Helbostad 2004.
| Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 12 months | |
| Participants | Setting: 6 local districts in Trondheim, Norway
Number of participants: 77
Number analysed: 68
Number lost to follow‐up: 9
Sample: volunteers recruited through newspapers and invitations from health workers
Age (years): mean 81 (SD 4.5)
Sex: 81% female Inclusion criteria: aged ≥ 75; fallen in last year and / or using walking aid indoors or outdoors Exclusion criteria: exercising 1 or more times weekly; terminal illness; cognitive impairment (MMSE < 22); recent stroke; unable to tolerate exercise |
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| Interventions | 1. Combined group and home‐based balance and strength training: individually‐tailored progressive resistance exercises, functional balance training, 1 hour sessions, 2 x ar week, for 12 weeks + home exercises as below (2) 2. Individual home‐balance and strength training: 4 non‐progressive functional balance and strength exercises using own body weight, 2 a day, for 12 weeks, plus 3 education group meetings |
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| Outcomes | 1. Rate of falls 2. Number of people who experienced 1or more falls (risk of falling) | |
| Duration of the study | 52 weeks | |
| Adherence | Adherence measured as sessions participated, frequency of home sessions 1. Group‐ and home‐based balance and strength training: mean training sessions participated 21/24 (range 14 ‐ 24); mean home training sessions completed a day 1.35 (SD = 0.51) 2. Individual balance and strength training: mean group meetings participated 2.5/3 (range 0 ‐ 3); mean home training sessions completed a day 1.29 (SD = 0.54) |
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| Notes | Source of funding: Norwegian Foundation for Research in Physiotherapy, Norwegian Research Council, University of Bergen Economic information: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomised into one of two exercise programs" |
| Allocation concealment (selection bias) | Low risk | Randomised by independent research office using sealed envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Cluster‐randomised trial comparing 2 types of exercise intervention. Low risk of performance bias |
| Blinding of outcome assessment (detection bias) Falls | Low risk | Falls ascertained by the same method in both groups. Assessors blind to participants' 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) | Unclear risk | Not applicable |
| Incomplete outcome data (attrition bias) Falls and fallers | Low risk | Less than 20% of fall outcome data are missing (12%). Loss of fall data was balanced in the home training (n = 4) and combined training (n = 5) groups. Reasons for data loss were balanced in the 2 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 | Monthly falls diary (prepaid postcard), telephone call if no response or fall reported |