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. 2018 Sep 7;2018(9):CD005465. doi: 10.1002/14651858.CD005465.pub4

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
  • N: 43

  • Age ‐ mean (SD) : 76.4 (9.6)

  • Female ‐ N (%): 36 (83%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: Y


Control
  • N: 43

  • Age ‐ mean (SD) : 79.3 (12.7)

  • Female ‐ N (%): 34 (79%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: Y


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)
Interventions
  • A multimodal exercise programme based on Otago Exercise Programme consisting of strength, balance exercises plus 10 minutes flexibility warm‐up and cool down, with progressive resistance supervised by physiotherapist and group based (2 to 4 participants), and supervised walking training. Exercise programme twice weekly, walking once a week

  • Usual care: no exercise programme, participation in social activities

Outcomes
  • Rate ratio

  • Risk of falling

  • Number with multiple falls

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