Sherrington 1997.
Study characteristics | ||
Methods | Randomised trial: use of random numbers, balanced within blocks of 10 participants, to generate open list | |
Participants | South Western Sydney, Australia Period of study: December 1994 to December 1995 44 participants Inclusion: people aged 60 years or over with a fall‐related hip fracture who had lived in the community beforehand. Discharged from 1 of 4 acute hospitals to home or residential care within 9 months of their fracture. Contactable and consenting Exclusion: severe cognitive impairment or too ill or immobile to participate as judged by carers Age (of 42): mean 78.5 years (range 64 to 94 years) % male: 21 Number lost to follow‐up: 2 (withdrew consent); also 2 excluded at initial assessment. Also mentions: "One further person in the control group was not able to complete all the physical aspects of the assessment because of pain from a fall, later diagnosed as a further fracture." | |
Interventions | All participants had a preliminary interview and physical assessment lasting about 1 hour. This took place on average 7 months (5 to 9 months) after their injury.
1. Home‐based, weight‐bearing exercises for 1 month. Individuals in the intervention group were provided with stepping block(s) made of old telephone directories wrapped up with tape and shown the exercises by a physiotherapist. They were advised on how many stepping blocks and repetitions to do at least once daily at the start (these ranged from 5 to 50) and told to increase the repetitions gradually. A photograph was taken to help remind the participant of the correct method and they were checked at 1 week (4 to 16 days). Participants also kept a diary.
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2. Control (no specific instructions: usual care) Each telephone directory was 5 cm thick: approximately one‐third of a standard house step. |
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Outcomes | Length of follow‐up: 1 month (range 27 to 43 days) Quadriceps strength Sway and balance Functional reach Walking velocity Subjectively‐assessed balance |
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Notes | Measured adherence This trial was excluded in the versions of the review up to Issue 3, 2004 because participants were recruited 7 months after a hip fracture; this was previously outside the time period covered by this review, which then focused on early postoperative rehabilitation. Additional information obtained from Cathie Sherrington 09 Febrary 2004 and 24 March 2004 Funding: nil Conflict of interest: nil |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "[Randomly] allocated in order of contact using a random number method within groups of ten subjects." |
Allocation concealment (selection bias) | High risk | Trial investigator reported that "it was not concealed ‐ just a list of subject numbers and group allocation generated by a random number table; subjects were assigned to subject numbers in the order that contact was made with them." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Therapists conducting the intervention and participants were not blinded to the group assignment. Impact of non‐blinding is unclear. |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, some judgement | High risk | Not blinded |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Unclear risk | The few results are unlikely to be affected. |
Blinding of outcome assessment (detection bias) Participant/proxy‐reported outcomes | High risk | Not blinded |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | Unclear risk | The post‐randomisation exclusion of 2 participants meant that intention‐to‐treat analysis was not done. |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | Low risk | Few data but complete data provided on contact with trial investigator. |
Incomplete outcome data (attrition bias) Participant/proxy‐reported outcomes | Unclear risk | The post‐randomisation exclusion of 2 participants meant that intention‐to‐treat analysis was not done. |
Selective reporting (reporting bias) | Unclear risk | Bias unlikely but protocol not available. |
Free from baseline imbalance bias? | High risk | Statistically significantly more males in intervention group (8 versus 1). Males generally have poorer prognosis post hip fracture but also may have different baseline strength and attitude to exercises. |
Free from performance bias due to non‐trial interventions? | Unclear risk | There was a lack of information on care‐programme comparability. |