Rooks 2007.
| Methods |
Study setting: North America (USA). Multicentre (2 community fitness facilities, one hospital wellness centre), outpatient based, recruitment via general practitioners, letters Study design: Parallel Duration therapy: 16 weeks Follow‐up: 6 months Analysis: Paired t‐test or Kruskal‐Wallis for within‐group changes, analyses of variance for multiple comparisons to compare mean changes scores across the groups, 2‐sample t‐test, Wilcoxon rank sum test and Fisher exact test to compare baseline values and demographic variables between completers and non‐completers |
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| Participants |
Patients: Treatment group: 51 patients; 100% female, 93% White, mean age 51 years; years since diagnosis 6 (5) Control Group: 50 patients; 100% female, 83% White, mean age 48 years; years since diagnosis 5 (4) Inclusion: ACR 1990 criteria for FM, diagnosis confirmed by primary care physician, age 18‐75 years Exclusion: Medical conditions that limited a person’s ability to perform the exercise protocol or for whom moderate‐level exercise was contraindicated |
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| Interventions |
Treatment Group: Self management education program, group: basic self‐management techniques to accomplish daily activities, manage symptoms, suggested ways to incorporate wellness activities (2h/session): 16h Control Group: Active control: Aerobic and flexibility exercise (1h/session), total: 32h Co‐medication allowed: Not reported Other Co‐therapies: Not reported |
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| Outcomes |
Primary Outcomes Self reported pain: VAS pain 0‐10 Self reported negative mood: BDI 0‐54 Self reported disability: SF 36 physical function 50‐0 Acceptability: Total dropout rate Secondary Outcomes Self reported self efficacy pain: SES pain 100‐0 Self reported fatigue: FIQ fatigue 0‐10 Self reported sleep problems: Not assessed Self reported disease‐specific health‐related quality of life: FIQ 0‐100 |
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| Notes | 1. Study arms strength training, and combination a of strength training, aerobic, flexibility exercise not used for comparison 2. Reasons for dropout: ‐ Treatment Group: 7x dissatisfied with randomisation, 7x schedule conflicts, 6x lost to follow‐up, 1x other health problems, 1x travel issues, 1x FMS pain ‐ Control Group: 5x lost to follow‐up, 4x other health problems, 4x schedule conflicts, 1x travel issues, 1x in a randomisation group, 1x FMS pain 3: Attendance rates: Mean attendance rate 77% in CBT and 73% in aerobic exercise group 4. Responder analysis: 20% of the patients in the CBT group and 25% of the patients in the combined group (CBT plus exercise) reported ≥20% reduction of the FIQ‐total score at final treatment 5. Funding sources and declaration of interest of the primary researchers: The study was supported by an Arthritis Foundation Investigator Award (Dr Rooks) and National Institutes of Health grants K23 AR48305 (Dr Rooks), RO3 AR047398 (Dr Rooks), K24 AR02123 (Dr Katz), P60 AR47782 (Dr Iversen and Katz), and RR01032 (Dr Gautan). Financial disclosure: None reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated single‐page listings of random group assignment |
| Allocation concealment (selection bias) | Low risk | Individual pages were placed in an opaque envelopes, sealed, numbered sequentially and stored in a locked cabinet |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Intention‐to‐treat analyses (BOCF) reported, but only outcomes of completers reported |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Blinding of outcome assessor | Unclear risk | No detailed information |