Effects of a Self-regulation Based Physical Activity Program (The "4-STEPS") for Unexplained CF

[Dolphin]

Int J Behav Med. 2014 Sep 4. [Epub ahead of print]

Effects of a Self-regulation Based Physical Activity Program (The "4-STEPS") for Unexplained Chronic Fatigue: a Randomized Controlled Trial.

Marques M1, De Gucht V, Leal I, Maes S.

Author information

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.

PMID: 25187111 [PubMed - as supplied by publisher]

 

[Dolphin]

I think (although am not sure) this won't show up in CFS systematic reviews as it didn't involve all CFS patients.

However, there were quite a lot of CFS patients in it: 40 out of 45 in the intervention group (88.9%) and 43 out of 45 in the control group (93.5%).

Assesment:

Adult patients meeting the CDC criteria for idiopathic chronic
fatigue (i.e. presenting a 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 an
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.

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 fatigueon daily activities (4) whether
fatigue was alleviated by rest, (5)numberofmedicalconsultations and (6) a CDC-based symptom checklist for CFS [25].
The checklist presents 19 major and minor symptoms of CFS,
asdefinedbytheCDCcriteria[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.

The authors do point out this limitation:

Third, confirmation of CF(S)
inclusion and exclusion criteria was based on self-reports
according to the CDC criteria, and it can therefore not be
excluded that some patients did not fulfil 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.

 

[Dolphin]

Here are the main results

Note that subjective fatigue is the fatigue subscale of the CIS-20 (8 questions). Fatigue severity is all 20 questions. So the fatigue subscale questions are counted in both - strip them away and the other 12 questions (concentration, motivation and activities) may not be significant.

 

[Esther12]

Ta - some discussion of the protocol for this here: http://forums.phoenixrising.me/inde...t-seems-to-be-lacking-a-decent-control.20876/

On reading the protocol I was concerned that the control was worse than nothing.

 

[Dolphin]

Here's info on goal progress:

Personal physical activity goal progress. Using a standardized goal elicitation procedure, respondents specify a personal physical activity goal which they wish to pursue over the
next months. At post-treatment, respondents were reminded
of their personal goal and asked to indicate their progress on
a 10-cm visual analogue scale (VAS), ranging from“I
haven’t started yet”(0) to “I have achieved my goal”(10)
[35]. Participants of the control group set a personal physical
activity goal during the baseline assessment session and
participants of the intervention group set their physical activity goal during the second motivational interviewing session.

Mean of 4.16, although an improvement over the control group, is a long way from 10.

 

[Scarecrow]

@Esther12 I was going to post something along the following lines. Then I noticed you already had - two years ago.

Unfortunately we've already seen how when RCTs show minor improvements in questionnaire scores, and no improvement in the amount of activity patients can take part in, this is presented as showing how wonderful the treatment is: it works without patients even needing to do more!

 

[Dolphin]

There was a big change in this score (from 41.56 to 120.67):

A self-report measure of leisure time physical activity based
on the Short Questionnaire to Assess Health-Enhancing
Physical Activity (SQUASH) [30]. Participants indicate
the number of days per week and minutes per day in which
they engage in physical activities (bicycling, walking and
other activities such as swimming). For each activity of at
least moderate intensity (≥3 METs based on the categories
of the Ainsworth’s compendium of physical activities [31,
32]), total minutes of physical activity per week is calculated by multiplying frequency (days/week) and duration (minutes/day). Total number of minutes of leisure time physical
activity (moderate to vigorousphysical activity, MVPA) per
week is calculated by taking the sum of each activity score.

However, the change in the average daily step count was quite small: 6629 to 7077 (6.8% increase). This suggests people may have cut out other activities to do increased leisure-time activity (or perhaps they didn't do as much leisure-time activity as they claimed).

 

[Dolphin]

Ta - some discussion of the protocol for this here: http://forums.phoenixrising.me/inde...t-seems-to-be-lacking-a-decent-control.20876/

On reading the protocol I was concerned that the control was worse than nothing.

They improved on 4 measures and disimproved on 7. None of the changes look that large but still can be enough to change something from not statistically significant to statistically significant. But people with CFS tend to improve a small bit on average overtime and say they are a bit better again if they have had some sort of therapy, so not an ideal control group.

 

[Dolphin]

Discussion of the pedometer results:

We observed a small increase in the daily number of steps in the intervention group (e450 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 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].

Note that they groups were already at 6500-8500 before the trial.

Ref. 42 is the PACE Trial (the increase in the 6-minute walking test was small in the GET group, but there was no change in the CBT group).

 

[Dolphin]

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.

More studies should probably highlight this issue. Although some/many of those who did not take part may have done so as they didn't feel they could exercise any more.

 

[Dolphin]

Both CBT and GET interventions are usually resource 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].

They don't mention the bigger trial of pragmatic rehabilitation, the FINE Trial, which flopped.

 

[Esther12]

I only had a quick read of that (with a mild migraine), but thought I'd post my first thoughts.

So 'Leisure Time Physical Activity' is just self-report, while 'Physical Activity' was measured objectively with a pedometer and did not find a significant improvement.

Their control group certainly did much worse than PACE's SMC, but it's difficult to know if that shows my concerns about their control were justified - we need control for their control!

@Dolphin re Goal Progress: I was just thinking the same thing, especially considering the emphasis placed upon goals in this intervention in the protocol:

Pacing, which is having an appropriate balance between activity and rest, is considered to be an important technique for reducing fatigue symptoms. Pacing implies that patients are encouraged to set realistic goals on a daily basis in terms of activity and rest periods; it is often combined with graded exercise 22,23].

CBT uses several self-regulation (SR) techniques. SR can be defined as a sequence of actions and/or steering processes intended to attain a personal goal 24]. According to SR theory, individuals set personally important goals that guide their behavior 25]. In this goal-guidance process, self-regulation cognitions (e.g. self-efficacy expectations and autonomous/controlled motivation), emotions (positive and negative affect) and skills (e.g. self-monitoring and feedback), are considered to play an important role, both in goal setting, active goal pursuit and goal maintenance/attainment 25]. As a consequence, SR models not only contribute to our understanding of the influence of life goals on medically unexplained physical symptoms (MUPS) in general, and fatigue in particular 26], but interventions based upon these models may also encourage patients to change their personal goals from symptom avoidance to more active and positive goals 27]. In their review, Maes & Karoly 25] distinguished a number of self-regulation strategies associated with behavior change and derived a set of guidelines for interventions. These self-regulation core processes are: realistic outcome expectations; illness representations; goal setting (personal goals, ownership); planning; progress evaluation and feedback; efficacy support; attention and emotion control; control over competing goals; self-monitoring; self-reinforcement; facilitate social support; goal reformulation; relapse prevention; anticipatory coping 25].

I don't really know what sort of scores are to be expected for an outcome measure like this though. Not sure how much time to invest in digging in to this.

This study examined the effect of a 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].

I'm not too happy with their justification for what should be seen as a clinically significant improvement.

So according to their pre-determined primary outcome, this was a null result?

I've got some sympathy for the argument that the sample size was too small... but I think patients have suffered more than researchers because of exaggerated claims about the efficacy of these sorts of interventions. If the effect size is smaller than you expected then you need to run a larger trial, and ideally one with a better control group.

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.

Or it could be that those patients most likely to benefit from this sort of intervention are those most likely to pursue it. It is possible that patients have some awareness of the nature of their problems and can make informed decisions about what therapies are likely to be most helpful.

They don't mention the bigger trial of pragmatic rehabilitation, the FINE Trial, which flopped.

Yeah, I noticed that too.

 

[Dolphin]

I'm just looking at the protocol (thanks to Esther12 for drawing my attention to its existence). There's no sign of quite a lot of these (including the CFS diagnosis as an outcome measure, which should assess whether they satisfy it or not at the end, otherwise it's not an outcome measure).

http://www.biomedcentral.com/1471-2458/12/202

Primary outcome
The primary outcome is the reduction of perceived fatigue severity, which is assessed by means of the Checklist of Individual Strength (CIS-20R) 35]. A difference of 7 points between the intervention and the control group on the main dimension (= the subjective feeling of fatigue subscale) of the CIS-20 R is considered to be a clinically significant difference 33,34].

Secondary outcomes
1. Fatigue severity, assessed by means of the CIR-20R 35].

2. ICF and CFS diagnosis will be assessed by means of the CDC criteria and using the CDC-CFS Symptom Inventory 36].

3. Presence of Fibromyalgia symptoms.

4. Fatigue impact is assessed by means of a modified version of the pain interference subscale of the Brief Pain Inventory (BPI) 37].

5. Work or daily activities related fatigue is assessed by means of the Need for Recovery Scale (NFR) 38].

6. Use of health care resources is measured on the basis of two questions: (1) number of visits to the primary care physician and medical specialists, (2) use of medication.

7. Work related information: currently (not) working, if currently working, number of hours working, working part-time due to fatigue, dropped out of work due to fatigue, number of days absent from work.

8. The All-or-nothing and Limiting behaviour scales from The Behaviour Responses to Illness Questionnaire (BRIQ) 39] are used to assed behavioural symptom management.

9. Anxiety and depression are measured with the Brief Symptom Inventory (BSI) 40,41].

10. Quality of sleep is assessed with five questions based on the DSM-IV criteria for sleep disorders 42] and six questions from the Pittsburgh Sleep Quality Index (PSQI) 43].

11. Number and severity of physical symptoms is measured by means of the Patient Health Questionnaire-15 (PHQ-15) 44].

12. Physical and emotional functioning is measured with the Short Form Health Survey-12 (SF-12 V.2) 45].

13. Physical activity: two different measures are used to assess physical activity level. The first is the pedometer (YAMAX SW-200), a portable device that counts the number of steps taken, by detecting hip motions. Participants are asked to use the pedometer on a daily basis for seven consecutive days and register their daily number of steps on a form that is provided to the patient. The second measure is the Sports subscale of the SQUASH 46]; in this subscale participants indicate the type of physical activity they do (e.g. swimming) including the frequency per week (e.g. 3 days per week) and duration per day (e.g. 50 minutes) for each of these activities. The intensity of each of these activities is calculated based on the Ainsworth's Compendium of Physical activities 47].

 

[Esther12]

In no way is this a solid piece of evidence, but from popular science/medicine blog, I got some vague info on pedometer data that might be of interest to people:

2000-3000 steps: About half an hours walking.

Apparently "The average U.S. adult walks about 5,900 steps daily" - whoa - I suddenly feel like I was really active before falling ill.

These classifications could be totally made-up:

Classification of pedometer-determined physical activity in healthy adults:
1) Under 5000 steps/day may be used as a "sedentary lifestyle index"
2) 5,000-7,499 steps/day is typical of daily activity excluding sports/exercise and might be considered "low active." The average American walks 5900 to 6900 steps per day, so the majority are "low active."
3) 7,500-9,999 steps/day likely includes some exercise or walking (and/or a job that requires more walking) and might be considered "somewhat active."
4) 10,000 steps/day indicates the point that should be used to classify individuals as "active".
5) Individuals who take more than 12,500 steps/day are likely to be classified as "highly active".

http://walking.about.com/cs/measure/a/locke122004.htm

That info makes the improvement report by this 4 Steps physical activity programme look even worse, but also the starting levels of physical activity look quite high.

I didn't see data specifically for the YAMAX SW-200 pedometer, but I did find people saying it was reliable and accurate.

 

[Snow Leopard]

The interaction effect for the number of steps/day was of small magnitude and not significant

As I (and others) specifically predicted in 2012.

Discussion of the pedometer results:

Note that they groups were already at 6500-8500 before the trial.

Right. Translation: CFS patients on the whole are active enough so that deconditioning does not explain their fatigue.

 

[Esther12]

Some of the PhD this is a part of is now available here: https://openaccess.leidenuniv.nl/handle/1887/31422

The rest should be available next Jan, including this bit:
http://www.sciencedirect.com/science/article/pii/S0272735815000896

Differential effects of behavioral interventions with a graded physical activity component in patients suffering from Chronic Fatigue (Syndrome): An updated systematic review and meta-analysis

• M.M. Marquesa, b, c, , ,
• V. De Guchta,
• M.J. Gouveiab,
• I. Lealb,
• S. Maesa

• a Health and Medical Psychology Unit, Leiden University, The Netherlands
• b Research I&D Psychology and Health Unit (UIPES), ISPA- University Institute, Lisbon, Portugal
• c Interdisciplinary Centre for the Study of Human Performance (CIPER), Faculty of Human Kinetics, University of Lisbon, Portugal

Received 30 June 2014, Revised 21 January 2015, Accepted 13 May 2015, Available online 4 June 2015

Highlights
•
Interventions including physical activity have beneficial effects on chronic fatigue.

•
The number of trials is modest and there is heterogeneity between them.

•
Type of setting and provider of treatment moderate fatigue severity effect sizes.

•
Minimal direct contact interventions are promising.

Abstract
An updated systematic review and meta-analysis was conducted to (1) evaluate the effects of behavioral and psychological interventions containing a graded physical activity component upon fatigue severity, physical functioning, physical activity and psychological distress, and to (2) examine potential moderator effects of trial characteristics (type of control, setting, provider, length of treatment, psychological component, flexibility in physical activity, and minimal face to face patient-provider contact). Pertinent content of selected studies was extracted and rated on a scale of methodological quality. Sixteen randomized controlled trials (N = 2004) were included in the meta-analyses. Significant small to medium effect sizes (Hedge’s g= 0.25 to g= 0.66) were found for all outcomes at post-treatment (M = 5.2 months) and follow-up (M = 11.7 months), with the exception of physical activity at post-treatment (g= 0.11). The largest effects were found for fatigue severity (g= 0.61 to g= 0.66). Subgroup analyses revealed that minimal contact interventions had additional beneficial effects upon fatigue (g= 0.96) and depression (g= 0.85). Interventions provided by psychologists-psychotherapists and interventions conducted in secondary-tertiary settings also resulted in more beneficial effects on fatigue. We found some indication of publication bias. The small number of studies and variability between them are limitations of this study. Future research should explore additional moderating effects in order to improve the effectiveness of interventions.

Maybe of interest?

"Subgroup analyses revealed that minimal contact interventions had additional beneficial effects upon fatigue (g= 0.96) and depression (g= 0.85)."

Yeah, I find that minimal contact with them perks me up a bit too.

 

[Esther12]

New paper on this from twitter:

https://twitter.com/i/web/status/816329468830740480

Efficacy of a randomized controlled brief physical activity self-regulation intervention for c hronic f atigue: Mediation effects of physical activity progress and self-regulation skills
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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 .

Search for articles by this author
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 .

Press enter key to Email the author,

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.

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

 

[Snow Leopard]

Another null result when it comes to objective measures...

Also notable that 55% of participants were working before being involved in this study... (98% of participants were women).