Stasi 2019.
Study characteristics | ||
Methods | Randomised controlled trial. Stratified by gender and age | |
Participants | Inpatient orthopaedic ward of KAT General Hospital of Attica, Athens, Greece (for 1 week), then participants' homes Period of study: recruitment April 2012 to May 2016 100 participants Inclusion: diagnosis of displaced femoral neck fracture (Garden's classification III or ΙV), aged between 70 and 84 years, with community‐dwelling status before hip fracture, not having undergone previous orthopaedic surgery on the fractured or the contralateral hip, body mass index between 19 and 35 kg/m2, able to walk outdoors for 2 neighbourhood blocks before fracture Exclusion: nil Age: mean (SD) 77.5 (4.2) % male: 25 Number lost to follow‐up: 4 | |
Interventions | 1. Intervention: Weeks 1 to 3, intervention the same in both groups. From week 4, addition of intensive exercise programme to control programme, emphasising hip abductor strengthening of affected limb. Hip abductor strength training in standing and side‐lying positions, resistance progressed with cuff weights and loop elastic bands, 2 sets of 10 reps, progressing to 3 sets of 15 reps. Home sessions initially 40 minutes, increasing to approx. 55 minutes. 2. Control: 'Standard Physiotherapy', a 12‐week standard physiotherapy programme, initiated on the 2nd postoperative day, continuing for 1 week in hospital and 11 weeks at home. Physiotherapist delivered individualised programme daily in hospital and 3x/week at home, with participants instructed to do programme independently on other days. Programme included progressive functional movements, range of motion, gait training, strengthening (progressing to loop elastic bands). Home sessions initially 30 minutes, increasing to maximum of 45 minutes. Difference between groups: intervention group had approx. 10 minutes extra per physio session. Isotonic hip abductor strengthening commenced week 4 (intervention group), 6 (control group). Resistance added earlier in intervention group. At end of 12‐week intervention, both groups encouraged to continue exercise programme 3x/week for 3 months. |
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Outcomes | 12 weeks and 24 weeks. Hip abductor strength, dynamometer Timed Up and Go test Lower Extremity Functional Scale‐Greek version Falls Use of walking aid |
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Notes | Trial registered ISRCTN30713542 The study states results are reported as mean (SD). During analysis, we noted the study was an outlier for all outcomes. If we assumed standard error was reported instead of standard deviation, then converted standard error to standard deviation, the results were consistent with other studies. We used the converted data in the review’s analyses. In this study the difference in intervention between groups occurs at home. 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 | Quote: "Randomization..was performed by an independent clinician according to the randomization list". "Sex and age were used as stratification factors in the randomization process. The sex ratio was 3/1 (3 females to 1 male). The age ratio was 1/1/1 (three age sub‐groups), equally spaced using block size 4. The study’s randomization list was formed on the basis of these principles." |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No mention of blinding of therapists and participants; impact of this on results is unclear |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, some judgement | Low risk | Quote: "All assessments were carried out by the same examiner, who was not involved in any way with the rehabilitation program and was blinded with respect to the group assignment". |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Low risk | Unlikely to be affected by bias |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | Low risk | Less than 20% of data lost to follow‐up |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | Low risk | Less than 20% of data lost to follow‐up |
Selective reporting (reporting bias) | Low risk | All outcome measures listed in trial registration are reported |
Free from baseline imbalance bias? | Low risk | Appears balanced for reported outcomes. Note baseline values not presented for physical measures |
Free from performance bias due to non‐trial interventions? | Low risk | Both groups received physiotherapy intervention 3x/week at home |