Miko 2017.
| Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 12 months |
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| Participants | Setting: Budapest, Hungary Number of participants: 100 Number analysed: 97 Number lost to follow‐up: 3 Sample: community‐dwelling women Age (years): Intervention group mean 69.3 (SD 4.6), Control group mean 69.1 (SD 5.3) Sex: 100% female Inclusion criteria: women with osteoporosis, classified using the World Health Organization diagnostic criteria for established osteoporosis in postmenopausal women were eligible: bone mineral density T‐score lower than −2.5 in the lumbar spine, femoral neck or total femur region, and a history of at least 1 osteoporotic fracture Exclusion criteria: visual deficiency, severe auditiory or vestibular deficiency, advanced locomotor diseases, women who used assistive walking devices or who were unable to walk independently more than 10 metres, progressive neurological or unstable cardiovascular diseases and participation in a regular physical exercise programme in the past 6 months |
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| Interventions | 1. Individual, partially‐supervised balance training: supervised by physiotherapist in back, torso and lower‐extremity muscle‐strengthening exercises and balance training. Progressed through 3 levels; 30‐minute sessions, 2 a week, for 1 year, plus home programme 1 hour a day 2. Control group: Received osteoporosis treatment only |
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| Outcomes | 1. Rate of falls 2. Number of people who experienced 1 or more falls (risk of falling) |
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| Duration of the study | 52 weeks | |
| Adherence | Not reported | |
| Notes | Source of funding: no funding received Economic information: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Numbered series of prefilled envelopes. Method of randomisation not specified |
| Allocation concealment (selection bias) | Unclear risk | Quote: "A numbered series of prefilled envelopes specifying the group". No report of the location and whether envelopes opaque or sealed |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and personnel unblinded but impact of unblinding unknown |
| Blinding of outcome assessment (detection bias) Falls | Unclear risk | Falls reported using same method in each group. Unclear if personnel recording/confirming fall outcomes were blind to group allocation |
| 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 (3%). There were missing fall data from 1 intervention participant (due to loss of interest) and 2 control participants (1 due to loss of interest, 1 without explanation). |
| Selective reporting (reporting bias) | Unclear risk | Minimum set of expected outcomes not reported (adverse events not reported) |
| Method of ascertaining falls (recall bias) | Low risk | Fall diary kept to record any fall and the circumstances. No follow‐up phone calls noted |