Clinical trial NCT03545347: Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture.
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hip Fractures
Keywords: Rehabilitation
Physiotherapy
Strength training
Anabolic steroids
Nutritional supplement
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 29
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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)
* 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).

Primary outcomes:
measure: Change in maximal isometric knee-extension strength (Nm/Kg) in the fractured limb.
timeFrame: Baseline and 14 weeks after inclusion
Secondary outcomes:
measure: Maximal isometric knee-extension strength (Nm/Kg) in the fractured limb in % of the non-fractured limb
timeFrame: Baseline and 14 weeks after inclusion
measure: Maximal isometric knee-extension strength (Nm/Kg) in the non-fractured limb.
timeFrame: Baseline and 14 weeks after inclusion.
measure: Hand-grip strength in the dominant hand.
timeFrame: Baseline and 14 weeks after inclusion.
measure: Bone mineral density (BMD)
timeFrame: Baseline and 14 weeks after inclusion.
measure: Lean body mass (LBM)
timeFrame: Baseline and 14 weeks after inclusion.
measure: Fat mass
timeFrame: Baseline and 14 weeks after inclusion.
measure: Nutrition screening using the Mini Nutritional Assessment Short Form (MNA-SF).
timeFrame: Baseline (prefracture) and 14 weeks after inclusion.
measure: Gait speed will be assessed using the 10 meter walk test (10mWT)
timeFrame: Baseline and 14 weeks after inclusion.
measure: Timed up and go test (TUG)
timeFrame: Baseline and 14 weeks after inclusion.
measure: The de Mortons Mobility Index (DEMMI)
timeFrame: Baseline and 14 weeks after inclusion.
measure: Upright time
timeFrame: Measured from the time of the control week 12 and one week ahead.
measure: Functional level is assessed by the New Mobility Score (NMS).
timeFrame: Baseline (prefracture) and 3/6/9/12/14 weeks after inclusion.
measure: The EQ-5D-3L is used for assessing health related quality of life.
timeFrame: Baseline (prefracture) and 14 weeks after inclusion
measure: Hip fracture related pain at rest and during outcome assessment
timeFrame: Baseline and 3/6/9/12/14 weeks after inclusion.
measure: Global Rating of Change Scale
timeFrame: Baseline, and 3/6/9/12/14 weeks after inclusion.
measure: The Short Falls Efficacy Scale-International (Short FES-I)
timeFrame: Baseline and 14 weeks after inclusion.
measure: Fatigue is assessed using the Short Form (36) Health Survey (SF36) vitality subscale.
timeFrame: Baseline (prefracture), and 3/6/9/12/14 weeks after inclusion.
measure: Depression is assessed using the Geriatric Depression Scale (GDS-15)
timeFrame: Baseline (prefracture) and 14 weeks after inclusion.
measure: Re-admissions
timeFrame: 14 weeks after inclusion.
measure: Residential status (including home care)
timeFrame: Baseline (prefracture) and 14 weeks after inclusion.
measure: Mortality
timeFrame: 14 weeks after inclusion.
measure: Falls
timeFrame: Assessed through weekly telephone interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.
measure: Total testosterone (nmol/l)
timeFrame: Baseline and 14 weeks after inclusion.
measure: Luteinizing hormone (LH), IU/l
timeFrame: Baseline and 14 weeks after inclusion.
measure: Follicle-stimulating hormone (FSH) IU/l
timeFrame: Baseline and 14 weeks after inclusion.
measure: Sex hormone binding globulin (SHBG), nmol/l
timeFrame: Baseline and 14 weeks after inclusion.
measure: Lipid profile (Total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride) mmol/l.
timeFrame: Baseline and 14 weeks after inclusion.
measure: C-reactive protein (CRP), mg/l.
timeFrame: Baseline and 14 weeks after inclusion.
measure: Hematocrit (B-Erythrocyte, vol.fr.)
timeFrame: Baseline, and 3/6/9/12/14 weeks after inclusion.
measure: Hemoglobin
timeFrame: Baseline, and 3/6/9/12/14 weeks after inclusion.
measure: Creatinine
timeFrame: Baseline, and 3/6/9/12/14 weeks after inclusion.
measure: Carbamide
timeFrame: Baseline, and 3/6/9/12/14 weeks after inclusion.
measure: Sodium (Na+)
timeFrame: Baseline, and 3/6/9/12/14 weeks after inclusion.
measure: Potassium (K+)
timeFrame: Baseline, and 3/6/9/12/14 weeks after inclusion.
measure: Calcium
timeFrame: Baseline, and 3/6/9/12/14 weeks after inclusion.
measure: Liver tests (Albumin, Alanine aminotransferase (ALAT), γ-glutamyltransferase, Bilirubin)
timeFrame: Baseline, and 3/6/9/12/14 weeks after inclusion.
measure: International Normalized Ratio (INR)
timeFrame: Baseline, and 3/6/9/12/14 weeks after inclusion.
measure: Prostate Specific Antigen (PSA)
timeFrame: Baseline, and 3/6/9/12/14 weeks after inclusion.
measure: Glucose
timeFrame: Baseline, and 3/6/9/12/14 weeks after inclusion.
measure: Blood pressure
timeFrame: Baseline, and 3/6/9/12/14 weeks after inclusion.
measure: Facial hirsutism
timeFrame: Baseline, and 3/6/9/12/14 weeks after inclusion.
measure: Hoarseness
timeFrame: Assessed at baseline and through weekly telephone interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.
measure: Other adverse events
timeFrame: Assessed through weekly interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.
measure: Edema in non-fractured leg
timeFrame: Assessed at baseline and through weekly interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
affiliation: Department of Occupational and Physical Therapy and Department of Orthopedic Surgery, Amager-Hvidovre University Hospital
name: Morten T Kristensen, PT, PhD
role: STUDY_DIRECTOR
References:
citation: Hulsbaek S, Bandholm T, Ban I, Foss NB, Jensen JB, Kehlet H, Kristensen MT. Feasibility and preliminary effect of anabolic steroids in addition to strength training and nutritional supplement in rehabilitation of patients with hip fracture: a randomized controlled pilot trial (HIP-SAP1 trial). BMC Geriatr. 2021 May 20;21(1):323. doi: 10.1186/s12877-021-02273-z.
citation: Hulsbaek S, Ban I, Aasvang TK, Jensen JB, Kehlet H, Foss NB, Bandholm T, Kristensen MT. 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). Trials. 2019 Dec 23;20(1):763. doi: 10.1186/s13063-019-3845-y.