Sherrington 2004.
Study characteristics | ||
Methods | Randomised trial: use of random numbers, balanced within blocks of 6 participants. Use of sealed opaque numbered envelopes | |
Participants | Community‐dwellers and residents of aged‐care facilities discharged from 6 hospitals in Sydney, Australia Period of study: April 1998 to June 2000 120 participants Inclusion: people who had completed usual care after a fall‐related hip fracture; consent Exclusion: unable to complete assessment and participate in exercise programme due to a) severe cognitive impairment, b) medical conditions, or c) complications from fracture resulting in delayed healing and associated weight‐bearing restrictions. Age: mean 79 years (range 57 to 95 years) % male: 20 Number lost to follow‐up: 12 (7 withdrew consent ‐ refused assessment; 5 died) | |
Interventions | All participants had a preliminary assessment which took place, on average, 22 weeks after their injury.
1. Home‐based, weight‐bearing exercises (weight‐bearing position with support as required). Exercises were sit‐to‐stand, lateral step‐up, forward step‐up‐and‐over, forward foot taps, and a stepping grid. Exercises initially conducted with tables, chairs or walking aids used for support. Exercises progressed by increasing the number of repetitions, lessening the hand support, increasing the height of blocks, decreasing height of surface from which the participant was standing up, etc.
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2. Home‐based, non‐weight‐bearing exercises (performed in the supine position) prescribed by a physiotherapist. Exercises were hip abduction, hip flexion, hip/knee flexion/extension, end of range knee extension, ankle dorsiflexion/plantarflexion. Exercises were progressed by increasing the number of repetitions undertaken.
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3. Control (no specific instructions) For both exercise groups, the prescribing physiotherapist chose several initial exercises and number of repetitions in keeping with the participant's capability. Individuals in the weight‐bearing group were provided with stepping block(s). Participants were advised on progression. Line drawings of the exercises were provided and they were checked at 1 week. Further assessment and prescription at 1 and 4 months. Participants also asked to keep a record of their exercises. Exercises were prescribed for 4 months minimum. Advice for exercises etc. given to each participant as deemed appropriate by the physiotherapist conducting final assessment at 4 months. |
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Outcomes | Length of follow‐up: 4 months Walking ability/mobility Gait: walking velocity, step length Strength: hip abduction and flexion and knee extension Balance: step test, sway and functional reach Functional performance measures: timed sit‐to‐stand, supine‐to‐sit and Physical Performance and Mobility Examination Mortality Subjectively‐assessed: risk of falling, balance, pain, sleep quality, health Compliance and assessment of exercises (intervention groups only) Falls |
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Notes | Trial was performed as part of Cathie Sherrington's PhD work Additional information, including binary data for mobility and subjective outcomes, received 09 February 2004. Funding: Health Research Foundation Sydney South West, Arthritis Foundation of Australia, and National Health and Medical Research Council Partnership in Injury Grant. Conflict of interest: nil |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The randomization schedule was produced with a random number table, with subjects being randomized to groups in blocks of 6." |
Allocation concealment (selection bias) | Low risk | "..subjects were allocated to groups using assignments sealed in opaque envelopes." Clarification of method by personal communication: "Group allocation enclosed in sealed opaque envelopes which were numbered by subject number which was allocated when the consent form was signed." |
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 | Assessors were not blinded. However, there was training with the aim of standardisation between the 3 testers. |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Unclear risk | Not blinded. Unlikely to be affected by the lack of blinding. |
Blinding of outcome assessment (detection bias) Participant/proxy‐reported outcomes | High risk | Assessors were not blinded |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | Low risk | Intention‐to‐treat analysis was done and a participant flow diagram provided. Though percentages were presented in the trial report, full data were provided by contact with the lead trialist. |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | Low risk | Intention‐to‐treat analysis was done and a participant flow diagram provided |
Incomplete outcome data (attrition bias) Participant/proxy‐reported outcomes | Low risk | Intention‐to‐treat analysis was done and a participant flow diagram provided. Though percentages were presented in the trial report, full data were provided by contact with the lead trialist. |
Selective reporting (reporting bias) | Unclear risk | Bias unlikely but protocol not available. |
Free from baseline imbalance bias? | Low risk | Visual inspection of the table of baseline characteristics was consistent with the claim in the report of there being no clinically important or statistically significant differences between the 3 study groups at the initial assessment. |
Free from performance bias due to non‐trial interventions? | Low risk | A systematic approach was taken. |