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Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture. (HIP-SAP)

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ClinicalTrials.gov Identifier: NCT03545347
Recruitment Status : Recruiting
First Posted : June 4, 2018
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Morten Tange Kristensen PT, PhD, Hvidovre University Hospital

Tracking Information
First Submitted Date  ICMJE May 18, 2018
First Posted Date  ICMJE June 4, 2018
Last Update Posted Date September 9, 2019
Actual Study Start Date  ICMJE September 3, 2018
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03545347 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2018)
  • Maximal isometric knee-extension strength (Nm/Kg) in the fractured limb in % of the non-fractured limb [ Time Frame: Baseline and 14 weeks after inclusion ]
    Measured using a belt fixed handheld dynamometer.
  • Maximal isometric knee-extension strength (Nm/Kg) in the non-fractured limb. [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Measured using a belt fixed handheld dynamometer.
  • Hand-grip strength in the dominant hand. [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Measured using a handheld dynamometer, expressed in kg.
  • Bone mineral density (BMD) [ Time Frame: Baseline and 14 weeks after inclusion. ]
    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.
  • Lean body mass (LBM) [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Registration of total body, legs bilaterally, arms bilaterally. Assessed by DEXA and expressed in kg.
  • Fat mass [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Total body. Assessed by DEXA and expressed in kg.
  • Nutrition screening using the Mini Nutritional Assessment Short Form (MNA-SF). [ Time Frame: Baseline (prefracture) and 14 weeks after inclusion. ]
    Total score from 0-14 points, high scores indicating better nutritional status
  • Gait speed will be assessed using the 10 meter walk test (10mWT) [ Time Frame: Baseline and 14 weeks after inclusion. ]
    The results reported in meters walked per second (m/s).
  • Timed up and go test (TUG) [ Time Frame: Baseline and 14 weeks after inclusion. ]
    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.
  • The de Mortons Mobility Index (DEMMI) [ Time Frame: Baseline and 14 weeks after inclusion. ]
    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.
  • Upright time [ Time Frame: Measured from the time of the control week 12 and one week ahead. ]
    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.
  • Functional level is assessed by the New Mobility Score (NMS). [ Time Frame: Baseline (prefracture) and 3/6/9/12/14 weeks after inclusion. ]
    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.
  • The EQ-5D-3L is used for assessing health related quality of life. [ Time Frame: Baseline (prefracture) and 14 weeks after inclusion ]
    It is administered via interview.
  • Hip fracture related pain at rest and during outcome assessment [ Time Frame: Baseline and 3/6/9/12/14 weeks after inclusion. ]
    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.
  • Global Rating of Change Scale [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Assessment of patient perceived change in walking ability during the trial period.
  • The Short Falls Efficacy Scale-International (Short FES-I) [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Measures the patient's fear of falling (Score 7-28, higher scores indicating a higher fear of falling). It is administered as an interview.
  • Fatigue is assessed using the Short Form (36) Health Survey (SF36) vitality subscale. [ Time Frame: Baseline (prefracture), and 3/6/9/12/14 weeks after inclusion. ]
    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.
  • Depression is assessed using the Geriatric Depression Scale (GDS-15) [ Time Frame: Baseline (prefracture) and 14 weeks after inclusion. ]
    Administered as an interview. Score range 0-15.
  • Re-admissions [ Time Frame: 14 weeks after inclusion. ]
    Assessed through the medical journal/interviews.
  • Residential status (including home care) [ Time Frame: Baseline (prefracture) and 14 weeks after inclusion. ]
    Change in residential status and home care (help provided in the patients home). Assessed through the medical journal/interviews.
  • Mortality [ Time Frame: 14 weeks after inclusion. ]
    Assessed through the medical journal/Danish civil register.
  • Falls [ Time Frame: Assessed through weekly telephone interviews and hospital visits at 3/6/9/12/14 weeks after inclusion. ]
    Number of falls. Assessed through interviews
  • Total testosterone (nmol/l) [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Blood test
  • Luteinizing hormone (LH), IU/l [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Blood test
  • Follicle-stimulating hormone (FSH) IU/l [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Blood test
  • Sex hormone binding globulin (SHBG), nmol/l [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Blood test
  • Lipid profile (Total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride) mmol/l. [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Blood test
  • C-reactive protein (CRP), mg/l. [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Blood test
  • Hematocrit (B-Erythrocyte, vol.fr.) [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test
  • Hemoglobin [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test
  • Creatinine [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test
  • Carbamide [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test
  • Sodium (Na+) [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test
  • Potassium (K+) [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test
  • Calcium [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test
  • Liver tests (Albumin, Alanine aminotransferase (ALAT), γ-glutamyltransferase, Bilirubin) [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test
  • International Normalized Ratio (INR) [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test
  • Prostate Specific Antigen (PSA) [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test
  • Glucose [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test
  • Blood pressure [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, assessed using a 'Blood pressure monitor' (mmHg).
  • Facial hirsutism [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Change in facial hair assessed using the 2 face-related items of Ferriman-Galway Hirsutism Score.
  • Hoarseness [ Time Frame: Assessed at baseline and through weekly telephone interviews and hospital visits at 3/6/9/12/14 weeks after inclusion. ]
    Change in voice, reported by patient or observed by interviewer (no specific score available for this evaluation).
  • Other adverse events [ Time Frame: Assessed through weekly interviews and hospital visits at 3/6/9/12/14 weeks after inclusion. ]
    Assessed through interview, observation
  • Edema in non-fractured leg [ Time Frame: Assessed at baseline and through weekly interviews and hospital visits at 3/6/9/12/14 weeks after inclusion. ]
    Change in edema assessed through interview
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture.
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Hip Fractures
Intervention  ICMJE
  • 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.
    Other Names:
    • Deca-durabolin
    • anabolic steroid
  • 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 Name: Nestle Resource fiber 2.0
  • 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.
    Other Name: Physiotherapy
  • Drug: Sodium Chloride 9mg/ml Injection
    Placebo injection of 1 ml Sodium Chloride
    Other Name: Saline
Study Arms  ICMJE
  • Experimental: Nandrolone Decanoate
    Physical therapy with strength training, protein-rich nutritional supplement plus Nandrolone decanoate.
    Interventions:
    • Drug: Nandrolone Decanoate
    • Dietary Supplement: Protein-rich nutritional supplement
    • Other: Physical therapy
  • Placebo Comparator: Placebo (Sodium Chloride)
    Physical therapy with strength training, protein-rich nutritional supplement plus placebo.
    Interventions:
    • Dietary Supplement: Protein-rich nutritional supplement
    • Other: Physical therapy
    • Drug: Sodium Chloride 9mg/ml Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 1, 2018)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Signe Hulsbaek, PT, MPH +45 38621510 signe.hulsbaek@regionh.dk
Contact: Morten T Kristensen, PT, PhD +45 38626191 morten.tange.kristensen@regionh.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03545347
Other Study ID Numbers  ICMJE HvidovreUH-HIP-SAP-1
2017-001543-13 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Morten Tange Kristensen PT, PhD, Hvidovre University Hospital
Study Sponsor  ICMJE Morten Tange Kristensen PT, PhD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Morten T Kristensen, PT, PhD Department of Occupational and Physical Therapy and Department of Orthopedic Surgery, Amager-Hvidovre University Hospital
PRS Account Hvidovre University Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP