King 2002.
| Methods | 4 groups: exercise only (AE); education only; education and exercise; control (wait list) Length: 12 weeks; follow‐up: 24 weeks Study design: randomized clinical trial with parallel groups |
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| Participants | Female:Male: 170:0 Age (years (SD)): 45.2 (9.4); 44.9 (10); 47.4 (9); 47.3 (7.3) Inclusion: diagnosis of fibromyalgia (ACR 1990), women 18 to 65 years of age, willing to meet 3 weeks × 12 weeks, persons involved in medico‐legal cases were not excluded Exclusion: conditions precluding ability to exercise (severe cardiac arrhythmia, dizziness, severe shortness of breath), inflammatory arthritis, systemic lupus erythematosus, rheumatoid arthritis Duration of illness (years (SD)): 7.8; 10.9; 8.9; 9.6 |
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| Interventions |
Exercise only (AE) (n = 42): Frequency: 3/wk; Duration: starting duration 10' to 15' progressing to 20' to 40', Intensity: light to moderate (60%‐75% predicted HRmax/age); Mode: walking, aquacise (deep and shallow water), or low‐impact aerobics Education only (n = 41): based upon principles of self‐management. Frequency: 1/wk; Duration: 1 1/2 to 2 hour educational session provided by a multidisciplinary team. Topics focused on potential causes of fibromyalgia, principles of self‐management (goal setting, maximizing energy for household chores or personal activities, pain or fatigue coping strategies, benefits of exercise, evaluating alternative therapies, and barriers to behavior change) Exercise + Education (n = 35): exercise same as for exercise only, and education same as for education only. Frequency: 3/wk (2 exercise sessions/wk and 1 combined educational and exercise session per week) Wait list control (n = 34): a page of written instructions for basic stretches and 5 items related to general coping strategies provided on entry to the study For a, b, c, and d: Participants were instructed not to change their present treatment (ie, medications) for the duration of the study *For this review: only exercise only, education only, and wait list control groups were considered |
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| Outcomes | Health‐related quality of life (FIQ Total), CR submax (6‐minute walk test) Other: pain (Chronic Pain Self‐Efficacy Scale), function (Chronic Pain Self‐Efficacy Scale), coping with symptoms (Chronic Pain Self‐Efficacy Scale), tenderness (tender point count), and total survey site score Measurements taken at 0, 12, and 24 weeks |
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| Adherence to exercise protocols | Monitoring methods: HR and logbooks; adherence criteria: missed 3 consecutive sessions or 12 of the 36 total; adherence: attendance 75% (21%) | |
| Congruence with ACSM guidelines for aerobic training | No, based on frequency and duration (only 3/wk, light to moderate) | |
| Notes | Country: Canada Language: English Stud author contacted: no Funding sources: Work was supported by grants from the Medical Services Incorporated Foundation and from the Health Services Research and Innovation Fund, Alberta Health, administered by Alberta Heritage Foundation for Medical Research |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Random assignment of subjects to groups was done in blocks of 4 to 16. A list was prepared prior to start of study using a table of random numbers and subject ID number (order of admission to study" (page 2621) |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information on allocation concealment to permit judgment of risk |
| Blinding of self reported outcome assessment (detection bias) All outcomes | High risk | Self‐report instruments: health‐related quality of life (FIQ Total) |
| Blinding of objective outcome assessment (detection bias) All outcomes | Low risk | CR submax (6‐minute walk test): "Baseline testing occurred before randomization" and "both assessors were blinded to the subject’s group randomization on subsequent visits" (page 2621) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded (pages 2623 and 2626). It is unlikely that care providers were blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data were analyzed by ITT for post‐intervention status; follow‐up data were reported and analyzed with completer data |
| 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 |