Efficacy of randomized controlled brief physical activity self-regulation for chronic fatigue

[Dolphin]

Full title: Efficacy of a randomized controlled brief physical activity self-regulation intervention for chronic fatigue: Mediation effects of physical activity progress and self-regulation skills

http://www.jpsychores.com/article/S0022-3999(16)30635-3/abstract

Efficacy of a randomized controlled brief physical activity self-regulation intervention for chronic fatigue: Mediation effects of physical activity progress and self-regulation skills

Affiliations

• Interdisciplinary Centre for the Study of Human Performance (CIPER), Faculty of Human Kinetics, University of Lisbon, Portugal

• Leiden University, Department of Health, Medical and Neuropsychology, PO Box 9555, 2300 RB Leiden, The Netherlands

Correspondence

• Corresponding author at: Estrada da Costa, 1495-002 Cruz Quebrada, Portugal .

Affiliations

• Interdisciplinary Centre for the Study of Human Performance (CIPER), Faculty of Human Kinetics, University of Lisbon, Portugal

• Leiden University, Department of Health, Medical and Neuropsychology, PO Box 9555, 2300 RB Leiden, The Netherlands

Highlights

• •4-STEPS yielded sustained small to moderate sustained effects on self-reported fatigue severity, impact, and health-related quality of life.
• •There were modest effects on physical activity. There were no significant effects on psychological and somatic distress.
• •Benefits on fatigue severity at 12 months were partially explained by physical activity goal progress.

Abstract
Objective
Examine the medium-term effects of a brief physical activity (PA) self-regulation (SR) based intervention (4-STEPS program) for chronic fatigue, and explore the mediating effects of PA related variables and SR skills.

Methods
A two-arm randomized controlled trial (Usual Care vs 4-STEPS) was carried out. The 4-STEPS program consisted of Motivational Interviewing and SR-skills training. Fatigue severity (primary outcome) and impact, PA, health-related quality of life (HrQoL), and somatic and psychological distress were assessed at baseline, post-treatment (12 weeks) and 12 months follow-up.

Results
Ninety-one patients (45 intervention and 46 controls) were included. At follow-up, there were significant treatment effects on fatigue severity (g = 0.72) and fatigue impact, leisure-time PA, and physical and psychological HrQoL. No significant effects were found for number of daily steps and somatic and psychological distress. Fatigue severity at follow-up was partially mediated by post-treatment progress on a personal PA goal (effect ratio = 18%).

Conclusion
Results suggest that a brief intervention, focusing on the formulation and pursuit of personal PA goals and the use of SR skills, produces sustained benefits for fatigue severity. Despite these promising results, dropout was high and the intervention was not beneficial for all secondary outcomes.

 

[Dolphin]

Although this is described as a trial of chronic fatigue, 89% in the intervention group and 94% in the control group had CFS (Fukuda criteria).

 

[Dolphin]

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.

This sounds more flexible than some graded activity/exercise regimes.

 

[Dolphin]

This paper is on the 12 month follow-up results. Here is what how they summarise the results from the original trial:

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 selfregulation 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).

 

[Dolphin]

PA=Physical Activity

Since physical activity is a key target in many interventions designed for people with CFS, it is important to analyse if changes in PA actually lead to improved fatigue. In the present study, we conducted a mediation analysis to test if the effect of treatment on subjective fatigue severity at follow-up could be explained by physical activity related variables. Results showed that an increased number of daily steps did not mediate treatment effects on fatigue. This result is in line with 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]. At the same time, we did find that personal goal progress partially explained the effects of treatment on sustained fatigue improvement. In addition, a recent study on CFS found that perceived activity level, and not objective activity explained the variance in fatigue during a CBT based treatment [57]. Interesting in a brief self-regulatory (planning) intervention conducted with patients after cardiac rehabilitation, it was found that the subjective achievement of a personal physical activity goal at posttreatment (4 months) mediated treatment effects on depressive symptoms at 12 months, and not self-reported physical activity levels [58]. These results suggest that it may not be the mere increase in PA that explains fatigue improvement, but rather the formulation of self-chosen and personally meaningful or relevant goals that not only increase the likelihood of goal progress and achievement but can also impact positively on disease related outcomes.

The authors look at the results in one way but for me this would make me suspicious of fatigue as an outcome measure in such trials. The results for fatigue may be biased by the intervention.

 

[Dolphin]

A possible explanation for this mediation effect, are that participants who are pursuing an own PA goal, may experience a change in other cognitive factors such as focusing less on symptoms and negative consequences, get a higher sense of control over fatigue, feel more confident to continue making necessary efforts and changes to recover, experience greater satisfaction with their progress, and/or increase their sense of goal ownership, leading to better disease management and improvement [20, 59]. Likewise, it may be that flexible PA related goals that take into consideration patients’ own symptoms and capability as well as the need to regulate daily activity can also explain the beneficial effects of treatment upon sustained fatigue improvement [10].

As well as general suspicion about what they are saying, I particularly dislike their referring to recovery. Recovery wasn't measured and there is not good evidence that such programmes lead to recovery.

Thus, PA goals can facilitate the increase of PA levels and maintain these levels or lead to a more balanced form of PA, taking into consideration other daily activities.

This all seems very speculative e.g. where is the evidence in the findings for a "more balanced form of physical activity". Also "PA levels" didn't increase by a statistically significant level.