GET – Page 2 – American ME and CFS Society

Randomised controlled trial of online continuing education for health professionals to improve the management of chronic fatigue syndrome: a study protocol

Abstract:

INTRODUCTION: Chronic fatigue syndrome (CFS) is a serious and debilitating illness that affects between 0.2%-2.6% of the world's population. Although there is level 1 evidence of the benefit of cognitive behaviour therapy (CBT) and graded exercise therapy (GET) for some people with CFS, uptake of these interventions is low or at best untimely. This can be partly attributed to poor clinician awareness and knowledge of CFS and related CBT and GET interventions. This trial aims to evaluate the effect of participation in an online education programme, compared with a wait-list control group, on allied health professionals' knowledge about evidence-based CFS interventions and their levels of confidence to engage in the dissemination of these interventions.

METHODS AND ANALYSIS: A randomised controlled trial consisting of 180 consenting allied health professionals will be conducted. Participants will be randomised into an intervention group (n=90) that will receive access to the online education programme, or a wait-list control group (n=90). The primary outcomes will be: 1) knowledge and clinical reasoning skills regarding CFS and its management, measured at baseline, postintervention and follow-up, and 2) self-reported confidence in knowledge and clinical reasoning skills related to CFS. Secondary outcomes include retention of knowledge and satisfaction with the online education programme. The influence of the education programme on clinical practice behaviour, and self-reported success in the management of people with CFS, will also be assessed in a cohort study design with participants from the intervention and control groups combined.

ETHICS AND DISSEMINATION: The study protocol has been approved by the Human Research Ethics Committee at The University of New South Wales (approval number HC16419). Results will be disseminated via peer-reviewed journal articles and presentations at scientific conferences and meetings.

TRIAL REGISTRATION: ACTRN12616000296437.

Source: Li SH, Sandler CX1, Casson SM, Cassar J, Bogg T, Lloyd AR, Barry BK. Randomised controlled trial of online continuing education for health professionals to improve the management of chronic fatigue syndrome: a study protocol. BMJ Open. 2017 May 10;7(5):e014133. doi: 10.1136/bmjopen-2016-014133. https://www.ncbi.nlm.nih.gov/pubmed/28495811

Graded exercise for chronic fatigue syndrome: too soon to dismiss reports of adverse reactions

Sir,

Given there is no formal system to report adverse reactions to non-pharmacological interventions such as graded exercise therapy (GET) for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), other sources of data need to be considered when evaluating safety. As noted by Clark & White, a large survey conducted in 2001 by the charity Action for ME found that 50% of patients who received graded exercise felt worse (1, 2). They also referred to a subsequent study by the same group suggesting that many patients might not have been treated by experienced therapists (3). However, the sample was small and, as in all surveys, therapist competence was not assessed.

A review of all the surveys conducted to date not only supports the view that a significant proportion of patients experience adverse reactions following GET, but also that it is premature to attribute those reactions to practitioner inexperience or inadequate training (1, 4). For example, the results of a recent survey conducted by the ME Association showed that of the 906 individuals who had received GET, 33.1% felt “much worse” and 23.4% judged themselves to be “slightly worse” (4). Similarly, a survey of patients who had been treated in the previous 3 years, i.e. following the refinement of the protocol as discussed by Clark & White, revealed that 34% of the 722 who had tried GET perceived themselves to be worse (5).

Without details of the training of the therapist and their fidelity to the treatment manual, one can only speculate about the factors associated with poor outcome. Nijs et al. (6) discussed some of the possible reasons. However, there are additional factors that deserve consideration when evaluating the efficacy and safety of GET. Firstly, the survey results may reflect, at least in part, the experiences of patients receiving treatment in a clinical setting. As has been shown in studies on other interventions, the outcomes documented in routine practice may be more realistic than those obtained in randomized controlled trials (7). Secondly, many patients may not be able to complete graded activity schedules for various reasons, including ongoing pathology. For instance, Black & McCully (8) used an accelerometer to measure activity levels before, during and after a 4-week “training period” consistent with GET. They documented an increase in activity counts lasting between 4 and 10 days, and this was associated with higher scores for pain and fatigue. The inability to sustain target activity levels was also noted by Friedberg (9), who followed the progress of one patient during 26 sessions of GET. He recorded a 10.6% decrease in mean weekly step counts, leading Friedberg to speculate that the subjective measures of improvement might have been the result of activity substitution and a corresponding reduction in perceived stress.

Finally, we were surprised that neither of the letters cited the research by White et al. (10). This elegant study supports the growing evidence of abnormal metabolic and immunological reactions to exercise in subsets with CFS. Although their sample was small, White et al. found elevated concentrations of the pro-inflammatory cytokine tumour necrosis factor-alpha at time-points of 3 h and 3 days after exercise. In addition, they documented increased levels of the anti-inflammatory cytokine transforming growth factor-beta after normal exertion. We therefore concur with Nijs et al. (6) as well as other researchers, that GET may not be appropriate for all patients with CFS and that pacing may provide a useful, acceptable and safe alternative (6, 11, 12).

You can read the rest of this letter here: https://www.medicaljournals.se/jrm/content/abstract/10.2340/16501977-0493

Comment on: Chronic fatigue syndrome. [J Rehabil Med. 2008]

Source: Kindlon T, Goudsmit EM. Graded exercise for chronic fatigue syndrome: too soon to dismiss reports of adverse reactions. J Rehabil Med. 2010 Feb;42(2):184; author reply 184-6. doi: 10.2340/16501977-0493. https://www.medicaljournals.se/jrm/content/abstract/10.2340/16501977-0493 (Full article)

Managing chronic fatigue syndrome in U.K. primary care: challenges and opportunities

Abstract:

Calls for the treatment of chronic fatigue syndrome (CFS) in primary care have been based largely on considerations of the availability and accessibility of resources rather than with reference to a firm evidence base. Treatments such as cognitive-behavioural therapy and graded exercise therapy, which have proven effective for CFS in secondary and specialist care settings, have not been adequately tested in primary care. There are several factors that may affect the generalizability of such treatments. Patients seen in primary care may differ from those seen in secondary care, in terms of both illness beliefs and social characteristics, and these factors need to be taken into account when developing and adapting treatments for primary care. While some primary care physicians experience difficulties in the diagnosis of CFS, we argue that early and authoritative diagnosis and the provision of a tangible explanation for patients’ symptoms are likely to be beneficial. Because of the scarcity of qualified specialist therapists, we need to train primary care practitioners to deliver treatments, and we need more research into the feasibility and effectiveness of doing this. Finally, the primary care setting offers opportunities for the guided development of patient self-help approaches.

Source: Wearden AJ, Chew-Graham C. Managing chronic fatigue syndrome in U.K. primary care: challenges and opportunities. Chronic Illn. 2006 Jun;2(2):143-53. https://www.ncbi.nlm.nih.gov/pubmed/17175657

Favourable results of a rehabilitation programme with cognitive behavioural therapy and graded physical activity in patients with the chronic-fatigue syndrome

Abstract:

OBJECTIVE: To determine whether a specific course of interdisciplinary rehabilitation might lead to clinically significant changes in fatigue, experienced disability and physical function in patients with the chronic-fatigue syndrome (CFS).

DESIGN: Prospective and uncontrolled.

METHOD: ‘Het Roessingh’, a rehabilitation centre in Enschede, the Netherlands, has developed an interdisciplinary clinical rehabilitation programme for patients with CFS in cooperation with the ‘Nijmeegs Kenniscentrum Chronische Vermoeidheid’ [Chronic-Fatigue Knowledge Centre] in Nijmegen, the Netherlands. In this programme, physical, mental and social activities are gradually increased on the basis of cognitive behavioural principles and graded activity. Of the 127 successive persons who enrolled for the therapy during the period from August 2000 to December 2004, 99 fulfilled the inclusion criteria; they had a median duration of symptoms of 6 years. The results of treatment were evaluated by a measurement with the ‘Checklist individuele spankracht’ [Checklist individual muscle tone] before and after treatment and the scores on the ‘Patiëntspecifieke beperkingen’ [Patient-specific disability] and the Short form-36. The measured data were complete in 74 patients.

RESULTS: Before rehabilitation, the levels of fatigue, disability and distress were high. After treatment, the studied population showed significant improvement in fatigue, experienced disability and physical function. The magnitude of the improvement was generally ‘average’. At the end of treatment, 70% of the patients were clinically less fatigued, 68% experienced less disability and 55% functioned better physically. In 34% the level of fatigue was normalised after treatment, but 9.5% of the patients was more fatigue.

CONCLUSION: The rehabilitation programme offered for CFS led to significant improvements in function and fatigue.

Comment in: [Treatment of patients with the chronic-fatigue syndrome]. [Ned Tijdschr Geneeskd. 2006]

Source: Torenbeek M, Mes CA, van Liere MJ, Schreurs KM, ter Meer R, Kortleven GC, Warmerdam CG. Favourable results of a rehabilitation programme with cognitive behavioural therapy and graded physical activity in patients with the chronic-fatigue syndrome. Ned Tijdschr Geneeskd. 2006 Sep 23;150(38):2088-94. [Article in Dutch] https://www.ncbi.nlm.nih.gov/pubmed/17036861

Treatment of patients with the chronic-fatigue syndrome

Abstract:

In the last few years, the chronic-fatigue syndrome has been recognised as an important health problem. In a recent report, the Health Council of the Netherlands suggested that the capacity for treatment be increased. Cognitive behavioural therapy and graded exercise training are treatment options of first choice.

A recently published, uncontrolled evaluation of a Dutch clinical rehabilitation programme based partly on these methods proved to be successful. Unfortunately, due to the uncontrolled character of the study, it remains unclear which elements in the treatment were responsible for the success. Which patients should be included in a costly clinical rehabilitation programme also remains unclear. More in general, there is room for empirical studies of treatment allocation, not in the least because of the frequently occurring comorbidity. Good progress has been made in the treatment of the chronic-fatigue syndrome, but we are still far removed from evidence-based, stepped care, treatment programmes.

Comment on: [Favourable results of a rehabilitation programme with cognitive behavioural therapy and graded physical activity in patients with the chronic-fatigue syndrome]. [Ned Tijdschr Geneeskd. 2006]

Source: Jonker K, van Hemert AM. Treatment of patients with the chronic-fatigue syndrome. Ned Tijdschr Geneeskd. 2006 Sep 23;150(38):2067-8. [Article in Dutch] https://www.ncbi.nlm.nih.gov/pubmed/17036854

Benefits of exercise therapy

Comment on: Acute effects of thirty minutes of light-intensity, intermittent exercise on patients with chronic fatigue syndrome. [Phys Ther. 1999]

We were interested to read in the report by Clapp et al (August 1999) that 30 minutes of intermittent walking did not exacerbate symptoms or cause any abnormal physiological response to exercise in subjects with chronic fatigue syndrome (CFS). Clapp and colleagues go on to suggest that “some individuals with CFS may be able to use low-level, intermittent exercise without exacerbating their symptoms.” They also write that “there are no data suggesting that exercises are effective as a primary treatment for patients with CFS.”

These authors do not go far enough in their recommendation and are quite wrong in their assumption regarding exercise as a primary treatment. Our group has published a randomized controlled trial showing that graded aerobic exercise therapy, properly supervised, is a significantly more effective treatment than the same amount of therapist input using only stretching and relaxation exercises.
This study showed that 52 % of patients rated themselves as “much” or “very much” better after 3 months of treatment, analyzed by intention to treat, compared with 27% of those treated with a control treatment. At the 1-year follow-up, the proportion of those who rated themselves as “much” better increased to 63% by intention-to-treat analysis (74% by completed patients’ analysis). Only 1 patient out of 33 patients rated himself “worse” after treatment, the same proportion as in the control treatment. Four patients dropped out of exercise therapy, and 3 patients dropped out of the control treatment. We excluded patients with a comorbid psychiatric disorder. We concluded that “these findings support the use of appropriate prescribed graded aerobic exercise in the management of patients with chronic fatigue syndrome.”

You can read the rest of this comment here: http://ptjournal.apta.org/content/80/1/115.long

Source: White P, Fulcher K. Benefits of exercise therapy. Phys Ther. 2000 Jan;80(1):115. http://ptjournal.apta.org/content/80/1/115.long

Indications for management in long-term, physically unexplained fatigue symptoms

Abstract:

In meetings arranged by the minister of Public Health, Welfare and Sports between general practitioners and specialists concerning chronic fatigue syndrome (CFS), suggestions for the diagnosis, treatment and assistance and support of patients with protracted physically unexplained fatiguesymptoms, were established in the light of current scientific insight.

The term ‘CFS’ is applicable in cases of fatigue complaints, of at least 6 months’ standing, reported by the patient himself and evaluated medically, for which no physical explanation has been found and which cause considerable disabilities in professional social and/or personal functioning.

The management depends on the duration of the illness. A distinction is made between an acute phase (up to one month after the first consultation; the policy is mostly expectative), a subacute phase (until 6 months after the onset of the complaints and disabilities; the management is aimed at making the patient accept the condition and persuading him or her to make an effort to promote health) and a chronic phase (from 6 months after the onset of the complaints and disabilities; the management is aimed at health-promoting behaviour and cognitions). Further (laboratory) examinations are useful only if the symptoms have not disappeared after one month (this is the case in approximately 20% of the patients); such examinations may be useful in older patients earlier.

It is important that the CFS patient learns to realize that it is useless to continue to spend energy on searching for causes and possible therapies, but that he should try to promote his own health, for instance by means of a quantified programme of activities linked to a time schedule (instead of to a level of fatigue).

Comment in:

Chronic fatigue syndrome. Ned Tijdschr Geneeskd. 1997

Source: van der Meer JW, Rijken PM, Bleijenberg G, Thomas S, Hinloopen RJ, Bensing JM. Indications for management in long-term, physically unexplained fatigue symptoms.Ned Tijdschr Geneeskd. 1997 Aug 2;141(31):1516-9. [Article in Dutch] http://www.ncbi.nlm.nih.gov/pubmed/9543738

Randomised controlled trial of graded exercise in patients with the chronic fatigue syndrome

Abstract:

OBJECTIVE: To test the efficacy of a graded aerobic exercise programme in the chronic fatigue syndrome.

DESIGN: Randomised controlled trial with control treatment crossover after the first follow up examination.

SETTING: Chronic fatigue clinic in a general hospital department of psychiatry.

SUBJECTS: 66 patients with the chronic fatigue syndrome who had neither a psychiatric disorder nor appreciable sleep disturbance.

INTERVENTIONS: Random allocation to 12 weeks of either graded aerobic exercise or flexibility exercises and relaxation therapy. Patients who completed the flexibility programme were invited to cross over to the exercise programme afterwards.

MAIN OUTCOME MEASURE: The self rated clinical global impression change score, “very much better” or “much better” being considered as clinically important.

RESULTS: Four patients receiving exercise and three receiving flexibility treatment dropped out before completion. 15 of 29 patients rated themselves as better after completing exercise treatment compared with eight of 30 patients who completed flexibility treatment. Analysis by intention to treat gave similar results (17/33 v 9/33 patients better). Fatigue, functional capacity, and fitness were significantly better after exercise than after flexibility treatment. 12 of 22 patients who crossed over to exercise after flexibility treatment rated themselves as better after completing exercise treatment 32 of 47 patients rated themselves as better three months after completing supervised exercise treatment 35 of 47 patients rated themselves as better one year after completing supervised exercise treatment.

CONCLUSION: These findings support the use of appropriately prescribed graded aerobic exercise in the management of patients with the chronic fatigue syndrome.

Comment in:

Graded exercise in chronic fatigue syndrome. Including patients who rated themselves as a little better would have altered results. [BMJ. 1997]

Managing chronic fatigue syndrome in children. [BMJ. 1997]

Graded exercise in chronic fatigue syndrome. Chronic fatigue syndrome is heterogeneous condition. [BMJ. 1997]

Graded exercise in chronic fatigue syndrome. Patients should have initial period of rest before gradual increase in activity. [BMJ. 1997]

Graded exercise in chronic fatigue syndrome. Patients were selected group. [BMJ. 1997]

Source: Fulcher KY, White PD. Randomised controlled trial of graded exercise in patients with the chronic fatigue syndrome. BMJ. 1997 Jun 7;314(7095):1647-52. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2126868/ (Full article)

Chronic fatigue syndrome and fibromyalgia

Comment on: Population study of tender point counts and pain as evidence of fibromyalgia. [BMJ. 1994]

EDITOR,-The relation between muscle pain, tender points, the chronic fatigue syndrome, and fibromyalgia are complex, and simplistic answers are inappropriate. In their paper Peter Croft and colleagues extrapolate their results to make two statements that I believe to be incorrect.’

My conclusions are based on 100 consecutive patients seen at Raigmore Hospital NHS Trust, who fulfilled precise definitions of the chronic fatigue syndrome 2 or fibromyalgia.3 The importance of this definition of the syndrome is that it has the same three month cut off for length of illness as fibromyalgia.3 Of the 100 patients, 99 (74 women, 25 men) had the chronic fatigue syndrome and one (a woman) had fibromyalgia. Of the patients with the chronic fatigue syndrome, 63 had muscle pain and 28 had tender points on examination, 23 had both, and five had no muscle pain but tender points. These results do not support the authors’ statement that the reason why fibromyalgia is not more common in Britain has been the acceptability of the chronic fatigue syndrome as an alternative diagnosis.

The authors also say that it is “inappropriate to define an entity as fibromyalgia.” As a clinical virologist, I strongly disagree with this as the distribution and number of tender points in fibromyalgia are different from those in the chronic fatigue syndrome, and the management of the two conditions is different.4 Patients with the syndrome should be advised not to increase their activities gradually until they feel 80% of normal,5 whereas patients with fibromyalgia may benefit from a regimen of increasing activity.4

You can read the rest of this comment here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2541601/pdf/bmj00468-0067b.pdf

Source: Ho-Yen DO. BMJ. Chronic fatigue syndrome and fibromyalgia. 1994 Dec 3;309(6967):1515. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2541601/

Chronic fatigue syndrome. A review from the general practice perspective

Abstract:

There is no doubt that the chronic fatigue syndrome exists. It is a condition that is debilitating and of unknown cause. Research into chronic fatigue syndrome demonstrates possible psychiatric or organic causes. The truth may be somewhere in between. Evidence for the existence of an ongoing chronic infection is now not convincing. Treatment should be based on supportive counselling, explanation, psychiatric help (both pharmacological and non pharmacological) and a graded programme of increased activity with the eventual aim of resumption of full functioning.

Comment in: Chronic fatigue syndrome. [Aust Fam Physician. 1993]

Source: Holmwood C, Shannon C. Chronic fatigue syndrome. A review from the general practice perspective. Aust Fam Physician. 1992 Mar;21(3):278-9, 283-5. http://www.ncbi.nlm.nih.gov/pubmed/1318714