Freiberger 2007.
| Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 24 months | |
| Participants | Setting: Erlangen, Germany Number of participants: 134 Number analysed: 127 Number lost to follow‐up: 7 Sample: community‐dwelling Age (years): mean 76.1 (SD 4.1) Sex: 44% female Inclusion criteria: ≥ 70 years, fallen in past 6 months, fear of falling, signed informed consent, completing baseline assessment Exclusion criteria: unable to walk independently, cognitive impairment (< 25 on the Digit Symbol Substitution Test) |
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| Interventions | Randomised into 3 groups: 2 intervention groups (group‐based psychomotor programme and group‐based balance, strength, flexibility, endurance) and 1 control group. Only the 2 intervention groups were included in this review 1. Group‐based psychomotor programme: strength training using dumbbells, free weights and body weight, increasing difficulty of balance exercises, motor co‐ordination, competence training, perceptual training, and home exercises; sessions 1 hour, 2 a week for 16 weeks 2. Group‐based balance, strength, flexibility, endurance: strength training using dumbbells, free weights and body weight, plus home exercises; sessions 1 hour, 2 a week for 16 weeks |
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| Outcomes | 1. Rate of falls 2. Number of people who experienced 1 or more falls (risk of falling) |
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| Duration of the study | 52 weeks | |
| Adherence | Adherence measured by session attendance 1. Group‐based psychomotor programme: 82% attended at least 24/32 sessions 2. Group‐based balance, strength, flexibility, endurance group: 84% attended at least 24/32 sessions |
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| Notes | Source of funding: The Robert Bosch Foundation, Siemens Health Insurance Economic information: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computerised random‐number generator |
| Allocation concealment (selection bias) | Unclear risk | Quote: "All randomizations were concealed". No other information given |
| 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 | Falls ascertained by the same method in both groups. Blinding of assessors performing the telephone interview was not specified |
| 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 | Low risk | Less than 20% of fall outcome data are missing (5%). Loss of fall data was balanced in the balance programme (n = 4) and psychomotor programme (n = 3) groups; reason for loss of fall data was unclear |
| Selective reporting (reporting bias) | High risk | Fall data were collected but number of falls was not reported. Adverse events not reported |
| Method of ascertaining falls (recall bias) | Low risk | Quote: "falls were collected prospectively using a monthly fall calendar between months 12 and 24; fall sheets were mailed in at the end of the month. Up to five follow‐up telephone calls were made in the event of no response after each month. If falls were reported, details were collected during a structured telephone interview" |