Gowans 2001.
| Methods | 2 groups: exercise (AE); control Length: 23 weeks; follow‐up: none Study design: randomized clinical trial with parallel groups |
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| Participants | Female:Male: 44:6 Age (years (SD)): 44.6 (8.7); 49.8 (7.3) Inclusion: diagnosis of fibromyalgia (ACR 1990), willingness to comply with experimental protocol Exclusion: diagnosis of high blood pressure or symptomatic cardiac disease, other serious systemic diseases (eg, cancer, diabetes), intention of changing medications for anxiety or depression or seeking professional treatment for anxiety or depression during the study period, enrolled in or intended to begin an aerobic exercise program Duration of illness (years (SD)): symptoms: 9.6 (8.6); 8.4 (7.6); diagnosis: 2.8 (2.6); 4.2 (4.4) | |
| Interventions |
Exercise (n = 27): Classes for the first 6 weeks were conducted in a warm therapeutic pool; starting at 7 weeks, participants progressed to 2 walking classes in a gym and 1 pool class. Frequency: 3 hospital‐based classes/wk; Duration: 30' (5' stretching first, 20' aerobic, 5' stretching after);Intensity: low to moderate (60% to 75% age‐adjusted HRmax); Mode: water (warm) walking/running progressing to land walking/running Control (n = 23): "continue ad libitum activity" (page 520) |
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| Outcomes | Health‐related quality of life (FIQ Total), CR submax (6‐minute walk test) Other: depression (Beck Depression Index cognitive/affective), anxiety (state anxiety inventory), self‐efficacy (ASES), tenderness (tender point count), muscle function (isokinetic knee extension strength at 60 degrees) Measurements taken at 0 and 23 weeks |
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| Adherence to exercise protocols | Monitoring methods: HR and attendance were monitored; adherence criteria for efficacy analysis: must attend > 45% of exercise classes; adherence: mean attendance at exercise classes 67% (range 46%–84%) | |
| Congruence with ACSM guidelines for aerobic training | No for healthy adults, based on duration (only 20 minutes per session); met ACSM criteria for individuals who are sedentary/have no habitual activity/are extremely deconditioned | |
| Notes | Country: Canada
Language: English Study author contacted: no Funding sources/declaration of interest: Work was supported by a grant from the Toronto Hospital Auxiliary Women's Health Project on Women and Arthritis (page 528) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Subjects were stratified by sex and randomly assigned to..." (page 520) |
| 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 instrument: health‐related quality of life (FIQ Total) |
| Blinding of objective outcome assessment (detection bias) All outcomes | Low risk | CR submax (6‐minute walk test): "Their distance was recorded to the nearest meter by an assessor blinded to subjects’ group assignments" (page 520) |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants in the intervention group had no contact with those in the control group; control group did not meet |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data were analyzed by ITT |
| Selective reporting (reporting bias) | Low risk | Published reports include all expected outcomes |
| Other bias | Low risk | Study appears to be free of other sources of bias |