Hoffman 2010.
Methods | Randomised controlled trial. | |
Participants | Eighty participants were recruited through posted and online advertisements in local rehabilitation clinics, newspapers, and websites. Local rehabilitation physicians and psychologists were given information and flyers for the study. Inclusion criteria: Self‐reported TBI, severe enough to have required medical evaluation or hospital admission immediately after injury; TBI from 6 months to 5 years prior to enrolment; score of 5 or more on the Patient Health Questionnaire‐9 (PHQ‐9), indicating at least a mild level of depressive symptoms; sufficient cognitive ability to maintain an exercise log and independently participate in the study, or have the involvement of a support person to facilitate involvement. Exclusion criteria: Having a medical condition that would preclude or limit exercise; current suicidal ideation with intent or plan; current pregnancy; current regular exercise program three times a week or more; any physical barrier to the use of standard aerobic exercise equipment. |
|
Interventions | The intervention was supervised exercise training once a week in a gymnasium with a research education trainer and certified athletic trainer. Each session included; 15 minutes of education on an exercise‐related topic; 15 minutes of warm‐up exercises consisting of stretching and walking; 30 minutes of aerobic exercise. In addition the intervention included a home program, whereby each participant was asked to perform 30 minutes of aerobic exercise at least 4 times a week, in addition to the supervised exercise session. Control group participants were given instruction that they would be contacted for assessment after 10 weeks. They were given no particular instructions regarding exercise. |
|
Outcomes |
Primary outcome measure: Beck Depression Inventory (BDI) Secondary outcome measures: Brief Pain Inventory Pittsburgh Sleep Inventory Head Injury Symptom Checklist SF‐12 Health Survey Craig Handicap Assessment and Reporting Technique ‐ Short Form (CHART‐SF) Perceived Quality of Life (PQOL) |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequence was created using a random number generation program (personal communication with primary author). |
Allocation concealment (selection bias) | Low risk | Use of sealed envelopes to ensure blinding. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not possible because study was a comparison between an active intervention (exercise program) and a wait‐list control. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessment was completed by a research assistant blind to group allocation (personal communication with primary author), however, the primary outcome measure was a self‐report scale and therefore subject to bias since the participants were aware of the intervention to which they were assigned. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Eighty participants were randomised, with 76 completing the outcome assessment. Missing outcome data were balanced between groups, with a similar reason for missing data (participants unable to be contacted for follow‐up). |
Selective reporting (reporting bias) | Low risk | Table 2 reports data on each measure, for each group, at each time‐point. |
Other bias | Unclear risk | ‐ |