Madureira 2007.
| Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 12 months |
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| Participants | Setting: São Paulo, Brazil Number of participants: 66 Number analysed: 60 Number lost to follow‐up: 6 Sample: women attending osteometabolic disease outpatient clinic Age (years): mean 74 (SD 4.7) Sex: 100% female Inclusion criteria: aged > 65; with osteoporosis Exclusion criteria: secondary osteoporosis, visual deficiency, hearing deficiency, vestibular alteration, unable to walk more than 10 m independently, contraindications for exercise training; planning to be out of town for > 4 weeks during study |
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| Interventions | 1. Group‐based balance training and walking plus home practice: 1 hour a week for 40 weeks. Encouraged to continue same exercises at home, 30 minutes 3 a week 2. Control: osteoporosis treatment, "instructions to prevent falls", and 3‐monthly clinic visits | |
| Outcomes | 1. Rate of falls | |
| Duration of the study | 52 weeks | |
| Adherence | Adherence measured by class participation and frequency of home exercises 1. Group‐based balance training and walking plus home practice: 60% attended all exercise sessions at the club; 77% performed home exercises ≥ 1 a week, 40% exercised every day and 37% performed the exercises 1 ‐ 4 a week |
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| Notes | Source of funding: not reported Economic information: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "The patients were randomized consecutively into two groups" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and personnel not blind to allocated group but impact of non‐blinding unclear |
| Blinding of outcome assessment (detection bias) Falls | Low risk | In both groups, falls were self‐reported but recorded in medical record every 3 months by "the Osteometabolic Outpatient Clinic physician blinded to the group assignment" |
| Blinding of outcome assessment (detection bias) Fractures | Unclear risk | Not applicable |
| Blinding of outcome assessment (detection bias) Hospital admission, medical attention and adverse events | Unclear risk | Not applicable |
| Blinding of outcome assessment (detection bias) Health related quality of life (self report) | Unclear risk | Not applicable |
| Incomplete outcome data (attrition bias) Falls and fallers | Low risk | Less than 20% of fall data were missing (6%). Missing data were balanced between the interention (n = 3) and control (n = 3) groups |
| Selective reporting (reporting bias) | High risk | Falls were measured, but number of fallers was not reported. Adverse events were not reported |
| Method of ascertaining falls (recall bias) | Unclear risk | Quote: "During the study, patients in both groups received a calendar and were instructed to write down falls, which were included in the same electronic medical record every 3 months by the Osteometabolic Outpatient Clinic physician blinded to the group assignment." No mention of more frequent telephone follow‐up |