Randomised controlled trial of graded exercise in chronic fatigue syndrome, 2004, Wallman et al

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Trish

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Randomised controlled trial of graded exercise in chronic fatigue syndrome
Karen E Wallman, Alan R Morton, Carmel Goodman, Robert Grove and Andrew M Guilfoyle
Med J Aust 2004; 180 (9): 444-448. || doi: 10.5694/j.1326-5377.2004.tb06019.x
Published online: 3 May 2004

Abstract
Objective: To investigate whether 12 weeks of graded exercise with pacing would improve specific physiological, psychological and cognitive functions in people with chronic fatigue syndrome (CFS).

Design: Randomised controlled trial.

Setting: Human performance laboratory at the University of Western Australia.

Participants: 61 patients aged between 16 and 74 years diagnosed with CFS.

Interventions: Either graded exercise with pacing (32 patients) or relaxation/flexibility therapy (29 patients) performed twice a day over 12 weeks.

Main outcome measures: Changes in any of the physiological, psychological or cognitive variables assessed.

Results: Following the graded exercise intervention, scores were improved for resting systolic blood pressure (P = 0.018), work capacity (W·kg-1) (P = 0.019), net blood lactate production (P = 0.036), depression (P = 0.027) and performance on a modified Stroop Colour Word test (P = 0.029). Rating of perceived exertion scores, associated with an exercise test, was lower after graded exercise (P = 0.013). No such changes were observed in the relaxation/flexibility condition, which served as an attention-placebo control.

Conclusions: Graded exercise was associated with improvements in physical work capacity, as well as in specific psychological and cognitive variables. Improvements may be associated with the abandonment of avoidance behaviours.
 
I have posted this old study because it's referred to in another thread
Investigating the relationship between physical activity and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Franklin, 2021

The problem raised by that thesis was quoted by @ME/CFS Skeptic:
7.9.1.3 Wallman et al. (2004) – excluded
A discrepancy was noted when extracting data from Wallman et al. (2004) and comparing against a previous meta-analysis (Larun et al., 2019). In Wallman et al. (2004), the total fatigue score for the exercise group and the relaxation/ flexibility was 12.6 and 14.4 respectively, resulting in a mean difference of - 1.8. In the paper by Larun et al., (2019), the post data for the exercise group and relaxation/ flexibility group was 11.06 and 15.34 respectively providing a mean difference of -4.28. This resulted in a larger effect in the meta-analysis by Larun et al., (2019) than was reported in the original paper (Wallman et al., 2004) (13% reduction in fatigue vs. 5.5%). Both research groups were contacted, however the Wallman research group no longer had the original data and this discrepancy was unable to be clarified with the Larun research group. Due to this inconsistency, the decision was made to exclude this paper from the analysis.
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Rather than diverting that thread, I decided to take a closer look at the Wallman paper, particularly because it's used in the Cochrane review.
 
Here are the fatigue scores:
Mental fatigue
GET group: Before 6.3 (5.6–7.0) After 4.5 (3.9–5.2)
Relaxation group: Before 5.6 (5.0–6.1) After 4.8 (4.2–5.5)
p = 0.023
Physical fatigue
GET group: Before: 11.6 (10.1–13.0) After: 8.1 (6.9–9.4)
Relaxation group: Before: 11.4 (10.4–12.3) After: 9.6 (8.3–10.9)
p = 0.074

So adding mental and physical fatigue:

GET group Before: 6.3+11.6= 17.9 After: 4.5+8.1 = 12.6
Reduction in combined fatigue score: 17.9-12.6 = 5.3
Relaxation group Before: 5.6+11.4 = 17.0 After: 4.8+9.6= 14.4
Reduction in combined fatigue score: 17.0-14.4 = 2.6

By taking the fatigue scores after GET, they get a between group difference of 1.8
But there was already a between group difference in the other direction of 0.9 at the start of the trial, so surely the between group reduction in fatigue score is the relevant figure. Calculating it two ways, we get 5.3-2.6=2.7, or 0.9+1.8=2.7

The key finding, if anything can be concluded from these scores, is that it was only mental fatigue not physical fatigue that was reduced significantly in the exercise group compared with the relaxation group.
 
However, the thing that stands out for me most in this trial is the description of GET, which is actually HR and symptom contingent pacing, as far as I can see. Here's the description of their version of GET:

Graded exercise program

Initial exercise duration was between 5 and 15 minutes, and intensity was based on the mean HR value achieved midpoint during the submaximal exercise tests. Graded exercise consisted of an aerobic activity that used the major large muscles of the body. Subjects could choose walking, cycling or swimming. Subjects were instructed to exercise every second day, unless they had a relapse. If this occurred, or if symptoms became worse, the next exercise session was shortened or cancelled. Subsequent exercise sessions were reduced to a length that the subject felt was manageable. This form of exercise, which allows for flexibility in exercise routines, is known as pacing

Each subject was supplied with a small laminated Borg scale, and an HR monitor to help them reach and maintain their required HR goals. Subjects rated the effort of each exercise session and recorded their exercise details in a diary.

Subjects were contacted by phone every second week over the 12 weeks to review their progress and to determine their exercise regimen for the following fortnight.
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Note that there is no mention of increasing exercise, or increasing duration of exercise, and any 'grading' seems to be cutting back to a level that doesn't provoke PEM. In fact they even call it 'pacing'.

Yet this study was apparently included in the Cochrane review.
I need to go and have a look.
 
Subjects were instructed to exercise every second day, unless they had a relapse. If this occurred, or if symptoms became worse, the next exercise session was shortened or cancelled.
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I thought the whole point of GET was to teach you that relapses aren't real and that you should carry on with increased activity.
 
From the discussion:

This improved ability to do more work may be because the exercise regimen was not associated with any relapse. This may have resulted in the abandonment of the commonly held belief by CFS sufferers that exercise results in the exacerbation of symptoms, which consequently leads to the avoidance of exercise.29,30 Additionally, graded exercise was associated with a reduction in perceived effort scores associated with the exercise test. Many studies have documented that CFS subjects report a greater sense of effort associated with exercise tests compared with control subjects.9,31,32 Gibson et al9 suggest that an abnormal sense of effort in CFS may be the result of the resetting of a sensory threshold in response to the initial onset of symptoms, and that this then becomes a learned response. Results from our study suggest that 12 weeks of graded exercise intervention may have resulted in a further resetting of this sensory threshold toward more normal values. Of importance is the implication that this reduced sense of effort may be associated with everyday work tasks that require similar work capacities.
 
This is the description of the GET from this study from the Cochrane review:
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD003200.pub8/full

Wallman 2004

Single physical therapist

Small laminated Borg Scale and HR monitor

Walking/jogging, swimming or cycling

Phone contact every 2 weeks

Every second day

From 5‐15 min, increasing to 30 min

Initial exercise duration was between 5 and 15 min, and intensity was based on the mean HR value achieved midpoint during submaximal exercise tests

Duration increased by 2‐5 min/2 wk

HR monitoring,

Borg Exertion Scale

Keep Borg within 11‐14. Adjust every 2 weeks. Average peak HR when exercising comfortably at a typical day represents participant’s target HR (± 3 bpm) for future sessions
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Not sure how to help wrt Cochrane @Trish but being horrified by the paper and its conclusions I thought I would chime in with some generalised flaw spotting.

Curious about cohort selection, I noticed, under Methods - Recruitment paragraph, they used Fukuda criteria which do not require PEM as a symptom which is a criticism of Fukuda according to some sources. It makes one wonder how many of the people recruited by adverts in the local Perth papers and GP surgeries (as stated in the same paragraph, I kid you not) would not have experienced PEM as they had a condition which did not produce PEM.

https://www.meresearch.org.uk/fukuda-criteria/
under-recognising PEM as a key feature of ME/CFS has been criticised as apt to capture too wide a range of illnesses
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https://me-pedia.org/wiki/Fukuda_criteria
if PEM option is not used the study is not considered by patients and many researchers to be a true CFS study; it is considered to be a (CF) study. Or both CFS and CF patients are in a CFS study as some patients have PEM and other patients do not making the study severely flawed and useless to either CFS or CF research
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