Kovacs 2013.
Methods | Study design: RCT (individually randomised) | |
Participants |
Setting: One residential care facility, mixed‐level care, Hungary. N = 86 Sample: 81% women Age (years): 77.9 Baseline Characteristics Multimodal exercises programme
Control
Inclusion criteria: cognitive impairment (MMSE < 24), residents of nursing home, 60 years or over Exclusion criteria: living in nursing home < 2 months, < 60 years of age, unable to walk 6 metres with or without walking aid, unable to follow simple verbal exercise instructions, unstable cardiovascular or pulmonary diseases that would limit participation in exercise programme, terminal illness, planned moving from the nursing home during the study, no consent Pretreatment differences: using a frame (20.9% int, 41.9% con) |
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Interventions |
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Outcomes |
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Duration of the study | 12 months | |
Notes | Compliance reported. Cognitively impaired participants. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Judgement comment: insufficient detail for judgement |
Allocation concealment (selection bias) | Low risk | Quote: "Consecutively numbered opaque identical sealed envelopes were used for allocation." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Judgement comment: blinding not feasible |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Judgement comment: carers recorded falls not blinded to group allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: attrition numbers and reasons balanced between groups |
Selective reporting (reporting bias) | Low risk | Judgement comment: although no protocol was identified, falls outcomes were reported clearly and as multiple measures (fallers, falls, recurrent fallers, as n and RR) |
Method of ascertaining falls | Low risk | Judgement comment: falls recorded concurrently on calendar using clear definition |
Baseline imbalance | High risk | Judgement comment: significant difference between groups in the proportion using a frame, not adjusted for in analysis |
Other bias | Low risk | Judgement comment: none detected |