Grahn Kronhed 2009.
| Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 12 months | |
| Participants | Setting: Linköping, Sweden Number of participants: 65 Number analysed: 65 Number lost to follow‐up: 0 Sample: women with osteoporosis identified from Linköping Hospital, Osteoporosis Unit files Age (years): mean 71.4, range 60 to 81 Sex: 100% female Inclusion criteria: BMD measured within previous 9 months and T‐score ≤ −2.5 SD Exclusion criteria: enrolled in a pharmacological RCT; requiring indoor walking aids; cognitively impaired (MMSE < 20); severe heart disease, malignancy, recent arthroplasty, unhealed fractures; unable to understand Swedish |
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| Interventions | 1. Group‐based strength and balance training: supervised and progressed using body weight, pulleys, leg press, exercises on balance boards and weight shifting on trampoline; 1 hour, 2 a week for 4 months 2. Control: no intervention. Instructed not to change exercise routines for 1 year | |
| Outcomes | 1. Rate of falls 2. Health‐related quality of life |
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| Duration of the study | 52 weeks | |
| Adherence | Adherence measured by completion of sessions 1. Group‐based strength training group: completed mean of 24/30 sessions (median = 25, range 13 ‐ 30) |
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| Notes | Source of funding: Östergötland County Council and the Faculty of Health Sciences, Linköping University, Region Västra Götaland, the Stohne’s foundation, and Sanofi‐AventisÖstergötland County Council and the Faculty of Health Sciences, Linköping University, Region Västra Götaland, the Stohne’s foundation, and Sanofi‐Aventis
Economic information: not reported No participants sustained a fracture during follow‐up |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Method not described but assume it was truly random, given that Quote: "an independent statistical unit randomised the participants" |
| Allocation concealment (selection bias) | Low risk | Quote: "An independent statistical unit randomized the participants" |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and personnel not blinded to allocated group but impact of non‐blinding unclear |
| Blinding of outcome assessment (detection bias) Falls | Low risk | Falls ascertained by the same method in both groups Quote: "… participants were followed‐up concerning … falls … for 1 year by the independent statistical unit." Probably blind to allocated group or at least unlikely to introduce bias. |
| Blinding of outcome assessment (detection bias) Fractures | High risk | Participant‐reported fractures with no description of confirmation |
| 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 blind to allocated group |
| Incomplete outcome data (attrition bias) Falls and fallers | Low risk | No missing fall data |
| Selective reporting (reporting bias) | High risk | Fall data obtined but number of fallers not reported. Adverse events not reported |
| Method of ascertaining falls (recall bias) | Low risk | Quote: "... participants reported number of falls each week for the 1‐year study period" |