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)
Overview
- Phase
- Phase 2
- Intervention
- Nandrolone Decanoate
- Conditions
- Hip Fractures
- Sponsor
- Morten Tange Kristensen PT, PhD
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Change in maximal isometric knee-extension strength (Nm/Kg) in the fractured limb.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Morten Tange Kristensen PT, PhD
Senior Researcher
Hvidovre University Hospital
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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)
Arms & Interventions
Nandrolone Decanoate
Physical therapy with strength training, protein-rich nutritional supplement plus Nandrolone decanoate.
Intervention: Nandrolone Decanoate
Nandrolone Decanoate
Physical therapy with strength training, protein-rich nutritional supplement plus Nandrolone decanoate.
Intervention: Protein-rich nutritional supplement
Nandrolone Decanoate
Physical therapy with strength training, protein-rich nutritional supplement plus Nandrolone decanoate.
Intervention: Physical therapy
Placebo (Sodium Chloride)
Physical therapy with strength training, protein-rich nutritional supplement plus placebo.
Intervention: Protein-rich nutritional supplement
Placebo (Sodium Chloride)
Physical therapy with strength training, protein-rich nutritional supplement plus placebo.
Intervention: Physical therapy
Placebo (Sodium Chloride)
Physical therapy with strength training, protein-rich nutritional supplement plus placebo.
Intervention: Sodium Chloride 9mg/ml Injection
Outcomes
Primary Outcomes
Change in maximal isometric knee-extension strength (Nm/Kg) in the fractured limb.
Time Frame: Baseline and 14 weeks after inclusion
Measured using a belt fixed handheld dynamometer.
Secondary Outcomes
- 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.)