Methods |
RCT (parallel group) |
Participants |
Inpatients with major depression
Mean age 49
55% women
N = 38 |
Interventions |
1. Walking training on a treadmill for 10 days (n = 10)
2. Placebo (low‐intensity stretching and relaxation) light stretching exercises for the calves, thighs, back, shoulders and pectoral muscles, as well as relaxation exercises, daily for 30 minutes (n = 18) |
Outcomes |
1. Bech‐Rafaelsen Scale (BRMS)
2. Center for Epidemiologic Studies Depression Scale (CES‐D) |
Notes |
Authors state intention‐to‐treat, but of the 39 recruited only 38 were used in the analysis. Outcome assessor for BRMS blinded to treatment allocation |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Computer‐generated block list |
Allocation concealment (selection bias) |
Low risk |
Central randomisation |
Blinding (performance bias and detection bias)
participants |
Unclear risk |
Participants aware of treatment allocation, unclear effect on bias |
Blinding (performance bias and detection bias)
those delivering intervention |
Unclear risk |
Those delivering intervention aware of allocation, unclear effect on bias |
Blinding (performance bias and detection bias)
outcome assessors |
Low risk |
A single psychologist (blinded to treatment allocation) assessed outcome using the BRMS |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
The report states 39 were randomised, but the outcome data relate to only 38. Three participants dropped out. Missing data were imputed, but authors have not accounted for the 1 participant who seems to have been randomised but was not reported in the tables of results. |
Selective reporting (reporting bias) |
Unclear risk |
All prespecified outcomes seem to have been reported, but no protocol |
Other bias |
Unclear risk |
Unclear |