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. 2022 Sep 7;2022(9):CD001704. doi: 10.1002/14651858.CD001704.pub5

Kronborg 2017.

Study characteristics
Methods Randomised trial (randomisation was stratified for fracture type (trochanteric/femoral neck))
Participants Acute orthopaedic ward at a university hospital, Copenhagen, Denmark
Period of study: October 2013 to May 2015
90 participants
Inclusion: home‐dwelling, primary hip fracture surgery, aged 65 years or older, able to speak and understand the Danish language, independent pre‐fracture indoor walking ability equal to a New Mobility Score ≥ 2
Exclusion: multiple fractures, weight‐bearing restrictions, people unwilling to participate in appropriate rehabilitation or unable to co‐operate in tests, terminal illness, and treatment with total hip arthroplasty or parallel pins
Age: mean (SD) 79.6 (7.56)
% male: 23
Number lost to follow‐up: 10 (restrictions after X‐ray n = 1, re‐fracture n = 1, discharge without notice n = 2, declined assessment n = 1, death n = 2, transferred n = 2, incomplete follow‐up test of fractured limb n = 1)
Interventions 1. Intervention: routine physiotherapy* plus additional daily individual progressive knee‐extension strength training with 3 sets of 10 repetitions performed with an intensity of 10 repetition maximum (10 RM), defined as ±2 RM of the fractured limb using ankle weight cuffs.
2. Control: routine physiotherapy*
*Routine physiotherapy: basic mobility and exercise therapy primarily aimed at lower extremities following a guideline with 12 specific lower limb exercises, progressed individually and conducted daily on weekdays with 1 to 2 contacts per day (weekends included postoperative day 1 to 3 only). Repetitions and intensity were not standardised. Also basic mobility activities, balance and stair climbing aimed at regaining physical function corresponding with levels of pre‐fracture habitual activity, and progression of walking aids.
Outcomes Change in maximal isometric knee‐extension strength (N·m/kg) in the fractured limb in percentage of non‐fractured limb (Maximal Voluntary Torque per kilo body mass) from inclusion to postoperative day 10 or discharge (follow‐up), using belt‐fixed handheld dynamometer
Timed Up and Go test, measured as early as possible after surgery when participant could walk independently with rollator and at follow‐up using a rollator as a standardised walking aid
Independent mobility at discharge (scored using Cumulated Ambulation Score)
Length of admission (postoperative day of discharge)
Discharge destination
Pain. Hip‐fracture‐related pain at rest and during outcome assessment, evaluated by Verbal Ranking Scale (score 0 to 4) using the highest pain level reported from each session
Death
Notes The stratification on fracture type was violated in the last 10 included participants due to slow inclusion of participants with a femoral neck fracture, allowing more participants with trochanteric fractures (n = 52) to enter the study compared to femoral neck fractures (n = 38). Measured gait speed and independent mobility, but no data presented.
Measured adherence
Funding: grants from The IMK Foundation (LK), The Research Foundation of the Capital Region (MTK), The Research Foundation of the Danish Physical Therapy
Conflict of interest: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "[Randomly] allocated to two different postoperative in‐hospital rehabilitation interventions by a neutral person (blinded to outcomes and patient characteristics) via a computer‐generated list"
Allocation concealment (selection bias) Low risk "[Notes] placed in sealed envelopes and marked with participant numbers only"
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 Outcome assessor was blinded to group assignment.
Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement Unclear risk Method of assessing death was unclear.
Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement Unclear risk Timed Up and Go test and timed 10 m walk were performed only for people who could walk;unclear what percentage of participants contributed to these measures
Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home Low risk 10/90 (11%) lost to follow‐up
Selective reporting (reporting bias) High risk Protocol appended to paper. Thigh and lower leg circumference is an outcome in protocol, but not reported. Protocol states Timed Up and Go test, 10‐Metre Walk Test, New Mobility Score, and isometric strength would be assessed at 16 weeks, but these were not reported in results paper. Data not presented for 10m walk time, but between‐group difference is reported.
Free from baseline imbalance bias? Low risk No imbalance noted
Free from performance bias due to non‐trial interventions? Low risk Care and experience of care providers appears consistent across groups