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. |