Efficacy of a randomized controlled self-regulation based physical activity intervention for chronic fatigue: Mediation effects of physical activity progress and self-regulation skills
Introduction
Fatigue is a common symptom, usually transitory and explained by life circumstances, but for some, fatigue is medically unexplained and severe, resulting in disability and lower health-related quality of life [1], [2]. Unexplained fatigue is considered to be chronic if it lasts for at least 6 months (i.e. idiopathic chronic fatigue-ICF). If additional somatic symptoms as defined by the Centres for Disease Control and Prevention (CDC) are present, it is classified as Chronic Fatigue Syndrome (CFS) [3]. Guidelines for CFS management [1], [4], [5] recommend non-pharmacological treatments such as Graded Exercise Therapy (GET) or Cognitive Behavior Therapy (CBT), mainly because of the combination of psychological and behavioral factors that contribute to the perpetuation of chronic fatigue [1], [6], [7]. One of the main behavioral factors is prolonged physical inactivity (rest) and decreased physical capacity. It has been suggested that prolonged physical inactivity can result in physical deconditioning as well as in other physiological and psychosocial consequences that may perpetuate fatigue severity and disability [8], [9], [10]. At the same time, high levels of exercise can cause overexertion and perpetuate fatigue symptoms [11], [12].
GET is based on the assumption that aerobic exercise (e.g. brisk walking) or physical activity (e.g. housework, gardening) must be initiated at a level (intensity and frequency) that doesn't exacerbate symptoms and must be gradually increased until patients reach an optimal level of activity. GET follows the exercise prescription guidelines of the American College of Sports Medicine [13], tailored to each patient's initial level of physical capacity, and most interventions follow a similar protocol [14], [15]. GET has been shown to have beneficial effects on chronic fatigue management [16], [17], [18]. Because of the benefits of physical activity in patients suffering from ICF/CFS, many Cognitive Behavioral Therapy (CBT) trials have also incorporated a graded exercise component. Despite some beneficial effects of both GET and CBT on ICF/CFS patients, effects of these trials are heterogeneous [16], [17], and present limited effects upon physical capacity and daily activity [17]. One explanation for the differences in the effectiveness may be that some interventions result in creating cognitive or behavioral changes that may mediate the effect of the intervention on fatigue, while others do not result in such changes. Available research on the mechanisms of treatment effects in the context of CFS, has found evidence for the prospective mediating role of cognitive factors, mainly fear avoidance beliefs (e.g. [19], [20], [21]), avoidance behavior, and catastrophizing [19], [21]. Regarding behavioral mediators, such as physical activity, while a secondary mediation analysis of the PACE trial found a mediation effect of timed walking distance in a GET treatment [21], the study by Wiborg and colleagues [22] analysing the mediation effect of PA on fatigue severity and including data from two CBT trials targeting PA in CFS adult patients [23], [24], did not find a significant mediation effect. However, none of the trials included in the analysis had a significant impact on PA levels. In the present article we will therefore not only report on the medium-term effects of a self-regulation physical activity based program for ICF/CFS patients, but we will also explore possible mediators of these effects in the context of a self-regulation based intervention, more specifically physical activity related variables, and self-regulation skills.
Adopting a health behavior change framework can contribute to the understanding and promotion of physical activity in chronic fatigue patients. Recent studies have shown that self-regulation (SR) based interventions are effective in promoting long-lasting health behavior change in patients suffering from various chronic diseases (e.g. [25], [26]). SR can be defined as a “sequence of actions and/or steering processes intended to attain a personal goal” [27]. Central in self-regulation theories (e.g. Control Theory, [28]) is the assumption that human actions are goal-oriented and that self-regulation processes (e.g. skills) guide the achievement of personally relevant goals [27], [28]. Thus, health behavior change is a dynamic goal-guidance process consisting of a goal selection and setting phase, active goal pursuit and goal attainment phase, in which motivational and volitional aspects interact [27]. Personal goal setting, a central aspect in SR theory, is a first step and implies that formulating self-chosen and personally important goals guide behavior change and increase the likelihood of goal achievement and maintenance [27], [29]. As a consequence, SR models may also encourage patients to change their personal goals from symptom avoidance to more active and positive goals [30].
Motivational interviewing (MI), a “collaborative conversation style for strengthening a person's own motivation and commitment to change” ( [31] p. 12) is frequently used to evoke and strengthen patients own motivation and confidence to change, and to support patients in setting personal health-related goals by increasing the personal relevance of health goals. MI is considered especially helpful in helping patients move from ambivalence towards behavior change. While MI mainly focuses on SR cognitions, SR skills play an important part not only in the formulation of health-related goals (e.g. physical activity) but also during active goal pursuit and during the maintenance phase of the behavioral change process [27]. In a meta-analysis, Michie et al. [32] found that interventions combining self-monitoring with other skills derived from self-regulation theory, such as goal setting, provision of feedback, planning and goal reformulation, were more effective in promoting changes in PA and healthy eating in the general population than other interventions not using these techniques. Moderation effects of SR-skills on effects in relevant outcomes were also found in other meta-analyses of trials conducted with chronic patients [33], [34], [35].
Based on the SR approach described above, we developed a brief intervention targeting physical activity for patients with ICF/CFS (the “4-STEPS to control your fatigue” program) [36]. The 4-STEPS is a brief intervention, requiring minimal contact with participants. Recent minimal direct contact trials have shown promising results [23], [37]. In this program participants set their own physical activity goals and are advised to gradually increase their physical activity levels according to a specific personal scheme [11], allowing for flexibility in the intensity and duration of exercise according to symptom fluctuation, without exceeding one's own capacity.
The 4-STEPS program was tested in a randomized controlled trial [38], in which patients were either assigned to the control group (usual care) or to a 12-week self-regulation intervention (4-STEPS program). Post-treatment beneficial effects of the 4-STEPS program were found for fatigue severity, health-related quality of life (physical and psychological components), leisure-time physical activity and perceived physical activity goal progress. No effects were found for fatigue impact on daily life, daily steps, somatic distress, and psychological distress (depression and anxiety).
The first objective of the present study is to examine the sustained effects of the 4-STEPS over time, reporting on the 12-months follow-up results of the 4-STEPS intervention on fatigue severity and impact on daily life, physical activity, health-related quality of life, somatic distress and psychological distress. The second objective is to examine the mediators of intervention effects on the subjective experience of fatigue. It is hypothesized that the intervention increases the intermediate targets of our intervention – physical activity and the use of self-regulation skills -, and that this increase mediates the medium-term effects of the intervention on fatigue improvement (Appendix A).
Section snippets
Trial design
This study concerns the follow-up results of a randomized controlled trial that has been previously described in full detail, including the intervention and measures description [36], [38]. It was a two-arm 12-week parallel multicentre randomized controlled trial. Randomisation was stratified by sample (from Health care centres and Patient Association), with equal randomisation (1:1) to either the intervention condition or the control condition. Allocation sequence was based on
Participant flow and patient characteristics
The flow of patients through the trial and reasons for exclusions and withdrawals are shown in Fig. 1. A total of 165 individuals were identified as eligible to participate and were informed about the study. Of these, 91 patients randomly allocated to either the 4-STEPS program or the control condition completed baseline assessment and received allocated treatment (n = 45 and n = 46, respectively). Sixteen (35%) participants in the intervention group and fifteen (32%) participants in the control
Discussion
This trial tested the 12-months follow-up effects of a brief self-regulation (SR) based intervention for patients with unexplained chronic fatigue (4-STEPS), which combined face-to-face motivational interviewing with SR skills training. Post-treatment (3-months) results showed beneficial effects of the 4-STEPS on subjective experience of fatigue (primary outcome) and total fatigue severity [38]. At 12-months follow-up, these beneficial effects were maintained and a larger difference was found
Conclusion
Despite its limitations, this study found that a brief intervention has sustained effects in fatigue management. Minimal direct contact interventions that can be easily implemented in standard health care can be useful for people diagnosed with ICF/CFS presenting difficulties in attending regular health care facilities [61] and/or for those who do not need more intensive forms of treatments [37]. Furthermore, our results suggest that using motivational and self-regulation principles and
Author(s) statement of conflict of interest and adherence to ethical standards
Marta Marques, Véronique de Gucht, Isabel Leal and Stan Maes, declare that they have no conflict of interest. Marta Marques has received a research grant from the Portuguese Foundation for Science and Technology (SFRH/BD/47579/2008). All procedures, including the informed consent process, were done in accordance with the ethical standards of the responsible committee on human experimentation (Portuguese Medical-Ethics Committe of the Regional Health Administration guidelines) and with the
Acknowledgement
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, Maria José Vazão, and Andreia Cordeiro.
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