M Marques1, V De Gucht, I Leal, S Maes. 1. Health and Medical Psychology Unit, Leiden university, Wassenaarseweg 52, P.O. BOX 955, 2300 RB, Leiden, The Netherlands, mmarques@ispa.pt.
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.
RCT Entities:
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.
Authors: Joanna Leaviss; Sarah Davis; Shijie Ren; Jean Hamilton; Alison Scope; Andrew Booth; Anthea Sutton; Glenys Parry; Marta Buszewicz; Rona Moss-Morris; Peter White Journal: Health Technol Assess Date: 2020-09 Impact factor: 4.014