Lord 2003.
| Methods | Type of study: cluster RCT (20 clusters; 7 self care and 3 intermediate care exercise clusters and 7 self care and 3 intermediate care control clusters). | |
| Participants | Number of participants randomised: 551 factorial design Losses: 21 from intervention group 22 from control N = 551 Age: range 62‐95 mean (sd) 79.5 (6.4) years Sex: 77 men, 474 women Health Status defined by authors: mixed healthy and frail Residential Status: Retirement Village Setting: Australia Inclusion: living in retirement village, Exclusion: mini mental score < 20, mental condition involving neuromuscular, skeletal, or cardiovascular system, in hospital or not present at the time of recruitment, already attending exercise class of equivalent intensity |
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| Interventions | EXERCISE GROUP (MULTIPLE): (N = 280) warm‐up period, conditioning period including aerobic exercises, specific strengthening exercises, and activities for balance, hand‐eye and foot‐eye coordination, and flexibility. CONTROL GROUP 1: (N = 290) Took part in a flexibility and relaxation program. CONTROL GROUP 2: (N = 181) No input assumed usual activity Duration and intensity: exercise group and control group 1: sessions 1 hour twice a week for 12 months. Supervisor: exercise group: trained instructor, control group 1 ‐ yoga instructor. Supervision: group Setting: community | |
| Outcomes | Postural sway on floor and foam eyes open and eyes closed (mm) (Lord sway meter)
Co‐ordinated stability test (errors).
Maximum balance range (cm) Compliance/adherence: not reported Adverse events: not reported |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was stratified by accommodation status (self care or intermediate care) and cluster size. There were 20 clusters; 7 self care and 3 intermediate care exercise clusters and 7 self care and 3 intermediate care control clusters |
| Allocation concealment (selection bias) | Low risk | Blinded person organising randomisation not involved in rest of trial |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All addressed |
| Selective reporting (reporting bias) | Low risk | All main outcome measures reported |
| Other bias | High risk | Failure to adjust for clustering |
| Blinding (participant) | High risk | Not possible |
| Blinding (assessor) | High risk | Not blinded |
| Were the treatment and control group comparable at entry? | Low risk | No differences reported on baseline characteristics with a potential to influence the effect of the intervention |
| Was the surveillance active, and of clinically appropriate duration (i.e. at least 3 months post intervention)? | High risk | Only immediately post intervention data, no follow‐up data reported |