Preliminary effect and safety of physiotherapy with strength training and protein-dense nutritional supplement in combination with anabolic steroids in cross-continuum rehabilitation of patients with hip fracture - a randomized controlled pilot trial. (The HIP-SAP trial) - HIP-SAP trial

Morten Tange Kristensen/Hvidovre Hospital0 个研究点目标入组 48 人开始时间: 2018年2月1日最近更新: 2020年7月27日

适应症

试验速览

暂无简介。

•Patients who have undergone surgery for a hip fracture at Amager-Hvidovre University Hospital and admitted at the Hip Fracture Unit at the hospital
•Age >=65 years
•Ability to speak and understand Danish and with a Danish Social Security Number
•Able to give written informed consent
•Residing at home and with an independent pre-fracture indoor walking ability (NMS=2)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 48

•Postoperative weight-bearing restrictions
•Multiple fractures
•Terminal illness
•Patients unable/unwilling to cooperate on 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 (not alert or oriented, 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 (NYHA class III and IV)
•Evidence of kidney failure or renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m2 or serum creatinine >200µmol/L)
•Abnormal liver function tests (alanine aminotransferase, ?-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 PSA 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).

发起方

Morten Tange Kristensen/Hvidovre Hospital