Clemson 2010.
| Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 6 months | |
| Participants | Setting: Sydney, Australia Number of participants: 34 Number analysed: 34 Number lost to follow‐up: 0 Sample: volunteer community‐dwelling men and women recruited by various strategies Age (years): mean 82 (SD 5.9) Sex: 47% female Inclusion criteria: aged > 70 years; ≥ 2 falls or an injurious fall in previous year Exclusion criteria: cognitive impairment; no conversational English; unable to walk independently; resident in nursing home or hostel; unstable or terminal illness that would preclude planned exercises; neurological conditions, e.g. Parkinson's disease |
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| Interventions | 1. LiFE (Lifestyle approach to reducing Falls through Exercise) programme ‐ progressive balance and strength training embedded in daily life activities: taught in 5 home visits + 2 booster visits over 3 months + 2 phone calls; 6‐month programme 2. Control group: no intervention | |
| Outcomes | 1. Rate of falls 2. Number of people who experienced 1 or more falls (risk of falling) | |
| Duration of the study | 24 weeks | |
| Adherence | Not reported | |
| Notes | Source of funding: University of Sydney Bridging Grant Economic information: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomisation was conducted … using a random numbers table" |
| Allocation concealment (selection bias) | Low risk | Quote: "Randomisation was conducted by an investigator not involved in assessment or intervention …" "Once baseline assessments were completed by the research assistant (RA), participants were then allocated in order of completion from the generated lists by the blinded investigator" |
| 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 | Quote: "An RA who was not involved in the intervention and masked to the group allocation conducted all assessments. Falls surveillance was by daily calendar, which participants mailed monthly, using pre‐addressed envelopes to the RA. An investigator telephoned any participant who failed to return the calendar or who reported a fall." Unclear whether the investigator carrying out the telephone calls 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 | Not applicable |
| Blinding of outcome assessment (detection bias) Health related quality of life (self report) | High risk | Participants unblinded to group allocation |
| Incomplete outcome data (attrition bias) Falls and fallers | Low risk | Less than 20% of fall outcome data are missing (9%). Balance in withdrawals in intervention (n = 1) and control (n = 2) groups, with balanced reasons for withdrawal between the groups |
| 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 | Quote: "Falls surveillance was by daily calendar, which participants mailed monthly, using pre‐addressed envelopes …" |