Mitchell 2001.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Geriatric Orthopaedic Unit (Lightburn Hospital) connected with Glasgow Royal Infirmary, UK Period of study: February 1997 to August 1998 80 participants Inclusion: people aged ≥ 65 years with hip fracture treated surgically, written informed consent Exclusion: abbreviated mental score < 6/10, previously unable to walk, medically unstable Age: mean 80 years (range not stated) % male: 16% Number lost to follow‐up: 16 (refused or unavailable); also, 7 died and 13 with new comorbidity precluding assessment were not included in final analyses. | |
Interventions | Early postoperative rehabilitation 1. Twice weekly quadriceps strengthening exercises in both legs for 6 weeks whilst a hospital inpatient on a rehabilitation ward. Sessions involved 6 sets of 12 repetitions of knee extension (both legs), progressing from 50% of participant's 1 RM (weeks 1 and 2), 70% (weeks 3 and 4) and up to 80% (weeks 5 and 6). Participant’s 1 RM (maximum load an individual can lift through full range of knee extension) established initially and at 3 and 5 weeks. Plus usual care. versus 2. Usual care only. Consisted of conventional physiotherapy for approximately 20 minutes per day, 5 days a week. Initial bed exercises, progressing to bed and chair transfers, gait re‐education and balance training, to practice of functional activities in gym including use of parallel bars. Participants transferred to a rehabilitation unit at about 15 days (median 15 versus 16 days) after surgery for a hip fracture. | |
Outcomes | Length of follow‐up: 6 weeks and 16 weeks (16 weeks used in analysis) Elderly mobility scale Leg extension power Walking velocity Barthel Index 'Get up and go' test Functional reach Length of hospital stay Mortality |
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Notes | Measured adherence Funding: none declared Conflict of interest: nil |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomisation was performed using computer‐generated random numbers" |
Allocation concealment (selection bias) | Low risk | "[Group] allocation for each study patient concealed in a sealed envelope and held by a third party who was not otherwise involved in the study" |
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 | “Recordings were made by a single research assistant who was not blinded to study group allocation.” While “an independent blinded assessor performed repeat measurements of leg extensor in a convenience sample of 18” participants at 6 weeks plus 2 days gave reassuring results, this was not considered an adequate protection against bias. |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Low risk | Blinding unclear; however, mortality outcome is usually unlikely to be influenced by knowledge of group allocation. |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | High risk | Bias could have occurred given the high loss to follow‐up at 16 weeks (intervention: 50% versus control: 40%). |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | High risk | Bias could have occurred given the high loss to follow‐up at 16 weeks (intervention: 50% versus control: 40%). |
Selective reporting (reporting bias) | Low risk | Comprehensive report of outcome including consistent primary outcome |
Free from baseline imbalance bias? | Low risk | In all key characteristics |
Free from performance bias due to non‐trial interventions? | Low risk | Care other than the trial interventions appears comparable in the 2 groups. |