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. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3

Latham 2003.

Study characteristics
Methods RCT (factorial design)
Participants Setting: 5 hospitals in Auckland, New Zealand and Sydney, Australia
N = 243
Sample: frail older people recently discharged from hospital (53% women)
Age (years): mean 79
Inclusion criteria: aged ≥ 65, considered frail (one or more health problems, e.g. dependency in an ADL, prolonged bed rest, impaired mobility, or a recent fall); no clear indication or contraindication to either of the study treatments
Exclusion criteria: poor prognosis and unlikely to survive 6 months; severe cognitive impairment; physical limitations that would limit adherence to exercise programme; unstable cardiac status; large ulcers around ankles that would preclude use of ankle weights; living outside hospitals' geographical zone; not fluent in English
Interventions 1. Exercise: quadriceps exercises using adjustable ankle cuff weights 3 x per wk for 10 wks. First 2 sessions in hospital, remainder at home. Monitored weekly by physiotherapist: alternating home visit with telephone calls.
2. "Attention" control: frequency matched telephone calls and home visits from research physical therapist including general enquiry about recovery, general advice on problems, support
3. Vitamin D: single oral dose of six 1.25 mg calciferol (300,000 IU)
4. Vitamin D control: placebo tablets
Outcomes 1. Rate of falls
2. Number of people falling
3. Number of people with adverse effects from exercise (not vitamin D)
Other outcomes reported but not included in this review
Duration of the study 6 months
Notes Detailed description of exercise regimen given in paper
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Study biostatistician‐generated random sequence. Block randomisation technique.
Allocation concealment (selection bias) Low risk Computerised centralised randomisation scheme
Blinding of participants and personnel (performance bias)
All outcomes Low risk Trial with 4 arms with varying risk of bias (factorial design). 2 arms double‐blind, placebo‐controlled (low risk) and 2 arms exercise and attention control with matched frequency of visits where impact of non‐blinding likely to be low or unclear.
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Falls reported by participants who were blinded to group allocation (placebo‐controlled arms) and assessor blind to group allocation. Falls reported by participants who were aware of their group allocation (exercise and exercise control arms) but assessor blind to group allocation.
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Prospective. Falls recorded in fall diary with weekly reminders for first 10 weeks. Nurses examined fall diaries and sought further details about each fall at 3 and 6‐month visits. Reminder phone call between visits.