Korpelainen 2006.
| Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 30 months |
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| Participants | Setting: Oulu, Finland Number of participants: 160 Number analysed: 160 Number lost to follow‐up: 0 Sample: birth cohort of women Age (years): mean 73 (SD 1.2) Sex: 100% female Inclusion criteria: hip BMD > 2 less than the reference value Exclusion criteria: "medical reasons"; use of a walking aid other than a stick; bilateral total hip joint replacement; unstable chronic illness; malignancy; medication known to affect bone density; severe cognitive impairment; involvement in other interventions |
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| Interventions | 1. Group‐based balance and strength training plus home practice: exercises increased in difficulty and used no special equipment; 1‐hour session, weekly, plus 20 minutes daily at home for 6 months each year; plus twice‐yearly seminars on nutrition, health, medical treatment and fall prevention 2. Control: twice‐yearly seminars on nutrition, health, medical treatment, and fall prevention | |
| Outcomes | 1. Rate of falls 2. Number of people who experienced 1 or more fall‐related fractures | |
| Duration of the study | 130 weeks | |
| Adherence | Adherence measured as session attendance and frequency of home programme 1. Group‐based balance and strength training plus home‐practice group: mean attendance at sessions; 77% during the first supervised 6‐month period, 75% during the second supervised period and 74% during the last supervised 6 months; mean frequency of performing home programme was 3 a week |
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| Notes | Source of funding: Finnish Ministry of Education, the Finnish Cultural Foundation, University of Oulu, Deaconess Institute of Oulu, Juho Vainio Foundation, Miina Sillanpää Foundation, Research Foundation of Orion Corporation 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: "Each participant received sequentially, according to the original identification numbers, the next random assignment in the computer list". |
| Allocation concealment (selection bias) | Low risk | The randomisation was "provided by a technical assistant not involved in the conduction of the trial" |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and personnel not blind to allocated group but impact of non‐blinding unclear |
| Blinding of outcome assessment (detection bias) Falls | Low risk | Falls measured using the same method in each group Quote: "The assessors in direct contact with participants during the study did not know to which group they had been allocated" |
| Blinding of outcome assessment (detection bias) Fractures | High risk | No radiological evidence for fractures |
| 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 | No missing falls data |
| Selective reporting (reporting bias) | High risk | Falls were measured, but number of fallers was not reported |
| Method of ascertaining falls (recall bias) | High risk | 3‐monthly retrospective recall |