Baum 2003.
Methods | Type of study: Cross over trial, crossed over at 6/12 | |
Participants | Number of participants randomised: 20 Losses: not reported N = 20 Age: mean 88 years Sex: 82% women, 12% men. Health status as defined by authors:not reported Residential status of participants: institutional dwelling, long term facility Setting: USA Inclusion: > 65 living in the facility for more than 3/12, able to ambulate with device or one person Exclusion:acute unstable illness, chronic illness, unable to follow 2 step command, assaultive behaviour pattern, unwillingness to discontinue existing therapy |
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Interventions | EXERCISE GROUP (STRENGTH): n = 11 strength and flexibility training, ankle and wrist weights, theraband CONTROL GROUP: n = 9 recreational activity, drawing and painting, puzzles, cards Duration and intensity: 1 hr 3 x per week for 6/12 Supervisor: exercise physiologist and trained staff Supervision:group Setting: institution (home) | |
Outcomes | Berg balance scale (0 to 56 points) TUG (s) Physical Performance Test (7 point scale) Compliance/Adherence: at exercise group 80%, recreational group 56% Adverse events: not reported |
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Notes | Data not reported appropriately for analysis purposes. (Our approach for cross‐over RCTs, data for the initial periods were included but it was deemed inappropriate (due to potential long lasting effects of the intervention) for the crossover data to be included.) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers supplied in sequence by co‐ordinator |
Allocation concealment (selection bias) | Low risk | Sealed envelopes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis performed |
Selective reporting (reporting bias) | High 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 | Cross over study |
Blinding (assessor) | Low risk | Assessors blind to group allocation |
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 |