Yang 2012.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 6 months |
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Participants | Setting: Melbourne, Australia Number of participants: 165 Number analysed: 121 Number lost to follow‐up: 44 Sample: community‐dwelling Age (years): Intervention mean 81 (5.9); Control mean 80.1 (6.4) Sex: 44% female Inclusion criteria: aged 65 years or over, living in the community, being community ambulant, requiring no walking aid or using a single‐point stick only, experiencing no more than 1 fall in the previous 12 months, having concerns about balance, and had mild balance dysfunction (i.e. Functional Reach Test score < 26 cm, Step Test score < 13 steps/15 seconds, Five‐Time Sit‐to‐Stand Test time > 17.9 seconds, had > 3 abnormal scores on the NeuroCom Balance Master) Exclusion criteria: balance performance within normal limits |
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Interventions | 1. Individual Otago Exercise Programme: Tailored home programme with no upper‐limb support. Ankle weights and exercise manual provided. 20‐minute sessions, 5 times a week, for 24 weeks, plus ≥ 30 minutes daily walking 2. Control group: provided with a fall‐prevention information booklet and continued with usual activities |
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Outcomes | 1. Number of people who experienced 1 or more falls (risk of falling) 2. Health‐related quality of life 3. Number of people who died |
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Duration of the study | 24 weeks | |
Adherence | Adherence measured by sessions performed 1. Individual Otago Exercise Programme: 26 (44%) full adherence, 8 participants (14%) reported exercising less than twice a week on average |
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Notes | Source of funding: Australian Government Department of Veterans’ Affair Economic information: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
Allocation concealment (selection bias) | Unclear risk | Method of concealment is not described in sufficient detail to allow a definite judgement |
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 | Low risk | Quote: "Assessors were blinded to 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) | High risk | Participants not blinded to group allocation |
Incomplete outcome data (attrition bias) Falls and fallers | High risk | More than 20% of fall data were missing (27%) |
Selective reporting (reporting bias) | High risk | Falls were measured, but number of falls not reported. Adverse events not reported |
Method of ascertaining falls (recall bias) | High risk | Relied on recall over 1 month. Preliminary information on falls was collected based on participants’ self‐report (retrospective recall) at the 6‐month reassessment |
ABC Scale: Activities‐specific Balance Confidence Scale ADL: activities of daily living BMD: bone mineral density DXA: dual‐energy X‐ray absorptiometry (a way of measuring bone density) ED: emergency department FaME: Falls Management Exercise FICSIT: frailty and injuries: co‐operative studies of intervention techniques GP: general practitioner HMO: health maintenance organisation m: metres MMSE: Mini Mental State Examination OT: occupational therapist PT: physical therapist/physiotherapist RCT: randomised controlled trial SD: standard deviation TUG: Timed Up and Go test wk: week x: times <: less than >: more than