Effects of a self-regulation based physical activity program (the "4-STEPS") for unexplained chronic fatigue: a randomized controlled trial.

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.