Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture.

Morten Tange Kristensen PT, PhD29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Hip Fractures

Interventions

Protein-rich nutritional supplementDIETARY_SUPPLEMENT

The protein-rich nutritional supplement is a liquid containing 18 g milk-based protein pr bottle. Patients will receive a minimum of 1.35 g/kg bodyweight/day); which means that most patients will receive 2 bottles per day for 12 weeks.

Physical therapyOTHER

The physical therapy intervention will include progressive strength training initiated daily on weekdays during hospitalization and continued twice per week in the outpatient rehabilitation program in the municipality (treatment as usual but with strength training as an obligatory component) for a total intervention period of 12 weeks from time of inclusion.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Change in maximal isometric knee-extension strength (Nm/Kg) in the fractured limb.

Measured using a belt fixed handheld dynamometer.

Time frame: Baseline and 14 weeks after inclusion

Secondary Outcomes

Maximal isometric knee-extension strength (Nm/Kg) in the fractured limb in % of the non-fractured limb

Measured using a belt fixed handheld dynamometer.

Time frame: Baseline and 14 weeks after inclusion

Maximal isometric knee-extension strength (Nm/Kg) in the non-fractured limb.

Measured using a belt fixed handheld dynamometer.

Time frame: Baseline and 14 weeks after inclusion.

Hand-grip strength in the dominant hand.

Measured using a handheld dynamometer, expressed in kg.

Time frame: Baseline and 14 weeks after inclusion.

Bone mineral density (BMD)

Registration of total body, total hip, femoral neck, lumbar spine. Assessed by Dual-energy X-ray absorptiometry (DEXA), expressed in g/cm2. Further the T-score is registered. The DEXA is conducted in accordance with the department's standard procedures.

Time frame: Baseline and 14 weeks after inclusion.

Lean body mass (LBM)

Registration of total body, legs bilaterally, arms bilaterally. Assessed by DEXA and expressed in kg.

Time frame: Baseline and 14 weeks after inclusion.

Fat mass

Total body. Assessed by DEXA and expressed in kg.

Time frame: Baseline and 14 weeks after inclusion.

Nutrition screening using the Mini Nutritional Assessment Short Form (MNA-SF).

Total score from 0-14 points, high scores indicating better nutritional status

Time frame: Baseline (prefracture) and 14 weeks after inclusion.

Gait speed will be assessed using the 10 meter walk test (10mWT)

The results reported in meters walked per second (m/s).

Time frame: Baseline and 14 weeks after inclusion.

Timed up and go test (TUG)

Performed using a 4 wheeled rollator and measured in seconds. The patient has to rise from a chair, walk 3 meters, turnaround, walk back and sit down.

Time frame: Baseline and 14 weeks after inclusion.

The de Mortons Mobility Index (DEMMI)

Measures mobility and consists of 15 mobility items ranging from mobility in bed to dynamic balance. The test results in a total score from 0 to 100 with 100 representing the highest level of mobility.

Time frame: Baseline and 14 weeks after inclusion.

Upright time

Assessed by using a body-worn accelerometer-based activity monitor (ActivePAL). The monitor will be attached to the thigh. The patient will wear the monitor for 7 days.

Time frame: Measured from the time of the control week 12 and one week ahead.

Functional level is assessed by the New Mobility Score (NMS).

The patients are interviewed about walking ability indoor, outdoor and when shopping. the week prior to hospital admission. The total score range from 0 to 9. A Higher score indicating higher independence.

Time frame: Baseline (prefracture) and 3/6/9/12/14 weeks after inclusion.

The EQ-5D-3L is used for assessing health related quality of life.

It is administered via interview.

Time frame: Baseline (prefracture) and 14 weeks after inclusion

Hip fracture related pain at rest and during outcome assessment

It is evaluated by Verbal Ranking Scale (VRS). The patient expresses pain levels on a verbal scale from 0-4, higher score indicating higher pain levels.

Time frame: Baseline and 3/6/9/12/14 weeks after inclusion.

Global Rating of Change Scale

Assessment of patient perceived change in walking ability during the trial period.

Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.

The Short Falls Efficacy Scale-International (Short FES-I)

Measures the patient's fear of falling (Score 7-28, higher scores indicating a higher fear of falling). It is administered as an interview.

Time frame: Baseline and 14 weeks after inclusion.

Fatigue is assessed using the Short Form (36) Health Survey (SF36) vitality subscale.

The scale consists of 4 items related to fatigue/energy. Score range from 0-100 points; high score defines a more favorable health state. Administered as an interview.

Time frame: Baseline (prefracture), and 3/6/9/12/14 weeks after inclusion.

Depression is assessed using the Geriatric Depression Scale (GDS-15)

Administered as an interview. Score range 0-15.

Time frame: Baseline (prefracture) and 14 weeks after inclusion.

Re-admissions

Assessed through the medical journal/interviews.

Time frame: 14 weeks after inclusion.

Residential status (including home care)

Change in residential status and home care (help provided in the patients home). Assessed through the medical journal/interviews.

Time frame: Baseline (prefracture) and 14 weeks after inclusion.

Mortality

Assessed through the medical journal/Danish civil register.

Time frame: 14 weeks after inclusion.

Falls

Number of falls. Assessed through interviews

Time frame: Assessed through weekly telephone interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.

Total testosterone (nmol/l)

Blood test

Time frame: Baseline and 14 weeks after inclusion.

Luteinizing hormone (LH), IU/l

Blood test

Time frame: Baseline and 14 weeks after inclusion.

Follicle-stimulating hormone (FSH) IU/l

Blood test

Time frame: Baseline and 14 weeks after inclusion.

Sex hormone binding globulin (SHBG), nmol/l

Blood test

Time frame: Baseline and 14 weeks after inclusion.

Lipid profile (Total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride) mmol/l.

Blood test

Time frame: Baseline and 14 weeks after inclusion.

C-reactive protein (CRP), mg/l.

Blood test

Time frame: Baseline and 14 weeks after inclusion.

Hematocrit (B-Erythrocyte, vol.fr.)

Safety parameter, blood test

Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.

Hemoglobin

Safety parameter, blood test

Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.

Creatinine

Safety parameter, blood test

Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.

Carbamide

Safety parameter, blood test

Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.

Sodium (Na+)

Safety parameter, blood test

Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.

Potassium (K+)

Safety parameter, blood test

Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.

Calcium

Safety parameter, blood test

Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.

Liver tests (Albumin, Alanine aminotransferase (ALAT), γ-glutamyltransferase, Bilirubin)

Safety parameter, blood test

Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.

International Normalized Ratio (INR)

Safety parameter, blood test

Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.

Prostate Specific Antigen (PSA)

Safety parameter, blood test

Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.

Glucose

Safety parameter, blood test

Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.

Blood pressure

Safety parameter, assessed using a 'Blood pressure monitor' (mmHg).

Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.

Facial hirsutism

Change in facial hair assessed using the 2 face-related items of Ferriman-Galway Hirsutism Score.

Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.

Hoarseness

Change in voice, reported by patient or observed by interviewer (no specific score available for this evaluation).

Time frame: Assessed at baseline and through weekly telephone interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.

Other adverse events

Assessed through interview, observation

Time frame: Assessed through weekly interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.

Edema in non-fractured leg

Change in edema assessed through interview

Time frame: Assessed at baseline and through weekly interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.

Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes