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 |
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Interventions | Group 1: prescribed exercise therapy, 12 weeks (n = 32) Group 2: flexibility and relaxation, 12 weeks (n = 29) | |
Outcomes |
Outcomes assessed at 12 weeks (end of treatment) |
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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) |