Von Stengel 2011.
Study characteristics | ||
Methods | RCT | |
Participants | Setting: Erlangen‐Nürnberg, Germany N = 101 (see Notes) Sample: women recruited by mail using health insurance company database Age (years): mean 68.5 (SD 3.1), range 65 to 76 Inclusion criteria: postmenopausal; aged ≥ 65; independently community‐dwelling Exclusion criteria: diseases or medication affecting bone metabolism, neuromuscular performance or falls; implants of the lower extremity or spine; eye diseases affecting the retina; low physical capacity (< 50 W) | |
Interventions | 1. Multifunctional training + whole body vibration: group training sessions (60 min, 2 x per week) + home training sessions (20 min, 2 x per week) for 1 year. Group sessions: dancing aerobics, balance training, functional strength training + leg strength exercises on vibration platform for last 15 min (platforms vibrated at frequencies from 25 to 35 Hz, amplitude 1.7 to 2.0 mm) 2. Control: light physical exercise and relaxation programme 1 x per wk 10 wks with breaks of 10 wks between the blocks Both groups received calcium and vitamin D supplements to ensure 1500 mg calcium and 400 IE vitamin D per day, based on normal intake |
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Outcomes | 1. Rate of falls 2. Number sustaining a fracture |
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Duration of the study | 18 months | |
Notes | Randomised into 3 groups: training group (TG N = 50), training + whole body vibration (TGV N = 50), and control group (CG N = 51). Only TGV and CG included in the analysis as 50 members of the TG group are also included in the larger TG group in Kemmler 2010. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised by computer‐generated age‐stratified randomization list |
Allocation concealment (selection bias) | Low risk | Quote: "The randomization ... was performed by an independent statistician using a computer‐generated age‐stratified randomization list." Same procedure as Kemmler 2010 where randomisation was carried out by a University department. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "In contrast to other exercise studies, we tried to blind the study on the participant level by the implementation of sham exercise for the control group. Participants were not informed on the hypothesis and were unaware if they were in the real or control group. Groups were trained separately in order to prevent contact between the cohorts." |
Blinding of outcome assessment (detection bias) Falls and fallers | Low risk | Falls self reported but "outcome assessors and research assistants were not allowed to ask subjects about their allocated intervention during the measurements." |
Blinding of outcome assessment (detection bias) Fractures | Unclear risk | Participants and outcome assessors were blind to treatment group. It is unclear whether in this study radiographic confirmation was conducted. Quote: "Injurious falls, defined as falls associated with a trauma (contusion, sprain, luxation, or fracture) leading to an ailment of more than 2 days, were assessed separately", i.e. not exclusively by diary. |
Incomplete outcome data (attrition bias) Falls | Low risk | SeeAppendix 3 for method of assessment |
Risk of bias in recall of falls | Low risk | Quote: "Fall data were collected according to the PROFANE recommendation ... by a prospective reporting method via calendar." |