Luukinen 2007.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 16 months |
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Participants | Setting: Oulu, Finland Number of participants: 486 Number analysed: 437 Number lost to follow‐up: 49 Sample: identified from population and geriatric registers of Oulu Age (years): mean 88 (SD 3) Sex: 79% female Inclusion criteria: age ≥ 85; home‐dwelling; ≥ 1 risk factor for falling (≥ 2 falls in previous year, loneliness, poor self‐rated health, poor visual acuity/hearing, depression, poor cognition, impaired balance, chair rise, slow walking speed, difficulty with at least 1 ADL, able to walk outdoors, up or down stairs) Exclusion criteria: none described |
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Interventions | 1. Individual balance and gait training: Individual plan for home exercise (3 a day) or group exercise, walking exercises, self‐care exercises (duration and frequency not described). Interventions carried out by OT or physiotherapist or both 2. Control: asked to visit GP without written intervention form | |
Outcomes | 1. Rate of falls 2. Number of people who experienced 1 or more falls (risk of falling) | |
Duration of the study | 16 months median falls follow‐up | |
Adherence | Not reported | |
Notes | Source of funding: Ministry of Health and Social Affairs of Finland Economic information: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was done by the study statistician using a random numbers table" |
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 blinded to allocated group but impact of non‐blinding unclear |
Blinding of outcome assessment (detection bias) Falls | Low risk | Ascertinment of falls was the same in each group and performed by blinded assessor Quote: "Fall recording was based on regular phone calls to all participants made every second month by a research nurse ... unaware of the randomization and the interventions." |
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 | High risk | More than 20% of fall data were missing (49%) |
Selective reporting (reporting bias) | Unclear risk | Minimum set of expected outcomes not reported (adverse events not reported) |
Method of ascertaining falls (recall bias) | High risk | Interval recall Quote: "Fall recording was based on regular telephone interviews once in 2 months, but did not include diary reporting" |