Protocol for the “four steps to control your fatigue (4-STEPS)” randomised controlled trial: A self-regulation based physical activity intervention for patients with unexplained chronic fatigue

摘要

Background: Unexplained Chronic Fatigue is a medical condition characterized by the presence of persistent,severe and debilitating medically unexplained fatigue, leading to impaired functioning and lower quality of life.Research suggests that physical activity can contribute to the reduction of fatigue and other somatic symptomsand can thus significantly improve physical functioning and quality of life in these patients. Based on the selfregulation(SR) theory of behaviour change, we developed a brief physical activity program for patients sufferingfrom unexplained chronic fatigue which focuses on the training of self-regulation skills, the “4-STEPS to controlyour fatigue” program.Methods/Design: This is a multi-centre, randomised controlled trial (RCT) that will be carried out in local primarycare centres and at the Portuguese Fibromyalgia and Chronic Fatigue Syndrome Patients Association. Patients agedbetween 18 and 65 and fulfilling operationalized criteria for Idiopathic Chronic Fatigue (ICF) and Chronic FatigueSyndrome (CFS) will be recruited and randomly allocated to standard care (SC) or standard care plus a selfregulationbased physical activity program (4-STEPS). Patients will be assessed at baseline, after the intervention (3months) and at 12 months follow-up. The primary outcome is fatigue severity.Discussion: The results of the RCT will provide information about the effectiveness of a brief self-regulationintervention for promoting physical activity in patients with unexplained chronic fatigue. If the program proves tobe effective, it may be considered as an adjunctive treatment for these patients.