NCT03545347已完成2 期
Preliminary Effect and Safety of Physiotherapy With Strength Training and Protein-rich 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)
Morten Tange Kristensen PT, PhD1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2018年9月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in maximal isometric knee-extension strength (Nm/Kg) in the fractured limb.
研究概览
简要总结
This pilot trial investigates the preliminary effect and safety of a 12 week multi-modal intervention initiated during admission in the acute ward after hip fracture surgery. The intervention under investigation is a combination therapy consisting of physiotherapy, protein-rich nutritional supplement and nandrolone decanoate (Deca-Durabolin) supplement. The investigators expect the combination therapy to be a preliminary effective and safe treatment in elderly patients with hip fracture and that this combination therapy intervention program is more efficacious in improving muscle strength, and physical function 14 weeks after hip fracture surgery, compared to physiotherapy, protein-rich nutritional supplement plus placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >=60 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)
排除标准
- •Postoperative weight-bearing restrictions
- •Multiple fractures
- •Active cancer or suspected pathological fracture
- •Patients unable/unwilling to cooperate to 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 (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, 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 PSA assesed 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).
研究组 & 干预措施
Nandrolone Decanoate
Experimental
Physical therapy with strength training, protein-rich nutritional supplement plus Nandrolone decanoate.
干预措施: Nandrolone Decanoate (Drug)
Nandrolone Decanoate
Experimental
Physical therapy with strength training, protein-rich nutritional supplement plus Nandrolone decanoate.
干预措施: Protein-rich nutritional supplement (Dietary Supplement)
Nandrolone Decanoate
Experimental
Physical therapy with strength training, protein-rich nutritional supplement plus Nandrolone decanoate.
干预措施: Physical therapy (Other)
Placebo (Sodium Chloride)
Placebo Comparator
Physical therapy with strength training, protein-rich nutritional supplement plus placebo.
干预措施: Protein-rich nutritional supplement (Dietary Supplement)
Placebo (Sodium Chloride)
Placebo Comparator
Physical therapy with strength training, protein-rich nutritional supplement plus placebo.
干预措施: Physical therapy (Other)
Placebo (Sodium Chloride)
Placebo Comparator
Physical therapy with strength training, protein-rich nutritional supplement plus placebo.
干预措施: Sodium Chloride 9mg/ml Injection (Drug)
结局指标
主要结局
Change in maximal isometric knee-extension strength (Nm/Kg) in the fractured limb.
时间窗: Baseline and 14 weeks after inclusion
Measured using a belt fixed handheld dynamometer.
次要结局
- Maximal isometric knee-extension strength (Nm/Kg) in the fractured limb in % of the non-fractured limb(Baseline and 14 weeks after inclusion)
- Maximal isometric knee-extension strength (Nm/Kg) in the non-fractured limb.(Baseline and 14 weeks after inclusion.)
- Hand-grip strength in the dominant hand.(Baseline and 14 weeks after inclusion.)
- Gait speed will be assessed using the 10 meter walk test (10mWT)(Baseline and 14 weeks after inclusion.)
- The de Mortons Mobility Index (DEMMI)(Baseline and 14 weeks after inclusion.)
- Bone mineral density (BMD)(Baseline and 14 weeks after inclusion.)
- Lean body mass (LBM)(Baseline and 14 weeks after inclusion.)
- Fat mass(Baseline and 14 weeks after inclusion.)
- Hip fracture related pain at rest and during outcome assessment(Baseline and 3/6/9/12/14 weeks after inclusion.)
- Residential status (including home care)(Baseline (prefracture) and 14 weeks after inclusion.)
- Nutrition screening using the Mini Nutritional Assessment Short Form (MNA-SF).(Baseline (prefracture) and 14 weeks after inclusion.)
- Depression is assessed using the Geriatric Depression Scale (GDS-15)(Baseline (prefracture) and 14 weeks after inclusion.)
- Functional level is assessed by the New Mobility Score (NMS).(Baseline (prefracture) and 3/6/9/12/14 weeks after inclusion.)
- The EQ-5D-3L is used for assessing health related quality of life.(Baseline (prefracture) and 14 weeks after inclusion)
- Timed up and go test (TUG)(Baseline and 14 weeks after inclusion.)
- Upright time(Measured from the time of the control week 12 and one week ahead.)
- Global Rating of Change Scale(Baseline, and 3/6/9/12/14 weeks after inclusion.)
- The Short Falls Efficacy Scale-International (Short FES-I)(Baseline and 14 weeks after inclusion.)
- Falls(Assessed through weekly telephone interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.)
- Total testosterone (nmol/l)(Baseline and 14 weeks after inclusion.)
- Mortality(14 weeks after inclusion.)
- Fatigue is assessed using the Short Form (36) Health Survey (SF36) vitality subscale.(Baseline (prefracture), and 3/6/9/12/14 weeks after inclusion.)
- Re-admissions(14 weeks after inclusion.)
- Luteinizing hormone (LH), IU/l(Baseline and 14 weeks after inclusion.)
- Follicle-stimulating hormone (FSH) IU/l(Baseline and 14 weeks after inclusion.)
- Sex hormone binding globulin (SHBG), nmol/l(Baseline and 14 weeks after inclusion.)
- Lipid profile (Total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride) mmol/l.(Baseline and 14 weeks after inclusion.)
- C-reactive protein (CRP), mg/l.(Baseline and 14 weeks after inclusion.)
- Hematocrit (B-Erythrocyte, vol.fr.)(Baseline, and 3/6/9/12/14 weeks after inclusion.)
- Hemoglobin(Baseline, and 3/6/9/12/14 weeks after inclusion.)
- Creatinine(Baseline, and 3/6/9/12/14 weeks after inclusion.)
- Carbamide(Baseline, and 3/6/9/12/14 weeks after inclusion.)
- Sodium (Na+)(Baseline, and 3/6/9/12/14 weeks after inclusion.)
- Potassium (K+)(Baseline, and 3/6/9/12/14 weeks after inclusion.)
- Calcium(Baseline, and 3/6/9/12/14 weeks after inclusion.)
- Other adverse events(Assessed through weekly interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.)
- Edema in non-fractured leg(Assessed at baseline and through weekly interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.)
- Liver tests (Albumin, Alanine aminotransferase (ALAT), γ-glutamyltransferase, Bilirubin)(Baseline, and 3/6/9/12/14 weeks after inclusion.)
- International Normalized Ratio (INR)(Baseline, and 3/6/9/12/14 weeks after inclusion.)
- Prostate Specific Antigen (PSA)(Baseline, and 3/6/9/12/14 weeks after inclusion.)
- Glucose(Baseline, and 3/6/9/12/14 weeks after inclusion.)
- Blood pressure(Baseline, and 3/6/9/12/14 weeks after inclusion.)
- Facial hirsutism(Baseline, and 3/6/9/12/14 weeks after inclusion.)
- Hoarseness(Assessed at baseline and through weekly telephone interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.)
研究者
Morten Tange Kristensen PT, PhD
Senior Researcher
Hvidovre University Hospital
研究点 (1)
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