Lauridsen 2002.
Study characteristics | ||
Methods | Randomised trial: use of consecutively‐drawn, numbered, sealed, opaque envelopes | |
Participants | Rehabilitation Unit, Hvidovre Hospital, Copenhagen, Denmark Period of study: not stated 88 participants Inclusion: women aged 60 to 89 years transferred to a rehabilitation unit within 3 weeks after surgical treatment (osteosynthesis or partial hip replacement) of an "uncomplicated" hip fracture, full mobility prior to fracture, full weight bearing allowed, no concomitant disabling disorders, informed consent Exclusion: women who fell ill during the trial with symptoms that hindered training for more than 2 days; women discharged before attaining the planned functional capacity. (These appear to be post‐randomisation exclusion criteria.) Age: median 80 years (range 61 to 89 years) % male: none Number lost to follow‐up: none (37 dropouts still accounted for in analyses) | |
Interventions | Early postoperative rehabilitation
1. Participants were offered 6 hours per week of intensive physiotherapy, comprising 2 hours on Monday, Wednesday and Friday
versus
2. Standard physiotherapy of 15 to 30 minutes per weekday Qualitative content of the 2 programmes were identical: bench exercises, gait, balance, co‐ordination, stair climbing and, in some cases, hydrotherapy. Training was stopped when the planned functional capacity was attained unaided (walk 50 or more metres without resting in 2 minutes or less, using walking stick or quadruped if necessary; climb 1 flight of stairs; manage sit‐to‐stand transfer; move in and out of bed; manage bathing, dressing and lavatory visits) or when participants withdrew from study. |
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Outcomes | Length of follow‐up: until discharge from hospital Use of walking aids Orthopaedic complication Length of hospital stay Duration of training and length of training period Dropouts from training |
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Notes | Details of the method of randomisation provided on contact with lead trialist, but no other information gained. The current account of the trial is based on the report in the Danish Medical Bulletin. A colleague, Pernille Jensen, based in Denmark, checked through the paper written in Danish (in Ugeskr Laeger) and confirmed that, with the exception of a few small details, the English paper was a straight translation. Participants in the intervention arm spent significantly more total hours training and significantly more hours per day training than those in the control arm. Measured adherence Funding: none declared Conflict of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were randomised" |
Allocation concealment (selection bias) | Low risk | Letter from authors to Martyn Parker (06 August 2002): "numbered sealed opaque envelopes drawn consecutively" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "A blinded evaluation was performed by an external observer when the treating physiotherapist considered that the objective [attainment of functional capacity] had been obtained." However, this was after a non‐blinded person had assessed achievement of functional goals. |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, some judgement | High risk | "A blinded evaluation was performed by an external observer when the treating physiotherapist considered that the objective [attainment of functional capacity] had been obtained." However, this was after a non‐blinded person had assessed achievement of functional goals. |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Unclear risk | Blinding not specified. Unclear how assessment of adverse effects is influenced by potential knowledge of group allocation |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | Low risk | Data provided for all participants for intention‐to‐treat analysis as well as per‐protocol analysis |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | Low risk | Data provided for all participants for intention‐to‐treat analysis as well as per‐protocol analysis |
Selective reporting (reporting bias) | Unclear risk | Possible but no confirmation |
Free from baseline imbalance bias? | Low risk | Baseline comparability evident |
Free from performance bias due to non‐trial interventions? | Unclear risk | Incomplete assurance of comparability of other care provided to the 2 groups |