Miller 2006.

Study characteristics
Methods	Randomised controlled trial
Participants	Orthopaedic wards of Flinders Medical Centre, Adelaide, Australia Period of study: recruitment September 2000 to October 2002 63 hip fracture patients (out of a total of 75 participants with fall‐related lower limb fracture) Inclusion: age 70 years or over, fall‐related lower limb fracture, resident in Southern Adelaide, malnourished ( < 25thpercentile for mid‐arm circumference for older Australians), written consent by patient or next of kin. Exclusion: unable to understand instructions for positioning of upper arm, could not full weight bear on side of injury > 7 days post admission, not independently mobile pre‐fracture, medically unstable > 7 days post admission, cancer, chronic renal failure, unstable angina, diabetes. Age (of 75): mean 83.5 years % male (of 75): 23 Number lost to follow‐up: 5 (3 dead at 12 weeks and 2 withdrew)
Interventions	Early postoperative rehabilitation. Intervention started from 7 days after fracture. 1. Resistance training supervised by a physiotherapist 3 times per week, 20 to 30 minutes per session, for 12 weeks. To ensure standardisation, the trial physiotherapists were instructed to deliver only the structured programme of therapy to participants. Programme incorporated progressive resistance training of the hip extensors and abductors (supine), knee extensors (supine or sitting) and ankle dorsi‐ and plantar‐flexors (supine or sitting). Training was increased as soon as 2 sets of 8 repetitions of the exercise could be completed in good form, judged by physiotherapist. versus 2. Resistance training plus nutrition: Fortisip (Nutricia Australia Pty Ltd) oral protein and energy supplement (1.5 kcal/mL, 16% protein, 35% fat, 49% carbohydrate) to provide 45% of estimated energy intakes. (Individually prescribed and delivered.) Four doses of equal volume given by nurses from drug trolley, continued after hospital discharge at twice per day or more. Once weekly visits on weeks 7 to 12. versus 3. Attention control. Usual care and general nutrition and exercise advice. Tri‐weekly visits on weeks 1 to 6, once weekly on weeks 7 to 12. Discussions during these visits were limited to general information (e.g. benefits of regular exercise and nutrient‐dense meals). All participants were encouraged to continue prescribed treatments. All participants received usual clinical care (including general nutrition and exercise advice, usual dietetic and physiotherapy care, transfer to residential care, rehabilitation facility or directly home).
Outcomes	Length of follow‐up: 12 weeks (mobility outcomes); 12 months (mortality and re‐admissions) Gait speed Quadriceps strength Quality of life (SF‐12 physical component score and mental component score) Hospital re‐admission Mortality (reported for hip fracture patients at 12 months. Three‐month time point not used as data reported for non‐hip fracture patients) Length of hospital stay (acute, rehabilitation, total)
Notes	Measured adherence Trial population also included 25 other participants (23 with hip fracture) who were allocated to the nutrition‐only intervention group. Data from this group are not included in this review. Of the 14 participants with other lower limb fractures: 6 were pelvic and 8 were of the femur, tibia or fibula. Further information on trial, including mortality data for hip fracture patients, provided to Alison Avenell by Maria Crotty for the nutrition supplementation review (Avenell 2010). Started in acute orthopaedic ward and continued after discharge home. Median length of stay (acute and rehab) = 24 days. Funding: NHMRC Public Health Postgraduate Research Scholarship, Flinders University‐Industry Collaborative Research Grant and Nutricia Australia Pty Ltd. Conflict of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Participants were randomized by using a stratified (admission accommodation: community or residential care), block randomization method (blocks of 12) following baseline assessment.” From summary data provided 25 July 2003: "computer generated table of random numbers"
Allocation concealment (selection bias)	Low risk	"The Pharmacy department maintained a computer generated allocation sequence in sealed opaque envelopes."
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Care providers and patients not blinded. Impact of non‐blinding unclear
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, some judgement	Low risk	"Research staff blinded to treatment allocation performed outcome assessments (weight, quadriceps strength, gait speed, quality of life) 12 weeks after commencement of trial interventions."
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement	Unclear risk	Unclear whether research staff were blinded for these outcomes; however, mortality outcomes not likely to be influenced by knowledge of group allocation, uncertain for adverse events
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement	High risk	Denominators for gait analysis, quadriceps strength etc. not provided
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home	Unclear risk	Participant flow diagram provided (for 12 weeks), but inconsistent data provided at 1 year in a summary provided by trialists
Selective reporting (reporting bias)	Unclear risk	Protocol not available
Free from baseline imbalance bias?	Unclear risk	“No significant differences were identified across the four treatment groups.” However, twice as many cognitively‐impaired participants (17) in attention control group compared with combined intervention group (8); 12 in exercise group.
Free from performance bias due to non‐trial interventions?	Unclear risk	No information. More attention control group participants (11) were referred for dietetic intervention, as part of usual care, compared with exercise (6) and nutrition and exercise (5) groups.