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. 2017 Apr 25;2017(4):CD003200. doi: 10.1002/14651858.CD003200.pub7
Methods RCT, 2 parallel arms
Participants Diagnostic criteria: CDC 1994
Number of participants: N = 68
Gender: 47 (77%) female Age: 16 to 74 years (average 43.3 (12.7) in the exercise group and 45.7 (12.5) in the control group)
Earlier treatment: NS
Co‐morbidity: possible depression not stated, 16 (26%) used antidepressants
Illness duration: no initial difference between groups
Work and employment status: not stated Setting: primary care
Country: Western Australia
Interventions Group 1: prescribed exercise therapy, 12 weeks (n = 32) Group 2: flexibility and relaxation, 12 weeks (n = 29)
Outcomes
  • Physiological assessments (heart rate, blood pressure at rest and during exercise, lactate and oxygen consumption)

  • Perceived exertion (Borg Scale, rating of perceived exertion (RPE))

  • Energy expenditure (Older Adult Exercise Status Inventory)

  • Fatigue (Fatigue Scale, FS; 11 items)

  • Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)

  • Cognitive function (computerised version of the modified Stroop Color Word Test)

  • Changes in overall health (Global Impression Scale, score between 1 and 7, where 1 = very much better, 4 = no change)


Outcomes assessed at 12 weeks (end of treatment)
Notes Supplementary HADS data obtained from study authors for first version of this review
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "...patients were randomised (by an independent investigator)"
Allocation concealment (selection bias) Unclear risk Not adequately described
Blinding (performance bias and detection bias) of participants and personnel? High risk Not possible to blind participants or personnel (supervisors) to treatment allocation
Blinding (performance bias and detection bias) of outcome assessors? High risk Blinding not possible for self‐reported measurements (e.g. FS, SF‐36)
Incomplete outcome data (attrition bias) All outcomes Low risk 2 of 34 (6%) participants in the ET group withdrew: "...for reasons not associated with the study"
5 of 34 (15%) participants in control group withdrew: "for reasons not associated with the study, and a further subject was excluded because her body mass index (44 kg/m2) prevented her form participating in the exercise test"
Selective reporting (reporting bias) Unclear risk All primary outcomes stated under Methods were reported; however, as the trial protocol is not available, we cannot categorically state that the review is free of selective outcome reporting
Other bias Unclear risk Baseline data differences between groups for anxiety (7.3 in exercise group vs 8.7 in control group) and mental fatigue (6.3 vs 5.6)