Faber 2006.
Methods | Type of study: cluster RCT ‐ 15 clusters homes randomly assigned to 1 of the 2 exercise interventions | |
Participants | Number of participants randomised: 278 Losses: 76 Age: FW = 85.4 (5.9); IB = 84.4 (6.4); CON = 84.9 (5.9) Sex: 188 women Health status defined by authors: frail and pre‐frail Residential status of participants: care homes Setting: 16 care homes, the Netherlands Inclusion: not specified Exclusion: unable to walk 6m independently (use of walking aid allowed); impaired cognition preventing compliance with intervention; medical condition the contraindicated. |
|
Interventions | EXERCISE GROUP (GBFT) : Functional walking (FW) (n = 66) = 10 exercises focus on balance, mobility and transfer training e.g.. Sit‐stand, reaching, stepping forward and sideways, step on or over obstacle, stair walking, heel and toe stands, walking and turning, tandem and single leg standing EXERCISE GROUP (3D) (n = 80) = Tai Chi principles CONTROL GROUP (n = 92): no exercise Duration and intensity: 1 session per week for 4 weeks, 2x week for 16 weeks. Each session lasts 90 mins, including 30 min social. Supervisor: instructor and assistant Supervision: maximum size of group was 15. Setting: care homes |
|
Outcomes | Physical Performance Scale (PPS) comprised (walking speed test (ms), timed chair stands (s), TUG (s), FICSIT‐4 balance test (s)) Compliance/Adherence: on average 32 out of 36 sessions completed, median relative compliance was 88% for FW and 84% for IB Adverse events: not reported |
|
Notes | Data for outcomes were reported as a composite score PPS and individual components were not reported separately | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | 2 levels of block‐wise randomisation. Homes randomly assigned to 1 of the 2 exercise interventions using sealed envelopes; participants in each of the homes randomised across intervention and control using computer generated random numbers |
Allocation concealment (selection bias) | Low risk | Reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Used linear regression models which account for missing data but not in mean and SD values reported in table. The analysis may have accounted for this? |
Selective reporting (reporting bias) | Low risk | Intended measures reported on |
Other bias | High risk | Failure to adjust for clustering |
Blinding (participant) | High risk | Not possible |
Blinding (assessor) | Low risk | Reported |
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)? | Low risk | 52 week follow‐up for primary outcome of falls not other measures |