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

Hip Fractures Clinical Trial

— HIP-SAP  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545347
• Other study ID #: HvidovreUH-HIP-SAP-1
• Secondary ID: 2017-001543-13
• Status: Completed
• Phase: Phase 2
• Start date: September 3, 2018
• Est. completion date: June 3, 2020

Study information

• Verified date: February 2021
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 3, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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, ?-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).

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Drug:
• Nandrolone Decanoate
Injections every 3 weeks, last injection at week 12. Women 50 mg, men with total testosterone = 11 nmol/l will receive 100 mg, and men with total testosterone < 11 nmol/l will receive a dose of 200 mg.

Dietary Supplement:
• Protein-rich nutritional 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.

Other:
• Physical therapy
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.

Drug:
• Sodium Chloride 9mg/ml Injection
Placebo injection of 1 ml Sodium Chloride

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Morten Tange Kristensen PT, PhD

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maximal isometric knee-extension strength (Nm/Kg) in the fractured limb.	Measured using a belt fixed handheld dynamometer.	Baseline and 14 weeks after inclusion
Secondary	Maximal isometric knee-extension strength (Nm/Kg) in the fractured limb in % of the non-fractured limb	Measured using a belt fixed handheld dynamometer.	Baseline and 14 weeks after inclusion
Secondary	Maximal isometric knee-extension strength (Nm/Kg) in the non-fractured limb.	Measured using a belt fixed handheld dynamometer.	Baseline and 14 weeks after inclusion.
Secondary	Hand-grip strength in the dominant hand.	Measured using a handheld dynamometer, expressed in kg.	Baseline and 14 weeks after inclusion.
Secondary	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.	Baseline and 14 weeks after inclusion.
Secondary	Lean body mass (LBM)	Registration of total body, legs bilaterally, arms bilaterally. Assessed by DEXA and expressed in kg.	Baseline and 14 weeks after inclusion.
Secondary	Fat mass	Total body. Assessed by DEXA and expressed in kg.	Baseline and 14 weeks after inclusion.
Secondary	Nutrition screening using the Mini Nutritional Assessment Short Form (MNA-SF).	Total score from 0-14 points, high scores indicating better nutritional status	Baseline (prefracture) and 14 weeks after inclusion.
Secondary	Gait speed will be assessed using the 10 meter walk test (10mWT)	The results reported in meters walked per second (m/s).	Baseline and 14 weeks after inclusion.
Secondary	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.	Baseline and 14 weeks after inclusion.
Secondary	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.	Baseline and 14 weeks after inclusion.
Secondary	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.	Measured from the time of the control week 12 and one week ahead.
Secondary	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.	Baseline (prefracture) and 3/6/9/12/14 weeks after inclusion.
Secondary	The EQ-5D-3L is used for assessing health related quality of life.	It is administered via interview.	Baseline (prefracture) and 14 weeks after inclusion
Secondary	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.	Baseline and 3/6/9/12/14 weeks after inclusion.
Secondary	Global Rating of Change Scale	Assessment of patient perceived change in walking ability during the trial period.	Baseline, and 3/6/9/12/14 weeks after inclusion.
Secondary	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.	Baseline and 14 weeks after inclusion.
Secondary	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.	Baseline (prefracture), and 3/6/9/12/14 weeks after inclusion.
Secondary	Depression is assessed using the Geriatric Depression Scale (GDS-15)	Administered as an interview. Score range 0-15.	Baseline (prefracture) and 14 weeks after inclusion.
Secondary	Re-admissions	Assessed through the medical journal/interviews.	14 weeks after inclusion.
Secondary	Residential status (including home care)	Change in residential status and home care (help provided in the patients home). Assessed through the medical journal/interviews.	Baseline (prefracture) and 14 weeks after inclusion.
Secondary	Mortality	Assessed through the medical journal/Danish civil register.	14 weeks after inclusion.
Secondary	Falls	Number of falls. Assessed through interviews	Assessed through weekly telephone interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.
Secondary	Total testosterone (nmol/l)	Blood test	Baseline and 14 weeks after inclusion.
Secondary	Luteinizing hormone (LH), IU/l	Blood test	Baseline and 14 weeks after inclusion.
Secondary	Follicle-stimulating hormone (FSH) IU/l	Blood test	Baseline and 14 weeks after inclusion.
Secondary	Sex hormone binding globulin (SHBG), nmol/l	Blood test	Baseline and 14 weeks after inclusion.
Secondary	Lipid profile (Total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride) mmol/l.	Blood test	Baseline and 14 weeks after inclusion.
Secondary	C-reactive protein (CRP), mg/l.	Blood test	Baseline and 14 weeks after inclusion.
Secondary	Hematocrit (B-Erythrocyte, vol.fr.)	Safety parameter, blood test	Baseline, and 3/6/9/12/14 weeks after inclusion.
Secondary	Hemoglobin	Safety parameter, blood test	Baseline, and 3/6/9/12/14 weeks after inclusion.
Secondary	Creatinine	Safety parameter, blood test	Baseline, and 3/6/9/12/14 weeks after inclusion.
Secondary	Carbamide	Safety parameter, blood test	Baseline, and 3/6/9/12/14 weeks after inclusion.
Secondary	Sodium (Na+)	Safety parameter, blood test	Baseline, and 3/6/9/12/14 weeks after inclusion.
Secondary	Potassium (K+)	Safety parameter, blood test	Baseline, and 3/6/9/12/14 weeks after inclusion.
Secondary	Calcium	Safety parameter, blood test	Baseline, and 3/6/9/12/14 weeks after inclusion.
Secondary	Liver tests (Albumin, Alanine aminotransferase (ALAT), ?-glutamyltransferase, Bilirubin)	Safety parameter, blood test	Baseline, and 3/6/9/12/14 weeks after inclusion.
Secondary	International Normalized Ratio (INR)	Safety parameter, blood test	Baseline, and 3/6/9/12/14 weeks after inclusion.
Secondary	Prostate Specific Antigen (PSA)	Safety parameter, blood test	Baseline, and 3/6/9/12/14 weeks after inclusion.
Secondary	Glucose	Safety parameter, blood test	Baseline, and 3/6/9/12/14 weeks after inclusion.
Secondary	Blood pressure	Safety parameter, assessed using a 'Blood pressure monitor' (mmHg).	Baseline, and 3/6/9/12/14 weeks after inclusion.
Secondary	Facial hirsutism	Change in facial hair assessed using the 2 face-related items of Ferriman-Galway Hirsutism Score.	Baseline, and 3/6/9/12/14 weeks after inclusion.
Secondary	Hoarseness	Change in voice, reported by patient or observed by interviewer (no specific score available for this evaluation).	Assessed at baseline and through weekly telephone interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.
Secondary	Other adverse events	Assessed through interview, observation	Assessed through weekly interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.
Secondary	Edema in non-fractured leg	Change in edema assessed through interview	Assessed at baseline and through weekly interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.