Leal and Stan Maes declare that they have no conflict of interest.
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Marques, M., De Gucht, V., Leal, I. et al. Effects of a Self-regulation Based Physical Activity Program (The “4-STEPS”) for Unexplained Chronic Fatigue: a Randomized Controlled Trial. Int.J. Behav. Med. 22, 187–196 (2015). https://doi.org/10.1007/s12529-014-9432-4
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DOI: https://doi.org/10.1007/s12529-014-9432-4