Fontaine 2010.
| Methods | 2 groups: lifestyle physical activity (AE); education (control) Length: 12 weeks; follow‐up: 26 weeks and 52 weeks Study design: randomized clinical trial with parallel group |
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| Participants | Female:Male: 73:0 Age (years (SD)): 46.4 (11.6); 49 (10.2) Inclusion: diagnosis of fibromyalgia (ACR 1990), patient at Johns Hopkins Arthritis Center, affiliated Johns Hopkins Rheumatology clinics Exclusion: meeting US Surgeon General’s 1996 recommendation for physical activity for previous 6 months (ie, not engaging in moderate‐intensity physical activity for 30 minutes on 5 days per week or in vigorous physical activity 3 times per week for 20 minutes each time during the previous month), acute or chronic medical condition that could preclude active participation (cancer, coronary artery disease), intent to change medications that might affect mood, intent to seek professional treatment for anxiety or depression during the study period, not unwilling to make the required time commitment Duration of illness (years (SD)): 5.9 (5.1); 9.6 (6.8) |
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| Interventions |
Lifestyle physical activity (n = 43): Increase moderate‐intensity physical activity by helping participants find ways to accumulate short bouts of physical activity throughout the day. Frequency: 5‐7 times/wk; Duration: 60';Intensity: moderate; Mode: walking (the most common form of LPA) and other forms (eg, gardening/mowing the lawn) of household activity (eg,vacuuming); and sports activity (eg, cycling, swimming, field hockey) Education (n = 33): Provide education and control for effects of being enrolled in a clinical trial and receiving increased attention and social support; Frequency: 1/mo; Duration: 90‐120'; Intensity: not applicable; Mode: education, question and answer, and social support |
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| Outcomes | Health‐related quality of life (FIQ Total), pain (VAS for pain), fatigue (Fatigue Severity Scale ‐ FSS), CR submax (6‐minute walk test) Others: depression (Center for Epidemiological Studies Depression Scale ‐ CES‐D), tenderness (tender point count), physical activity level (pedometer); perceived improvement ("Since the start of the study, how much change has there been in your fibromyalgia?") Measurements taken at 0 and 12 weeks |
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| Adherence to exercise protocols | Monitoring methods: intensity monitored by pedometer once a week and diaries used to track mode; adherence criteria: not specified; adherence: unknown | |
| 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: Work was supported by NIH/NIAMS (National Institutes of Health/National Institute of Arthritis and Musculoskeletal Skin Diseases) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Particiants were randomized via a coin flip at a 1:1 allocation ratio to each of the two groups" (page 5) |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit evaluation of risk |
| 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 for pain), fatigue (Fatigue Severity Scale ‐ FSS) |
| Blinding of objective outcome assessment (detection bias) All outcomes | Unclear risk | CR submax (6‐minute walk test): no information on blinding 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 | Reasons for missing outcome data unlikely to be related to true outcomes; missing outcome data were balanced in numbers across intervention groups |
| Selective reporting (reporting bias) | Low risk | Study protocol is available (clinicaltrials.gov NCT00383084) and all of the study's prespecified outcomes of interest in the review have been reported in the prespecified way |
| Other bias | Low risk | Study appears to be free of other sources of bias |