Nichols 1994.
| Methods | 2 groups: aerobic exercise (AE); control (daily activities not involving physical activity) Length: 8 weeks; follow‐up: none Study design: randomized clinical trial with parallel groups |
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| Participants | Female:Male: 17:2 Age (years (SD)): 47.8 (11.1); 50.8 (11.8) Inclusion: diagnosis of fibromyalgia (ACR 1990) Exclusion: history of heart disease, lung disease, uncontrolled hypertension, or orthopedic disorders that would preclude aerobic activity; participation in any regular aerobic exercise program within 6 months before the study Duration of illness (years (SD)): > 10; > 10 except for person who had 4 (years) |
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| Interventions |
Aerobic exercise (n = 10): "Each session included a warm up and cool down regimen of stretching exercises, 1 warm up and cool down lap of slow paced walking" (page 329). Frequency: 3/wk; Duration: unclear; Intensity: light to moderate (60%‐70% predicted HRmax/age); Mode: fast‐paced walking on an indoor track Control Group (n = 9): daily activities as usual not involving physical activity |
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| Outcomes | Physical function (Sickness Impact Profile) Other: mental health (Sickness Impact Profile), pain (McGill Pain Questionnaire, Brief Symptom Inventory) Measurements taken at 0 and 8 weeks |
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| Adherence to exercise protocols | Monitoring methods: HR and cadence monitored at midsession; Adherence criteria: not stated; adherence: all participants were able to achieve 60% to 70% of HRmax | |
| Congruence with ACSM guidelines for aerobic training | No, based on frequency and duration (only twice a week) | |
| Notes | Country: United States Language: English Study author contacted: no Funding sources: none stated |
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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 (page 329) |
| 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: physical function (Sickness Impact Profile) |
| Blinding of objective outcome assessment (detection bias) All outcomes | Low risk | Not applicable: Objective outcomes were not assessed |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Conflicting information regarding whether participants in the exercise and control groups interacted (pages 329 and 331) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data were balanced in numbers across exercise and control groups with similar reasons for missing data across groups |
| Selective reporting (reporting bias) | Low risk | Study protocol is not available but the published report includes all expected outcomes |
| Other bias | Low risk | Study appears to be free of other sources of bias |