Taraldsen 2019.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Hospital in central Norway Period of study: February 2011 to March 2014 143 participants Inclusion: community‐dwelling in Trondheim municipality prior to the fracture, 70 years or older, diagnosed and operated for intracapsular or extracapsular hip fractures and identified by experienced physiotherapists by use of hospital admission lists. Exclusion: pathological fracture, less than 3 months' life expectancy, inability to walk 10 m (with or without walking aids) before the fracture, or participating in conflicting research project; at 4 months, participants were also excluded after a medical examination if they had contraindications for training (unstable medical conditions) or were bedridden Age: mean (SD) 83.4 (6.1) % of male: 31 Number lost to follow‐up: 20 |
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Interventions | Additional home‐based exercise programme delivered 4 months following hip fracture in additional to usual rehabilitation and health care services 1. Received 2 exercise sessions a week for 10 weeks from physiotherapists at home. The programme targeted balance and gait and consisted of 5 individually‐tailored, weight‐bearing exercises, all entailing change in base of support: walking, stepping in a grid pattern, stepping up on a box, sit‐to‐stand, and lunge. Each exercise was described at 5 levels with increasing challenge. 2. Usual care |
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Outcomes | End of intervention = 2 months. Outcomes also at 8 months. Short Physical Performance Battery Gait speed Barthel Index Nottingham Extended Independent ADL EuroQol 5D‐3L Need for walking aid / assistance Number of people who fell Cost‐effectiveness |
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Notes | Funding: Norwegian Women’s Health Association and the Norwegian Extra Foundation for Health and Rehabilitation through the EXTRA funds, the Norwegian Fund for Postgraduate Training in Physiotherapy, and the Liaison Committee between the Central Norway Regional Health Authority (RHA), Trondheim Municipality, and the Norwegian University of Science and Technology (NTNU). 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: "The randomization was performed using a web‐based computerized randomization service... A stratified block randomization technique was used to ensure balanced group concerning intra‐capsular versus extra‐capsular fractures and pre‐fracture use of walking aid (rollator indoor or not)." |
Allocation concealment (selection bias) | Low risk | Randomisation performed off‐site using a web‐based computerised randomisation service |
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 | "Assessors and personnel performing statistical analyses were blinded to participants’ group allocation." Participants were instructed not to provide information that could reveal group allocation to the researchers and assessors, and this information was repeated prior to each assessment. |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Unclear risk | Method of ascertainment of death unclear |
Blinding of outcome assessment (detection bias) Participant/proxy‐reported outcomes | Unclear risk | Health‐related quality of life: blinded assessors Falls reported in retrospect by participants and staff who were aware of group allocation; therefore, high risk of bias for falls |
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 |
Incomplete outcome data (attrition bias) Participant/proxy‐reported outcomes | Low risk | Less than 20% of data lost to follow‐up |
Selective reporting (reporting bias) | Unclear risk | TUG and strength are in protocol but were not measured on frailer participants "due to burden on the participants." Therefore, these measures were not reported in the results. This seems an adequate explanation and the majority of prespecified outcomes were measured. |
Free from baseline imbalance bias? | Unclear risk | Intervention group more likely to live alone; mobility measures were balanced |
Free from performance bias due to non‐trial interventions? | High risk | No control for social interaction effect, with 2x weekly physio visits in home and a high proportion of participants living alone |
Method of ascertaining falls | Unclear risk | Number of new falls during the 12‐month follow‐up period was registered based on retrospective report |