Background: Chronic Fatigue Syndrome is a debilitating disorder with an unknown aetiology but suspected\r\nmultifactorial origins. Common ââ?¬Å?triggersââ?¬Â include severe viral infections and emotional stress. Recent studies have\r\nalso found evidence of immune dysfunction and elevated inflammatory cytokines in CFS patients, but there has\r\nbeen considerable variation in the outcome measures and magnitude of these studies. Currently, there is no cure\r\nfor CFS but treatments include rest, specialist medical care, cognitive behavioural therapy, and graded (self-paced)\r\nexercise. To date, several studies have examined the efficacy of graded exercise with or without Cognitive\r\nBehavioural Therapy, with some success for patients. However, improvements in functional capacity have not\r\nnecessarily correlated with improvements in immune function, fatigue or other symptoms. This 12-week pilot trial\r\ncompares graded and intermittent exercise to normal care, measuring physiological outcomes, fatigue levels,\r\nimmune function and wellness.\r\nMethods/design: 90 patients aged between 16 to 60 years, who meet the diagnostic criteria for CFS and have\r\nbeen diagnosed by their medical practitioner, will be randomly recruited into groups consisting of Intermittent\r\nexercise, Graded exercise and usual care (Control). The outcomes will be measured pre-study (Week 0) and poststudy\r\n(Week 13). Primary outcomes are VO2peak, anaerobic threshold, peak power, levels of fatigue, immune cell\r\n(CD3+CD4+, CD3+CD8+, CD19+, CD 16+CD56+) concentrations and activation. Secondary outcomes include onset of\r\nsecondary CFS symptoms (e.g. fever, swollen lymph nodes), wellness, mood and sleep patterns. Primary analysis will\r\nbe based on intention to treat using logistic regression models to compare treatments. Quantitative data will be\r\nanalysed using repeated measures ANOVA with a linear model, and Cohenââ?¬â?¢s effect size. Qualitative data such as\r\nparticipantsââ?¬â?¢ responses (e.g. changes in mood and other reactions) following the exercise modalities will be read\r\nand sections demarcated. A code will be applied to each segment. A prevalence of codes will be considered\r\nthematically.
Loading....