Latham 2003.
| Methods | Type of study:RCT | |
| Participants | Number of participants randomised: 243 Losses:21 Age: 79.1 ‐/+ 6.9 Sex: 129 women, 114M Health status as defined by authors: frail Residential status of participants: mixed ‐ inpatient and outpatient Setting: New Zealand and Australia Inclusion: aged 65 or over; frail; no clear indication or contraindication to either of the study treatments Exclusion: not trial; treatment considered potentially hazardous; poor prognosis i.e. unlikely to survive 6 months; severe cognitive impairment; scores less than 20 on a 30 point MMSE; physical limitations that could limit adherence to the exercise program; not fluent in English |
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| Interventions | EXERCISE GROUP (STRENGTH): high intensity quadriceps exercise program using adjustable ankle cuff weights ‐ (warm‐up stretches followed by knee extension repetitions CONTROL GROUP: telephone calls or visits where general health discussed and advice re recovery/problems Duration and intensity: three times per week over 10 weeks Supervisor: experienced physiotherapist Supervision: weekly phone call or visit Setting: first two sessions in hospital and then at home | |
| Outcomes | Berg Balance Scale (0 to 56 scale) TUG (s) Time taken to walk 4 metres (s) Compliance/Adherence: 82% of prescribed exercise sessions (mean 24.6 of 30 sessions) Adverse events: not reported |
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| Notes | Insufficient data presented for meta‐analysis (non‐parametric data presented). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer central randomisation scheme ‐ stratified block |
| Allocation concealment (selection bias) | Low risk | Only biostatistician aware of allocation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis ‐ withdrawals described and accounted for |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
| Other bias | Low risk | The study appears to be free of other sources of bias |
| 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 | Follow‐up 6 months post randomisation i.e. approximately 3 or 4 months after the 10 week exercise intervention. |