Trombetti 2011.
| Methods | Study design: RCT (cross‐over at 6 months) Number of study arms: 2 Length of follow‐up: 6 months |
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| Participants | Setting: Geneva, Switzerland Number of participants: 134 Number analysed: 134 Number lost to follow‐up: 0 Sample: volunteers recruited by advertising etc. Age (years): 75.5 (SD 6.9) Sex: 96% female Inclusion criteria: aged ≥ 65; community‐dwelling; no previous experience of Jaques‐Dalcroze eurhythmics (except during childhood); high risk of falling (≥ 1 fall after the age of 65, impaired balance, or physically frail) Exclusion criteria: neurological or orthopaedic disease seriously affecting gait and balance; progressive or unstable medical conditions limiting participation; dependent on walking aids, e.g. canes and walkers |
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| Interventions | 1. Group‐based balance and gait training: music‐based multitask exercise programme gradually increasing in difficulty to challenge balance, 1 hour, 1 a week for 6 months 2. Control: received intervention after 6 months |
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| Outcomes | 1. Rate of falls 2. Number of people who experienced 1 or more falls (risk of falling) 3. Number of people who died |
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| Duration of the study | 26 weeks | |
| Adherence | Adherence measured by percentage completed study, class attendance 1. Group‐based balance and gait training: mean attendance rate; 78%. 83% completed the intervention, of whom 77% attended at least 20 classes (i.e. 80% of the classes) |
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| Notes | Source of funding: Loterie Romande Geneva, Carigest SA, Gertrude Hirzel Foundation, Leenaards Foundation, Oltramare Foundation, Eagle Foundation, Foundation for Geneva (Georges Junod Fund), Delta réseau de soins Geneva, Helsana Economic information: not reported Falls data from 6 months (before cross‐over) used for analysis in the review |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "subjects were randomized … according to a computer‐generated list … using a permuted block randomization design" |
| Allocation concealment (selection bias) | Low risk | Quote: "subjects were randomized … according to a computer‐generated list prepared by an independent statistician" |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and personnel not blinded to allocated group but impact of non‐blinding unclear |
| Blinding of outcome assessment (detection bias) Falls | Unclear risk | Participants self‐reported falls Quote: "Participants who failed to return the diary or provided incomplete data were contacted by telephone." Not clear whether this assessor was 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 | Method of ascertaining adverse events, and presence of blinding, unclear |
| 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 | No missing fall data |
| Selective reporting (reporting bias) | Unclear risk | Fall outcomes were prespecifed in the prospective trial registration. Adverse events (part of the minimum set of expected outcomes) were noted only in the results |
| Method of ascertaining falls (recall bias) | Low risk | Quote: "Falls were prospectively monitored for 12 months and recorded daily using a diary mailed monthly to the study coordinator. Participants who failed to return the diary or provided incomplete data were contacted by telephone" |