Krogh 2009.
Methods | RCT (parallel group) | |
Participants | Referred from general practitioners, private psychiatrists, psychologists and psychiatric wards institutions. Included if met criteria for major depression Mean age 38.9 73.9% women N = 165 |
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Interventions | 1. Strength circuit training (n = 55) 2. Aerobic (machine‐based) training (n = 55) 3. Relaxation control (n = 55 Twice‐weekly intervention for 32 sessions delivered over a 4‐month period |
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Outcomes | Hamilton Rating Scale for Depression | |
Notes | Intention‐to‐treat analysis Significant drop‐outs in each group Changed sample size calculation after first 50 participants on basis of observed standard deviation |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computerised restricted randomisation with a block size of 8 |
Allocation concealment (selection bias) | Low risk | The block size and allocation sequence were unknown to the DEMO trial staff |
Blinding (performance bias and detection bias) participants | Unclear risk | Participants not blind, but unclear what influence this had on bias |
Blinding (performance bias and detection bias) those delivering intervention | Unclear risk | Physiotherapists delivering the intervention were not blind. Unclear how this influenced risk of bias |
Blinding (performance bias and detection bias) outcome assessors | Low risk | The assessor was blind to intervention group. The investigators asked the outcome assessors to guess intervention group. The kappa values for agreement between the right allocation and the guessed allocation were 0.15 and 0.05 for the assessments at 4 and 12 months respectively |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 137/165 were available for follow‐up at the end of the intervention. Eighteen were lost to follow‐up and 10 refused to participate (8/55 in strength group, 7/55 in aerobic group and 13/55 in the relaxation group). The authors used a likelihood‐based mixed‐effect model with an unstructured variance matrix available in SPSS, which is able to handle missing data with higher precision and power than last observation carried forward. The authors reported no significant difference between missing participants and participants included in the analyses at either 4 or 12 months, and concluded that it was reasonable to assume that the missing data were 'missing at random' |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes seem to have been reported. Protocol was published in advance of the trial |
Other bias | Unclear risk | The authors repeated power calculations part‐way through the trial, and reduced the sample size as the standard deviation was lower than anticipated |