Hoffman 2010.
Methods | RCT | |
Participants | People with a history of traumatic brain injury occurring between 6 months and 5 years prior to trial with at least mild depression (n = 80) | |
Interventions | 1. Aerobic exercise of participant's choosing. 60 minutes of gym‐based supervised exercise per week and 4 x 30‐minute home exercise sessions per week (n = 40; 38% men) 2. No intervention in control group (n = 40; 50% men) |
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Outcomes | Beck Depression Inventory Score | |
Notes | The control group were informed they could participate in exercise programme post‐trial intervention period. Authors report that both intervention and control groups showed a substantial increase in exercise. SDs received from author |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participation open to anyone who met inclusion criteria. Random distribution of sealed envelopes. |
Allocation concealment (selection bias) | Low risk | Use of sealed envelopes |
Blinding (performance bias and detection bias) participants | Unclear risk | All participants informed of nature of the study and both groups increased total amount of exercise over study period |
Blinding (performance bias and detection bias) those delivering intervention | Unclear risk | No detail provided |
Blinding (performance bias and detection bias) outcome assessors | High risk | BDI self report |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence of missing data |
Selective reporting (reporting bias) | Low risk | All findings reported |
Other bias | Unclear risk | Unclear |