Sylliaas 2011.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Outpatient clinic, recruited from Ullevål University Hospital or Diakonhjemmet Hospital in Oslo, Norway. Period of study: June 2007 and June 2009 150 participants Inclusion: femoral neck fracture or a trochanteric fracture; 12 weeks after the operation: (i) age 65 years or older; (ii) living at home; (iii) able to undergo physical therapy for the hip fracture; and (iv) scoring 23 or more (out of 30) on the Mini Mental State Examination Age: mean (SD) 82.4 (5.7) % male: 17 Number lost to follow‐up: 12 |
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Interventions | 1. Intervention: 3 to 6 months after fracture: physiotherapist‐led programme, exercise class 2x/week and home programme at least once/week. 45‐ to 60‐minute exercise session, 15‐minute warm‐up on cycle or treadmill; 4 exercises (standing knee flexion, lunge, sitting knee extension and leg extension, with 3 sets of 15 reps at 70% of 1 RM, increasing to 8 to 10 reps at 80% of 1 RM at 3 weeks. Encouraged to walk approx. 30 minutes/day. 2. Control: participants were asked to maintain their current lifestyle. No restrictions were placed on their exercise activities. |
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Outcomes | 12 weeks: 6‐Minute Walk Test Berg Balance Scale Sit to stand x10 Timed Up and Go test Gait speed Maximum step height Nottingham Extended Activities of Daily Living scale Short Form‐12 mental and physical domains |
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Notes | Funding: Eastern Regional Health Authority 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 "patients were assigned randomly by a computer‐generated list" |
Allocation concealment (selection bias) | Low risk | Quote "using lots in sealed 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 | Assessor blinded to group allocation |
Blinding of outcome assessment (detection bias) Participant/proxy‐reported outcomes | Unclear risk | Assessor blinded to group allocation |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | Low risk | Adequate follow‐up and ITT analysis. Less than 20% of data missing |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | Low risk | Adequate follow‐up and ITT analysis. Less than 20% of data missing |
Incomplete outcome data (attrition bias) Participant/proxy‐reported outcomes | Low risk | Adequate follow‐up and ITT analysis. Less than 20% of data missing |
Selective reporting (reporting bias) | Unclear risk | No trial protocol identified |
Free from baseline imbalance bias? | Low risk | Groups balanced at baseline |
Free from performance bias due to non‐trial interventions? | High risk | Social contact in intervention arm likely to confound any effect. An appropriate comparator would have been social home visits but no physical intervention. |