Ohoka 2015.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Matterhorn Rehabilitation Hospital, Kure, Japan Period of study: not reported 27 participants Inclusion: proximal femoral fracture, surgical management, 90 years of age or older Exclusion: conservative treatment Age: mean 90.2 years (range: 90 to 93, SD 1.4) % male: 0 Number lost to follow‐up: 14 (7 withdrew, 2 excluded, 5 lost to final follow‐up) |
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Interventions | Additional exercise: treadmill training in addition to standard physiotherapy 1. Body weight‐supported treadmill training for 10 minutes, 4 times per week in addition to standard physical therapy 4 times a week versus 2. Usual care. No body weight‐supported treadmill training. Standard physical therapy 6 times a week for 40 minutes a day |
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Outcomes | Follow‐up: at discharge (mean (SD) length of stay in intervention group = 84 (8.6) days, control 77.8 (5.5) days. Therefore, used 81 days (12 weeks) for follow‐up. Gait speed: 10m walking time Strength: isometric knee extension Functional Independence Measure Length of stay Adverse events: surgical complications, re‐admission, persistent pain, falls |
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Notes | Published as conference abstract only. Author provided additional study details by email correspondence. Funding: none declared Conflict of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Reported as 'simple randomisation' in correspondence with author |
Allocation concealment (selection bias) | Low risk | Author correspondence: ‘central randomisation’ |
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 | Author reported 'single blind test' |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Low risk | Author reported 'single blind test'. Unclear whether researchers ascertaining surgical complications and re‐admission were blinded. Assessment of these outcomes is usually unlikely to be influenced by knowledge of group allocation. |
Blinding of outcome assessment (detection bias) Participant/proxy‐reported outcomes | Unclear risk | Insufficient information for assessment |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | High risk | Large loss to follow‐up (52%) |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | High risk | Large loss to follow‐up (52%) |
Incomplete outcome data (attrition bias) Participant/proxy‐reported outcomes | High risk | Large loss to follow‐up (52%) |
Selective reporting (reporting bias) | Unclear risk | No trial registration or protocol identified |
Free from baseline imbalance bias? | Unclear risk | Not clearly reported (baseline mobility not available) |
Free from performance bias due to non‐trial interventions? | High risk | Time spent in training sessions appears to be different between groups |
Method of ascertaining falls | Unclear risk | Not reported |