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Table 1 Inclusion/exclusion criteria

From: Preliminary effect and feasibility of physiotherapy with strength training and protein-rich nutritional supplement in combination with anabolic steroids in cross-continuum rehabilitation of patients with hip fracture: protocol for a blinded randomized controlled pilot trial (HIP-SAP1 trial)

Inclusion criteria

• Patients who have undergone surgery for a hip fracture at Amager-Hvidovre University Hospital and admitted to the Hip Fracture Unit at the hospital

• Age ≥ 60 years

• Ability to speak and understand Danish and having a Danish Social Security number

• Able to give written informed consent

• Residing at home and with an independent prefracture indoor walking ability (New Mobility Score ≥ 2)

Exclusion criteria

• Postoperative weight-bearing restrictions

• Multiple fractures

• Active cancer or suspected pathological fracture

• Patient unable/unwilling to cooperate for testing and rehabilitation

• Planned/elective hospitalization within the trial period

• Cognitive dysfunction determined by chart review, reported by nursing staff, or observed by trained research staff (disoriented, dementia, active delirium)

• Uncontrolled blood pressure (systolic > 150 mmHg or diastolic > 100 mmHg)

• Heart disease in the form of peri-, myo-, or endocarditis

• History of stroke with motor disability

• Heart failure (New York Heart Association class III and IV)

• Evidence of kidney failure or renal impairment (estimated glomerular filtration rate < 30 ml/min/1.73 m2 or serum creatinine > 200 μmol/L)

• Abnormal liver function tests (alanine aminotransferase, γ-glutamyltransferase, bilirubin, or alkaline phosphatase > 2 times the upper limit of normal) or history of hepatic tumor

• Elevated hematocrit ≥ 50%

• History of breast or prostate cancer

• Abnormally elevated serum prostate-specific antigen (PSA) assessed at the 3-week control* corresponding to PSA < 4.0 μg/L (60–70 years), PSA < 5.0 μg/L (> 70 years)

• Allergic to any ingredient in the Deca-Durabolin solution (nandrolone, benzyl alcohol, arachis oil [peanut oil], and allergy to peanuts or soya) or milk protein allergy (related to the nutritional drink)

  1. *PSA during admission could be increased due to catheterization; therefore, PSA will be assessed at 3 weeks, and patients will be excluded at this time point if elevated values are identified