Ramsay 2000.
| Methods | 2 groups: exercise class (AE); single session Length: 12 weeks; follow‐up: 24 weeks and 48 weeks Study design: randomized clinical trial with parallel groups |
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| Participants | Female:Male: not specified Age (years (SD)): not specified for either group Inclusion: diagnosis of fibromyalgia (ACR 1990) Exclusion: unstable pharmacological treatment in the first month before entry to the study Duration of illness (years (SD)): not specified for either group |
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| Interventions |
Exercise class (n = 37): Frequency: 1/wk; Duration: 60' and home program: not specified;Intensity: not specified; Mode: graded circuit exercises consisting of step‐ups, sitting to standing, skipping, jogging on the spot, alternate side bends, circling arms with increasing weights, plus encouragement to continue and increase exercises at home Single session (n = 37): demonstration of aerobic exercises, stretching and relaxation technique, plus home program; Frequency: 1 session; Duration: 60'; home program: not specified; Intensity: not specified; Mode: written advice on aerobic exercises plus stretching and relaxation |
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| Outcomes | Pain intensity (VAS), physical function (HAQ) Other: tenderness (tender point count), depression (Hospital Anxiety and Depression questionnaire), anxiety (Hospital Anxiety and Depression questionnaire), sleep (number of nights per week with difficulty; average number of hours slept/night over past week) Measurements taken at 0, 12, 24, and 48 weeks |
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| Adherence to exercise protocols | Monitoring methods: attendance; adherence criteria: not specified; adherence: carrying out 72%, 50% of home exercise sessions over the 12 weeks (median values) | |
| Congruence with ACSM guidelines for aerobic training | No, based on frequency (only once a week) | |
| Notes | Country: United Kingdom Language: English Study author contacted: no Funding source/declaration of interest: Work was supported by The Scottish Office Department of Health |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information on the method used to generate the allocation sequence to permit judgment of risk |
| Allocation concealment (selection bias) | Unclear risk | No description of the method used for allocation concealment to permit judgment of risk |
| Blinding of self reported outcome assessment (detection bias) All outcomes | High risk | Self‐report instruments: pain intensity (VAS), physical function (HAQ) |
| Blinding of objective outcome assessment (detection bias) All outcomes | Unclear risk | Information on abstract and title indicates 'observer‐blinded' ‐ unclear who is the observer |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information on blinding of participants and personnel to permit judgment of risk |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data were analyzed using ITT |
| Selective reporting (reporting bias) | Low risk | Study protocol is not available but it is clear that the published report includes all expected outcomes |
| Other bias | Unclear risk | Insufficient information for assessment of whether an important risk of bias exists |