Voukelatos 2015.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 12 months |
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Participants | Setting: Sydney, Australia Number of participants: 386 Number analysed: 339 Number lost to follow‐up: 47 Sample: community‐dwelling Age (years): mean 73.2 (range 65 ‐ 90) Sex: 74% female Inclusion criteria: 65 years and over community‐dwelling inactive (i.e. < 120 minutes of exercise a week) mobile (i.e. able to walk at least 50 m with minimal aid); able to communicate in English Exclusion criteria: medical condition precluding participation in the study, participating in another study |
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Interventions | 1. Individual walking programme: 48‐week self‐paced walking programme by manual; focused on walking duration (12 weeks), walking intensity (12 weeks), maintaining the level of walking achieved in the previous stages (24 weeks); 6 telephone calls to help modify and support adherence 2. Control group: Mailed information about health issues, 6 telephone calls to discuss health information |
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Outcomes | 1. Rate of falls 2. Number of people who experienced 1 or more falls (risk of falling) 3. Health‐related quality of life 4. Number of people who died |
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Duration of the study | 48 weeks | |
Adherence | Not reported | |
Notes | Source of funding: NSW Ministry of Health Economic information: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation scheme used randomised permuted blocks of 6 and 4 prepared by the chief investigator |
Allocation concealment (selection bias) | Low risk | Sequentially‐numbered sealed opaque envelopes |
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 | Blinding not described. Insufficient information to permit judgement. |
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 | Unclear risk | Less than 20% of fall data were missing (12%). Missing data were unbalanced across groups, with 33/192 participants missing from the intervention group and 14/194 missing from the control group. The reasons for missing fall data at 24 months were not clear |
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 | Monitored for 48 weeks through monthly calendars. When participants reported a fall, they were contacted by telephone to confirm the fall and document any fall‐related injuries |