Pilu 2007.
| Methods | RCT | |
| Participants | Recruited from clinical activity registries of the University psychiatric unit if diagnosed with major depression. Data on age not stated (inclusion criteria range 40 ‐ 60) 100% women N = 30 |
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| Interventions | 1. Physiological strengthening exercises plus pharmacological treatment (n=10). The physical activity programme included 2 60‐minute lessons per week, held by skilled an instructor, with ISEF (Physical Education) diploma, Psychology degree and post‐degree diploma in sport Psychopathology (MS). Each session was set in three steps:
Step I: welcome and warming up (about 5 minutes)
Step II: physiological strengthening (about 50 minutes)
Step III: stretching, cooling down, goodbye (about 5 minutes). 2. Pharmacological treatment only (n = 20) Intervention delivered twice per week for 8 months |
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| Outcomes | Hamilton Rating Scale for Depression | |
| Notes | Not stated if intention‐to‐treat analysis No information given regarding drop‐out rates |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not stated |
| Allocation concealment (selection bias) | Unclear risk | Unclear |
| Blinding (performance bias and detection bias) participants | Unclear risk | Participants not blind, unclear risk of bias |
| Blinding (performance bias and detection bias) those delivering intervention | Unclear risk | Those delivering intervention were not blind, unclear risk of bias |
| Blinding (performance bias and detection bias) outcome assessors | Unclear risk | Unclear. Two different trained psychiatrists rated outcomes, including the HAM‐D, but authors did not report whether these psychiatrists were blind to treatment allocation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All those starting the intervention had outcome data reported |
| Selective reporting (reporting bias) | High risk | The authors stated that a structured diagnostic interview was performed to make a diagnosis of depression at 8 months (follow‐up), but these data were not reported |
| Other bias | Unclear risk | Unclear |