Nelson 2004.
| Methods | Type of Study: RCT. | |
| Participants | Number of participants randomised: 72
Losses: 2 from control group N = 72 Age: over 70 years Sex: 27 women Health status defined by authors: healthy Residential status of participants: community dwelling Setting: USA Inclusion: > 70 exercising no more than 1 day/week community dwelling must have 2 functional limitations and score 10 or less on EPESE. Exclusion: Unstable cardiovascular disease, psychiatric disorders, neurological or muscular diseases, terminal illness, cognitive impairment. |
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| Interventions | EXERCISE GROUP (MULTIPLE): (N = 34) balance and strength using free weights working at 7/8 on a 10 point Borg Scale, tandem walks, running etc, plus 120 minutes physical activity per week CONTROL GROUP: (N = 38) attention via nutritional education booklet. Duration and intensity: exercise programme ‐ 3 times a week for 6 months plus 120 minutes physical activity per week. Supervisor: exercise physiologist Supervision: exercise group ‐ individual self paced, 6 home visits in the 1st month and then monthly, attention control ‐ 2 home visits in 1st month and then monthly. Setting: home. | |
| Outcomes | Tandem walk (over 20 feet) (s).
Single legged stance (max 30 s).
Maximum gait speed (over 2 m) Compliance/adherence: mean 82%. Adverse events 1 fell in exercise group and 1 food poisoning in control group. |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Stratified block randomisation by gender and age (70 to 79 and 80+) |
| Allocation concealment (selection bias) | Low risk | Yes, adequately |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Withdrawals described analysis not possible |
| Selective reporting (reporting bias) | Low risk | Main outcome measures described |
| Other bias | Unclear risk | The study appears to be free of other sources of bias |
| Blinding (participant) | High risk | Not possible |
| Blinding (assessor) | Low risk | Assessors 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 |