Moseley 2009.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Inpatient rehabilitation units of 3 teaching hospitals, Sydney, Australia Period of study: March 2002 to May 2005 160 participants Inclusion: people with surgical fixation for hip fracture admitted to the inpatient rehabilitation unit from the acute orthopaedic ward. Approval to weight bear or partial weight bear; able to tolerate the exercise programmes; able to take 4‐plus steps with a forearm support frame and the assistance of 1 person; no medical contraindications that would limit ability to exercise; living at home or low‐care residential facility prior to the hip fracture, with the plan to return to this accommodation at discharge. People with cognitive impairment were included if a carer who was able to supervise the exercise programme was available. Exclusion: high‐functioning patients discharged directly to home and low‐functioning patients discharged to a residential aged care facility from the acute orthopaedic ward. Patients with > 4 adjusted errors on the Short Portable Mental Status Questionnaire if no carer was available. Age: mean 84 years (range: not stated) % male: 19 Number lost to follow‐up: 10 (3 withdrew consent; 7 died) | |
Interventions | Postoperative rehabilitation, started after admission to inpatient rehabilitation unit. Continued at home post discharge.
1. Weight‐bearing exercise twice daily for a total of 60 minutes per day for 16 weeks. Five weight‐bearing exercises were prescribed in addition to walking on a treadmill with partial body weight support using a harness (for inpatients) or a walking programme (after hospital discharge). The 5 weight‐bearing exercises used for both legs included stepping in different directions, standing up and sitting down, tapping the foot and stepping onto and off a block. Hand support could be used if necessary. The exercises were progressed by reducing support from the hands, increasing block height, decreasing chair height and increasing the number of repetitions. This commenced as an inpatient programme, followed by home visits and a structured home exercise programme after inpatient discharge. The home exercise programme incorporated the 5 weight‐bearing exercises used in the inpatient phase, plus a walking programme. The frequency of home visits gradually decreased.
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2. Usual care (mainly non‐weight bearing exercise): participants undertook 5 exercises in sitting or lying position plus a small amount of walking using parallel bars or walking aids for a total of 30 minutes each day for 4 weeks. The exercises were progressed by increasing the repetitions and resistance. (This type of exercise programme is commonly prescribed after hip fracture). This commenced as an inpatient programme, followed by weekly home visits and a structured home exercise programme incorporating the same exercises. After 4 weeks, participants were provided with a tailored programme of limited weight‐bearing exercises for 12 weeks and encouraged to continue exercising; no further physiotherapy home visits were undertaken. "All participants received usual post‐operative mobilisation programme usually provided by other health professionals (e.g. occupational therapists) and any gait aids were progressed as per usual protocols. No other physiotherapy treatments were administered during the trial." |
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Outcomes | Follow‐up: 16 weeks Walking ability: able to walk unaided or with sticks Gait: walking velocity Strength: knee extension Balance: step test, sway and functional reach, lateral stability, coordinated stability test, choice stepping reaction time Physical Performance and Mobility Examination Sit‐to‐stand time Barthel Index Quality of life: EuroQol‐5D Pain (7‐point ordinal scale) Subjectively‐assessed outcomes (use of 5‐point Likert scales): current mobility, strength and balance Falls Accommodation in the community Use of community services Length of hospital stay Hospital re‐admission Mortality (stated as unrelated to trial protocol) Subjectively‐reported negative effects |
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Notes | Measured adherence Funding: National Health and Medical Research Council of Australia Conflict of interest: nil |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Participants were randomly allocated.... Randomisation was stratified for recruitment site and pre‐fracture Barthel Index (i.e. ≥80/100 or <80/100). The allocation sequence was generated from computer software..." |
Allocation concealment (selection bias) | Low risk | "The allocation sequence was .... concealed using consecutively numbered, sealed and opaque envelopes." |
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 | Low risk | "Measurements were made by assessors who were blinded to group allocation." |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Low risk | The assessment of mortality and re‐admission outcomes are usually unlikely to be influenced by knowledge of group allocation. |
Blinding of outcome assessment (detection bias) Participant/proxy‐reported outcomes | Unclear risk | Health‐related quality of life: blinded assessors Falls recorded by participants on falls calendar and assessors blinded. Impact of unblinded participant reporting of falls unclear |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | Unclear risk | Participant flow provided and full accounting of loss to follow‐up but differential loss to follow‐up (7 versus 3) could have made some difference |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | Unclear risk | Participant flow provided but aside from death, these outcomes not reported for whole groups |
Incomplete outcome data (attrition bias) Participant/proxy‐reported outcomes | Unclear risk | Participant flow provided and full accounting of loss to follow‐up but differential loss to follow‐up (7 versus 3) could have made some difference |
Selective reporting (reporting bias) | Low risk | Trial registration and consistently well‐reported trial |
Free from baseline imbalance bias? | Low risk | "There were no clinically important differences between the groups." Also evident from the presented data |
Free from performance bias due to non‐trial interventions? | Unclear risk | Possible; the trialists speculate that one reason for the general lack of differences between the two groups was that the therapists, who were not blinded to group allocation, may have modified the programme for participants in the control group. |
Method of ascertaining falls | Unclear risk | Falls were obtained using a falls calendar collected at 4‐week and 16‐week assessments and via a postal survey at 10 weeks. |