Effects Of A Self-regulation Based Physical Activity Program (The “4-STEPS”) For Unexplained Chronic Fatigue: A Randomized Controlled Trial

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 in the subjective experience of fatigue (4.73 points; g=0.51) in favor 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 a number of daily steps and somatic and psychological distress. 

Conclusion The 4-STEPS program has significant beneficial effects post-treatment. This brief self-regulation-based intervention looks promising for the management of unexplained chronic fatigue. Trial Registration: ISRCTN70763996 

Keywords Chronic fatigue. A randomized controlled trial. Physical activity. Self-regulation 

Introduction

Unexplained or idiopathic chronic fatigue (ICF) is a condition characterized by the presence of severe and persistent fatigue (lasting for at least 6 months) that cannot be explained by an organic disease. According to the Centres for Disease Control and Prevention (CDC), persistent fatigue is diagnosed as chronic fatigue syndrome (CFS), a condition that a minimum number of additional somatic symptoms are present [1]. CFS is a serious medical condition in which the patient’s functioning is significantly impaired leading to disability and lower health-related quality of life (HRQoL) [2]. One of the major symptoms is the presence of post-exertional malaise, which is characterized by severe exhaustion following physical activity. Patients’ perceptions and expectations related to symptom exacerbation as a consequence of exercise can lead to fear of physical exercise and can, therefore, explain the reduced levels of physical activity found in these patients [3, 4]. In addition, several studies emphasize the fact that the lack of physical activity and excessive resting found in these patients can result in physical deconditioning and, as a consequence, perpetuate fatigue severity and physical disability [4–6]. Therefore, (balanced) physical activity has been considered to be an important behavior in managing chronic fatigue [7]. Graded exercise therapy (GET), a behavioral intervention targeting a gradual increase in aerobic exercise (in order to avoid overexertion), has been shown to have beneficial effects.

on fatigue severity in CFS patients [8]. Cognitive behavioral therapy (CBT), which usually incorporates changes in physical activity (and rest) behavior, has also been demonstrated to be effective in reducing fatigue symptoms in CFS patients [9]. A recent meta-analysis compared the effectiveness of getting and CBT [10]. Both were moderately effective in reducing fatigue and functional impairment. Still, the results were heterogeneous. Both CBT and GET interventions are usually resourced intensive requiring a considerable number of contact hours and sessions (in general between 8 and 16 sessions) with patients [10, 11]. Recently, two randomized controlled trials that tried to overcome this limitation by conducting minimal contact CBT interventions based on self-guided instruction manuals and regular email contacts showed promising results [12, 13]. Another intervention study (pragmatic rehabilitation) targeting physical activity for chronic fatigue patients, comparing treatment conditions that differ in intensity, found that the minimum intervention conditions (two face-to-face sessions with or without seven brief telephone contacts) were as successful as a more extensive version of the program (nine face-to-face sessions) [14]. Adopting a health behavior change framework, such as self-regulation (SR) theory, e.g. [15] can be useful for promoting physical activity in chronic fatigue patients [16, 17]. SR-based interventions have been demonstrated to be effective in promoting health behavior change in chronic disease populations [17–20]. According to SR theory, behavior is a goal guidance process [16]. This process consists of a goal selection/goal setting or motivational phase, an active goal pursuit or action phase and a goal attainment or maintenance phase. Several SR cognitions and skills are guiding this process, such as autonomous regulation of behavior (and goal ownership), self-efficacy, goal setting, planning, self-monitoring, feedback, emotional and attention regulation and relapse prevention strategies [16]. An important form of intervention that incorporates SR principles is motivational interviewing (MI), which is a “collaborative conversation style for strengthening a person’s own motivation and commitment to change” ([21] p. 12). In MI, the patient’s own motivation for change is evoked and self-efficacy is strengthened. MI was found to be effective in promoting health behavior change, especially in helping patients move from ambivalence toward behavior change during a motivational phase [21, 22]. While MI mainly focuses on SR cognitions, SR skills are equally important, especially during the active goal pursuit and maintenance phase [16]. From this perspective, we developed a brief SR-based intervention, combining MI and SR skills training to target physical activity among patients with unexplained chronic fatigue (the “4-STEPS to control your fatigue” program). This study aimed at evaluating the effects of the 4-STEPS program on fatigue severity and impact, physical activity, health-related quality of life, somatic distress, and psychological distress.

BUY Anti-Fatigue Cistanche for Relive CFS

Method

The rationale and details of the trial design were given in detail elsewhere [23] and will thus only be briefly summarized here. Trial Design

This was a 12-week parallel-group, multicentre randomized controlled trial, with equal randomization (1:1) to either the intervention condition (4-STEPS program) or the control condition. The randomization sequence was stratified by sample (health-care centers and patient association) and within the first sample also by the center. Randomization was conducted using computer-generated allocation numbers under the supervision of a member of the research team, who did not take part in the subsequent phases of the trial. Group allocation was known to subjects, therapists,s, and assessors. Patients were recruited from consecutive referrals. Patients were assessed at baseline (T1) and 12 weeks later (post-treatment, T2). The primary outcome was a subjective experience of fatigue, and secondary outcomes were fatigue severity, fatigue impact, physical activity, HRQoL (physical and psychological functioning), somatic distress, and psychological distress (depression and anxiety). Approval was obtained from the Portuguese Medical Ethics Committee of the North Regional Health Administration and from the medical board of each participating healthcare center. The trial was conducted between January 2011 and December 2012. 

Participants and Procedure

Adult patients meeting the CDC criteria for idiopathic chronic fatigue (i.e. presenting the main complaint of unexplained fatigue of at least 6 months duration) were eligible to participate in the study [1]. Additional inclusion criteria were to fully understand and speak Portuguese and to have the capacity to provide informed consent. Patients presenting a concurrent somatic condition and/or a severe psychiatric disorder that could explain fatigue symptoms (according to the CDC criteria for exclusionary medical and psychiatric conditions [1]) were excluded. The study was conducted in several Portuguese healthcare institutions (four public primary care centers and one private practice) and in the Portuguese Fibromyalgia and Chronic Fatigue Syndrome Patient Association. Based on the inclusion and exclusion criteria, patients from the healthcare centers were referred by their medical doctors. All patients were informed of the trial content and invited for an individual interview in the healthcare center (baseline assessment). Patients from the patient association who met the criteria (i.e. clinical diagnosis of unexplained chronic fatigue) and previously indicated their willingness to participate in research received an institutional letter containing the details of the trial. Patients who wished to participate returned the written informed consent form and were invited for the baseline assessment. For both samples, the inclusion and exclusion criteria were checked by the research team using self-report measures based on the CDC criteria. In addition to standard medical care, patients assigned to the control condition received a flyer with information about the general health benefits of physical activity and current physical activity guidelines for adults [24] and set a personal physical activity goal for the upcoming months. Participants assigned to the intervention condition additionally received the 4-STEPS program.

4-STEPS to Control Your Fatigue

The 4-STEPS program consisted of a brief SR-based intervention to promote physical activity in chronic fatigue patients. The intervention was delivered by one trained health psychologist (with motivational interviewing training) to individual patients. The intervention was structured around the SR phases of goal pursuit (goal selection and setting, active goal pursuit and goal attainment, maintenance, and disengagement) [17]. Firstly, participants received two 1-h face-to-face individual motivational interviewing sessions (weeks 1 and 3) aimed at (a) exploring important health and life goals to which a physical activity goal could be related, (b) increasing participants’ motivation and confidence to be physically active and (c) setting a specific personal physical activity goal. This personal and flexible physical activity goal, which took into consideration the need to avoid overexertion, was set by each patient during the second MI session. Patients also formed action plans regarding their goals (i.e. which physical activities would be done and when, where, for how long, and with whom each would take place). Secondly, participants received an informational booklet (available from the first author) containing information regarding (a) the diagnosis of CF(S), (b) factors contributing to a better or worse prognosis, and (c) the link between CF(S) symptoms and physical (in-)activity and the boom-bust pattern (i.e. erratic pattern of rest and activity) commonly found in these patients. Thirdly, an SR-based workbook (available from the first author) was given to patients. The SR workbook was divided into four steps, each one focusing on specific SR cognitions and skills: step 1—“Am I ready to start?” (focusing on self-efficacy, motivation, and control over competing goals), step 2—“My physical activity goal” (focusing on goal setting, action planning, and self-monitoring), step 3—“Overcoming obstacles” (focusing on coping efficacy and planning, feedback and attention and emotion regulation, i.e. control of distracting stimuli and negative emotions to maintain a focus on goal pursuit) and step 4—“I am physically active…and I want to keep it this way” (focusing on relapse prevention, including coping efficacy and planning and goal reformulation). Fourthly, patients received two brief SR-based telephone counseling sessions (weeks 5 and 9). This telephone support aimed at reviewing the participants’ physical activity goals and providing relapse prevention strategies. Fifthly, patients received a pedometer to register steps taken on a daily basis during the 12-week intervention period. Finally, patients received a leaflet for their partner or significant other with relevant information on chronic fatigue, the objective of which was to increase social support.

Outcomes

Patient Characteristics Socio-demographic characteristics included age, gender, education, and employment status. Clinical information was gathered using the following indicators: (1) presence of persistent fatigue, (2) duration of fatigue symptoms, (3) impact of fatigue on daily activities (4) whether fatigue was alleviated by rest, (5) number of medical consultations and (6) a CDC-based symptom checklist for CFS [25]. The checklist presents 19 major and minor symptoms of CFS, as defined by the CDC criteria [1]. Respondents are asked to rate if they experienced each of the symptoms for the last 6 months. For the purpose of this study, a dichotomous scale (yes/no) was used. A major symptom score is calculated by adding up the number of major symptoms presented (ranging from 1 to 8). To be diagnosed with CFS, patients need to have a complaint of persistent unexplained fatigue (at least 6 months) that leads to a significant disability and to have at least four of the major CFS symptoms listed by the CDC. Patients not fulfilling the full criteria were classified as ICF patients. The self-reported measures also included a question regarding the presence of chronic disease and/or psychiatric disease, as well as name and duration if any.

Fatigue Severity It was assessed at T1 and T2 by means of the Portuguese adaptation of the Checklist of Individual Strength (CIS20-P) [26], which is a well-validated and reliable measure for assessing fatigue severity in chronic fatigue patients [27]. The CIS20 is a 20-item self-report measure that assesses four dimensions of fatigue: the subjective experience of fatigue, concentration, motivation, and activities. Items are rated on a seven-point scale. A total score (total fatigue severity) can be calculated by adding up the scores for each dimension. For the purpose of this study, only the subjective experience of fatigue dimension (primary outcome; range 8–56) and the total fatigue severity score (range 20–140) were used. Higher scores indicate more fatigue. A cutoff point of 35 on the subjective experience of fatigue dimension of the CIS20 is usually used to define a clinical level of fatigue [28]. 

Fatigue Impact It (T1 and T2) was measured by means of a modified version of the pain interference dimension of the well-validated Brief Pain Inventory (BPI) consisting of seven items [29]. Participants were asked to rate on a 10- point scale how their fatigue interfered with several aspects of their life. The total score was used as an outcome. Higher scores indicate a higher fatigue impact (ranging from 0 to 10).

Discussion

This study examined the effect of 12-week brief self-regulation (SR)-based program for unexplained chronic fatigue (4-STEPS) targeting physical activity. Attrition to the trial was higher than initially anticipated (≥20 %), but this study included a larger sample than what was established in the study protocol [23]. At post-treatment, there was a significant beneficial effect of the 4-STEPS program on the subjective experience of fatigue (primary outcome). Although the difference between the intervention and control conditions did not reach the seven-point target, the significant decrease in the subjective experience of fatigue in the intervention group (3.38) can be considered to be clinically significant as the difference exceeds 0.5 SD, a criterion used in other GET and CBT trials [42, 43]. A mixed design analysis comparing the intervention and control conditions at T1 and T2 revealed a moderate beneficial effect of the 4-STEPS program on the subjective experience of fatigue and total fatigue severity (g=0.44, g=0.39). These results are in line with the average effect size for fatigue severity found in a previous meta-analysis of graded exercise and psychological interventions for chronic fatigue management (g=0.41 and g=0.36) [10]. These effects are however lower than those found in other psychological-based minimal interventions [12, 15]. 

BUY Anti-Fatigue Cistanche Energy Pills for Relive CFS

No significant differences were found between the proportion of patients in each condition who reached non-clinical levels of fatigue (<35) at T2; however, the number of patients presenting non-clinical levels of fatigue in the intervention condition is comparable to what is reported in other trials [12, 13]. Furthermore, we found an increase in the number of patients in the intervention group presenting non-clinical levels of fatigue compared to baseline. Beneficial effects were also found for leisure time physical activity (g= 0.77), resulting in a significantly higher number of active patients in the intervention group at T2. We observed a small increase in the daily number of steps in the intervention group (e 450 steps) as compared to a reduction in the daily steps in the control group, but time-by-group interaction was not statistically significant. Current guidelines of physical activity for individuals with chronic disease recommend a minimum of 6500–8500 steps a day, which was achieved by the intervention group at post-treatment. Still, the average increase in the number of steps in pedometer-based interventions is about 2215 steps/day (or an effect size of 0.67), which is considerably higher than those obtained in our trial [44]. Earlier trials have found small to medium effects of exercise interventions on the levels of physical activity/capacity in chronic fatigue patients [42, 45]. 

Other studies did not find these beneficial effects [12, 46]. However, these studies measured physical activity in a different way, mainly in a laboratory setting making use of functional capacity measures, e.g. [46], walking tests [42] or actigraphy [12]. In addition, a large effect (g=0.83) of the 4- STEPS program was found on patients' progress in the attainment of their personal physical activity goals. This result points to the important role of self-regulation cognitions and skills in self-set health behavior goal pursuit. In addition, patients who received the 4-STEPS program showed a significant improvement in physical health-related quality of life (HrQoL; g=0.41). This effect is in line with the average effect size for functional impairment found in a previous meta-analysis (g=0.38) [10]. Furthermore, we found a significant effect of small magnitude for psychological HrQoL (p=0.47, g=0.33). These results point to the psychological deterioration and increasing disability resulting from the burden of a prolonged chronic condition. Likewise, no significant beneficial effects were found for psychological distress (depression and anxiety). This last result is in line with previous studies including CBT trials [10]. Because of contradictory findings of physical exercise programs in CF(S), it has been suggested recently that physical activity programs should incorporate flexible goals that take into consideration symptom fluctuation and rest [47]. In the present study, goals related to physical activities were personal and planned according to these principles. In addition, the findings of the present study support minimal contact interventions using manuals. As such, this theory-based brief intervention, using motivational interviewing principles and self-regulation skills training, encouraged patients to set self-chosen active and positive goals and provided them with the skills to put them into practice [16, 48]. In spite of its strengths, the present study also has some limitations. First, the small sample size limits the generalizability of the findings. Likewise, the lack of significance found for some of the secondary outcomes may be due to low statistical power, as our study was not powered to detect changes in secondary outcomes. Second, this trial was carried out in healthcare centers and inpatient associations. To deal with potential bias, the randomization procedure was stratified by sample, and repeated measure analyses were conducted controlling for the setting (health-care centers vs. patient association). Differences in the recruitment strategy within these settings may have led to a selection bias. Furthermore, the findings may also be biased by self-selection due to the high rate of patients not interested in participating in the trial. It may be that patients willing to participate were more motivated to change than non-participants.

Third, confirmation of CF(S) inclusion and exclusion criteria were based on self-reports according to the CDC criteria, and it can therefore not be excluded that some patients did not fulfill all the criteria. Ideally, this diagnosis should also rule out other somatic and psychiatric causes of the symptoms by means of a full clinical assessment and standardized psychiatric interview. Fourth, allocation of participants to the conditions was conducted prior to baseline assessments as the goal elicitation procedure took place at different moments for each condition (baseline assessment for the control group and at the second face-to-face session for the intervention group). This constitutes an additional potential source of bias. Fifth, the intervention was delivered by only one psychologist, which did not allow controlling for therapist effects in our analysis. Furthermore, due to resource constraints, we could not assess treatment integrity, which is an important procedure to enhance the validity of interventions. Sixth, men were largely underrepresented in the sample, and as a consequence, more studies are needed to determine the effectiveness of this program in men suffering from CF(S). Seventh, due to the fact that there are no normative data for the Portuguese CIS20, comparisons made regarding (non-)clinical levels of fatigue severity should be interpreted with care. Finally, this intervention combined motivational interviewing, several self-regulation techniques and motivational tools (e.g. pedometer), and the effect of these components cannot be separated. Future studies could address this issue by using a full-factorial design. In summary, this study shows that a brief SR intervention targeting (balanced) physical activity has significant post-treatment beneficial effects on fatigue severity, physical activity, personal goal progress related to physical activity, and health-related quality of life in chronic fatigue patients. This low-resource intervention looks promising for the management of chronic fatigue. A follow-up assessment (12 months) will provide the necessary information to evaluate the medium-term effects of the 4-STEPS program.

If you have any questions, please send us an Email: wallence.suen@wecistanche.com