Oh 2020.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Department of Rehabilitation Medicine at a university hospital, South Korea
Period of study: September 2017 to April 2019
45 participants
Inclusion: men and women aged 65 to 90 years old who underwent surgery for femoral neck (intertrochanteric or subtrochanteric) fracture and had sarcopenia (diagnosed as low muscle mass combined with low muscle strength (handgrip strength) and/or low physical performance) Exclusion: (i) hip surgery for infection, arthritis, implant loosening, or avascular necrosis; (ii) femoral shaft fracture, acetabular fracture, isolated fracture of the greater or lesser tuberosity, or periprosthetic fracture; (iii) pathologic fracture; (iv) combined multiple fracture; (v) revision surgery; and (vi) severe cognitive dysfunction (obey command ≤ 1 step). Refusal to participate in a clinical trial Age: mean 79 years (range: not stated) % male: 32 Number lost to follow‐up: 7 (2 withdrew consent; 3 lost to follow‐up; 2 died) |
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Interventions | Control: standardised rehabilitation treatment, 30 minutes/day each of 10 consecutive working days. Physiotherapist delivered passive hip and knee mobilisation, strengthening of the hip abductor and extensor muscles, transfer and gait training on the floor and stairs during every session. Plus 20 minutes of lower limb exercises in supine position. Intervention: standardised rehabilitation treatment as above, identical to control group. Plus antigravity treadmill (AGT) for 20 minutes/day for each of 10 consecutive working days. Days 1 to 5 AGT was applied with 50% to 60% of body weight administered at a rate of 1.5 miles per hour. Days 6 to 10 AGT was applied with 70% to 80% of body weight administered at a rate of 1.5 to 1.8 miles per hour. |
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Outcomes | Baseline, 3 weeks, 3 months, 6 months Koval walking ability score Functional ambulatory category Berg Balance Scale EuroQol‐5D Korean version of the modified Barthel Index Hand grip strength |
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Notes | 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 | Computer‐generated randomisation lists generated by statistician not involved in the intervention |
Allocation concealment (selection bias) | Low risk | Sealed, opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Therapists who provided the rehabilitation programme and the participants were not blinded to group. The effect on bias is unclear. |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, some judgement | Low risk | Researchers conducting outcome measurements were blinded to group. |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Low risk | Unclear whether researchers ascertaining mortality were blinded. Assessment of mortality outcome is usually unlikely to be influenced by knowledge of group allocation. |
Blinding of outcome assessment (detection bias) Participant/proxy‐reported outcomes | Unclear risk | Researchers conducting outcome measurements were blinded to group. |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | Unclear risk | 16% loss to follow‐up |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | Unclear risk | 16% loss to follow‐up |
Incomplete outcome data (attrition bias) Participant/proxy‐reported outcomes | Unclear risk | 16% loss to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Trial registered prospectively; however, not translated from Korean for assessment at time of publication. May change to 'low risk' after assessment of trial registration |
Free from baseline imbalance bias? | Unclear risk | Difference in type of surgery between groups (intervention group had 9 hemiarthroplasty, 9 open reduction and internal fixation (ORIF), 1 total hip joint replacement; control group had 17 hemiarthroplasty, 2 ORIF). Potential effect of this on outcome is unclear |
Free from performance bias due to non‐trial interventions? | Low risk | Time in training and staff involved were the same in both groups |