Kayo 2011.
| Methods | 3 groups: walking program (AE); strengthening exercise; control Length: 16 weeks; follow‐up: 28 weeks Study design: randomized clinical trial with parallel groups |
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| Participants | Female:Male: 90:0 Age (years (SD)): 47.7 (5.3); 46.7 (6.3); 46.1 (6.4) Inclusion: women 30‐55 years of age who agreed to participate in an exercise program 3/wk for 16 weeks and to discontinue medications for fibromyalgia 4 weeks before the start of the study; individuals who had at least 4 years of schooling Exclusion: women with contraindications to exercise based on clinical rheumatological examination, those involved in cases of medical litigation Duration of illness (years (SD)): 4.0 (3.1); 4.7 (5.7); 5.4 (3.5) |
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| Interventions |
Walking program (n = 30): 48 sessions in total. Frequency: 3/wk; Duration: ˜ 60' (warm‐up with 5‐10' stretching, conditioning stimulus, cool‐down 5'); Intensity: moderate at week 1 to vigorous by week 16 (40%‐50% to 60%‐70% heart rate reserve by week 16); Mode: supervised indoor or outdoor walking monitored by a heart rate monitor Resistance exercise training (n = 30): 48 sessions in total. Frequency: 3/wk; Duration: ˜ 60'; Intensity: high intensity (4 on 10‐point Borg scale), exercise load and intensity increased every 2 weeks (reps ‐ weeks 1 + 2: 3 sets of 10 reps with rest intervals of 1' between sets, weeks 3‐16; load ‐ weeks 1‐4, no load, weeks 5‐16, load included). The training load was individually and systematically adjusted every time the participant performed more than 15 repetitions successfully; Mode: supervised exercise protocol consisting of 11 free active exercises for upper and lower limbs and trunk muscles, with free weights and body weight performed in the standing, sitting, and lying positions Control group (n = 30): control conditions not specified, except study authors stated that participants in all 3 groups were asked to discontinue tricyclic antidepressants but were allowed to use acetaminophen (paracetamol) for pain Co‐interventions: Exercise was administered in this study as a single modality; the timing of restarting medication was monitored *For this review: only walking program and control group were considered |
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| Outcomes | Health‐related quality of life (FIQ Total), pain (VAS), fatigue (SF‐36 Vitality Scale), physical function (SF‐36 Physical Function Scale) Other: tenderness (tender point count), mental health (SF‐36 mental health) as provided by study author on request Measurements taken at 0, 8, 16, and 28 weeks |
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| Adherence to exercise protocols | Monitoring methods: HR monitored; adherence criteria: drop‐outs were those who missed more than 20% of sessions or 3 consecutive sessions; adherence: attendance rate 80% | |
| Congruence with ACSM guidelines for aerobic training | Yes | |
| Notes | Country: Brazil Language: English Study author contacted: yes, study authors provided data on outcomes (fatigue and physical function) 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) | Low risk | "The allocation sequence was based on a random number list (GraphPad Statmate version 1.0), which was organized by an investigator (MSP)" (online page 2) |
| Allocation concealment (selection bias) | Low risk | Opaque sealed envelopes were used |
| 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 (SF‐36 ‐ Vitality Scale), physical function (SF‐36 Physical Function Scale) |
| Blinding of objective outcome assessment (detection bias) All outcomes | Low risk | "All patients were clinically examined by the same rheumatologist (CSM), who was blinded to group assignment throughout the study" (pages 2‐8) |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unclear blinding of participants and personnel delivering the intervention |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data were analyzed by ITT |
| Selective reporting (reporting bias) | High risk | Outcome data for important variables (eg, tender points, SF‐36 Physical Functioning, SF‐36 Vitality, SF‐36 Mental Health) were not provided in the published report, but study authors provided these on request. RCT protocol is available (ClinicalTrials.gov ID NCT00498264) |
| Other bias | Low risk | No other serious sources of bias is evident |