Fontaine 2007.
| Methods | 2 groups: lifestyle physical activity (AE); education (control) Length: 12 weeks; follow‐up: none Study design: randomized clinical trial with parallel groups |
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| Participants | Female:Male: 46:2 Age (years (SD)): 48 (10); 52 (8) Inclusion: men and women 18 years of age or older, diagnosis of fibromyalgia (ACR 1990), sedentary for 6 months before enrolment, stable on medication regimen for ≥ 3 months before enrollment Exclusion: acute or chronic condition (eg, cancer, coronary artery disease), inflammatory disease, or other pain disorders; intending to seek professional treatment for anxiety or depression during the study period; unwilling to participate in a physical activity program, assistive device required to ambulate Duration of illness (years (SD)): 7(5); 7(4) |
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| Interventions |
Lifestyle physical activity (n = 22): Frequency: 5‐7/wk; Duration: 10' and increased daily duration 5'/wk; once participants accumulated at least 30', they were encouraged but were not prescribed longer durations;Intensity: moderate; Mode: "brisk walking was primary mode, although other forms were also recommended" (page 4). Non‐exercise component: "90' group session every 2 weeks for 12 weeks, group sessions based on a cognitive‐behavioral physical activity promotion program" (page 4) Education (n = 26): education on fibromyalgia symptoms, diagnosis, and treatment for 3 months. Frequency: 1/mo; Duration: 90' |
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| Outcomes | Health‐related quality of life (FIQ Total), pain (VAS), fatigue (FSS), CR submax (6‐minute walk test) Others: tenderness (tender point count), patient‐rated global (self‐perceived) change Measurements taken at 0 and 12 weeks |
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| Adherence to exercise protocols | Monitoring methods: logs to track mode; adherence criteria: none stated; adherence: attendance rate 71% | |
| Congruence with ACSM guidelines for aerobic training | Yes | |
| Notes | Country: United States Language: English Study author contacted: yes, study author confirmed that participants from the 2 studies (Fontaine 2007 and Fontaine 2010) were different Funding source/declaration of interest: none reported |
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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 |
| Blinding of self reported outcome assessment (detection bias) All outcomes | High risk | Self‐report instruments: health‐related quality of life (FIQ Total), pain intensity (VAS), fatigue (FSS) |
| Blinding of objective outcome assessment (detection bias) All outcomes | Unclear risk | CR submax (6‐minute walk test): no information on blinding of assessors |
| 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 | Missing outcome data were balanced in numbers across intervention groups, with similar reasons for missing data across groups |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgment of risk |
| Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias existed |