From BMC Sports Science, Medicine and Rehabilitation, 30 August 2013.
Study protocol
The protocol for a randomised controlled trial comparing intermittent and graded exercise to usual care for chronic fatigue syndrome patients
Suzanne Broadbent and Rosanne Coutts
School of Health and Human Sciences, Southern Cross University, PO Box 157, Lismore, NSW 2480, Australia
Corresponding autho: rosanne.coutts@scu.edu.au
Abstract
BACKGROUND
Chronic Fatigue Syndrome is a debilitating disorder with an unknown aetiology but suspected multifactorial origins. Common “triggers” include severe viral infections and emotional stress.
Recent studies have also found evidence of immune dysfunction and elevated inflammatory cytokines in CFS patients, but there has been considerable variation in the outcome measures and magnitude of these studies. Currently, there is no cure for CFS but treatments include rest, specialist medical care, cognitive behavioural therapy, and
graded (self-paced) exercise.
To date, several studies have examined the efficacy of graded exercise with or without Cognitive Behavioural Therapy, with some success for patients. However, improvements in
functional capacity have not necessarily correlated with improvements in immune function, fatigue or other symptoms. This 12-week pilot trial compares graded and intermittent exercise to normal care, measuring physiological outcomes, fatigue levels, immune function and wellness.
METHODS
90 patients aged between 16 to 60 years, who meet the diagnostic criteria for CFS and have been diagnosed by their medical
practitioner, will be randomly recruited into groups consisting of Intermittent exercise, Graded exercise and usual care (Control).
The outcomes will be measured pre-study (Week 0) and post-study (Week 13). Primary outcomes are VO2peak, anaerobic threshold, peak power, levels of fatigue, immune cell (CD3+CD4+, CD3+CD8+, CD19+, CD 16+CD56+) concentrations and activation. Secondary outcomes include onset of secondary CFS symptoms (e.g. fever, swollen lymph nodes), wellness, mood and sleep patterns.
Primary analysis will be based on intention to treat using logistic regression models to compare treatments. Quantitative data will be analysed using repeated measures ANOVA with a linear model, and Cohen's effect size. Qualitative data such as participants' responses (e.g. changes in mood and other reactions) following the exercise modalities will be read and sections emarcated. A code will be applied to each segment. A prevalence of codes will be considered thematically.
DISCUSSION
The results of the trial will provide information about the efficacy of intermittent and graded exercise compared to usual
care (rest and lifestyle recommendations), contributing to the evidence for best-practice CFS management.
Trial registration: Australia and New Zealand Clinical Trials Registry ACTRN12612001241820.
From Rheumatology International, September 2013.
A possible genetic association with chronic fatigue in primary Sjögren’s syndrome: a candidate gene study
Katrine Brække Norheim, Stephanie Le Hellard, Gunnel Nordmark, Erna Harboe, Lasse Gøransson, Johan G. Brun, Marie Wahren-Herlenius, Roland Jonsson, Roald Omdal
Abstract
Fatigue is prevalent and disabling in primary Sjögren’s syndrome (pSS). Results from studies in chronic fatigue syndrome (CFS) indicate that genetic variation may influence fatigue. The aim of this study was to investigate single nucleotide polymorphism (SNP) variations in pSS patients with high and low fatigue.
A panel of 85 SNPs in 12 genes was selected based on previous studies in CFS. A total of 207 pSS patients and 376 healthy controls were genotyped. One-hundred and ninety-three patients and 70 SNPs in 11 genes were available for analysis after quality control.
Patients were dichotomized based on fatigue visual analogue scale (VAS) scores, with VAS <50 denominated “low fatigue” (n = 53) and VAS ≥50 denominated “high fatigue” (n = 140). We detected signals of association with pSS for one SNP in SLC25A40 (unadjusted p = 0.007) and two SNPs in PKN1 (both p = 0.03) in our pSS case versus control analysis. The association with SLC25A40 was stronger when only pSS high fatigue patients were analysed versus controls (p = 0.002).One SNP in PKN1 displayed an association in the case-only analysis of pSS high fatigue versus pSS low fatigue (p = 0.005). This candidate gene study in pSS did reveal a trend for associations between genetic variation in candidate genes and fatigue.The results will need to be replicated. More research on genetic associations with fatigue is warranted, and future trials should include larger cohorts and multicentre collaborations with sharing of genetic material to increase the statistical power.
From Fatigue: Biomedicine, Health & Behaviour (the journal of the International Association for CFS and ME), 2 September 2013.
Scientific and legal challenges to the functional capacity evaluation in chronic fatigue syndrome
E. Ciccolella(a) & Todd E. Davenport(b)
a) Department of Health, Exercise and Sport Sciences, University of there Pacific, Stockton, CA, US
b) Department of Physical Therapy, Thomas J Long School of Pharmacy and Health Sciences, University of the Pacific, Stockton, CA, USA
Abstract
BACKGROUND
Objective measurements of function often form the basis for legal decisions about whether a patient is fit for return to work, or conversely, entitled to disability compensation. The functional capacity evaluation (FCE) is regarded as the gold standard for measuring work capacity in plaintiffs seeking disability benefits. Yet the FCE often fails to link the unremitting fatigue of chronic fatigue syndrome (CFS) to the ability to work.
PURPOSE
To review the legal rationale and scientific evidence related to functional capacity measurements used to establish disability in individuals with CFS.
METHODS Narrative review.
RESULTS
Several legal cases demonstrate problems with the FCE as determinative of the ability to work in people with CFS. In addition, scientific studies are lacking to support the reliability and validity of the FCE in this population. The putative metabolic pathology of CFS suggests that maximal cardiopulmonary exercise testing, which combines direct measurements of functioning and metabolic status, may be more
appropriate to establish ability and disability than the FCE in this
population.
CONCLUSION
Utilization of the FCE in legal cases to establish disability in individuals with CFS may yield erroneous findings that can be addressed with the use of alternative validated measurements.