| Methods |
RCT (individually randomised) |
| Participants |
Setting: 4 nursing homes (high‐level nursing care), USA
N = 190
Sample: 85% women
Age (years): mean (SD) intervention group 87.3 (8.0), control group 88.6 (6.7)
Inclusion criteria: incontinent; no in‐dwelling catheter; follows one stage commands; not Medicare Part A for post acute care or terminal; occupying long stay bed
Exclusion criteria: none stated |
| Interventions |
"FIT": incontinence care and functional exercises delivered by research staff. Every 2 hours from 08.00 to 16.00, 5 days a week, for 8 months. At each session patients prompted to toilet and changed if wet; encouraged to walk (or mobilise in wheel chair if not ambulatory); carried out sit‐to‐stand exercises with minimal assistance; offered fluids to drink before and after each episode. Upper body resistance training (arm curls and arm raises) at one episode per day. Individually tailored to meet weekly goals (up to 8 sit‐to‐stands, and up to 10 minutes walking (wheeling) per episode) Control: usual care |
| Outcomes |
|
| Duration of the study |
8 months |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "... subjects were randomized within NHs by computerized programs into intervention and control groups." |
| Allocation concealment (selection bias) |
Unclear risk |
Insufficient information on process of allocation to permit judgement of 'Low risk' or 'High risk' |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Judgement comment: blinding not feasible |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Falls recorded in medical records. Staff recording falls were likely to be aware of allocation status. Researchers examining records were blinded to allocation status |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Judgement comment: ITT analysis |
| Selective reporting (reporting bias) |
Low risk |
Judgement comment: falls, fallers, injurious falls, fracture falls and falls incidence reported |
| Method of ascertaining falls |
High risk |
Judgement comment: no falls definition reported |
| Baseline imbalance |
Low risk |
Judgement comment: groups balanced at baseline |
| Other bias |
Low risk |
Judgement comment: none identified |
