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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 : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Morten Tange Kristensen PT, PhD, Hvidovre University Hospital

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.

Condition or disease Intervention/treatment Phase
Hip Fractures Drug: Nandrolone Decanoate Dietary Supplement: Protein-rich nutritional supplement Other: Physical therapy Drug: Sodium Chloride 9mg/ml Injection Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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)
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nandrolone Decanoate
Physical therapy with strength training, protein-rich nutritional supplement plus Nandrolone decanoate.
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

Placebo Comparator: Placebo (Sodium Chloride)
Physical therapy with strength training, protein-rich nutritional supplement plus placebo.
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. Hand-grip strength in the dominant hand. [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Measured using a handheld dynamometer, expressed in kg.

  4. 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.

  5. 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.

  6. Fat mass [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Total body. Assessed by DEXA and expressed in kg.

  7. 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

  8. 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).

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. Re-admissions [ Time Frame: 14 weeks after inclusion. ]
    Assessed through the medical journal/interviews.

  20. 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.

  21. Mortality [ Time Frame: 14 weeks after inclusion. ]
    Assessed through the medical journal/Danish civil register.

  22. 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

  23. Total testosterone (nmol/l) [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Blood test

  24. Luteinizing hormone (LH), IU/l [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Blood test

  25. Follicle-stimulating hormone (FSH) IU/l [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Blood test

  26. Sex hormone binding globulin (SHBG), nmol/l [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Blood test

  27. Lipid profile (Total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride) mmol/l. [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Blood test

  28. C-reactive protein (CRP), mg/l. [ Time Frame: Baseline and 14 weeks after inclusion. ]
    Blood test

  29. Hematocrit (B-Erythrocyte, vol.fr.) [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test

  30. Hemoglobin [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test

  31. Creatinine [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test

  32. Carbamide [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test

  33. Sodium (Na+) [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test

  34. Potassium (K+) [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test

  35. Calcium [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test

  36. 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

  37. International Normalized Ratio (INR) [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test

  38. Prostate Specific Antigen (PSA) [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test

  39. Glucose [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, blood test

  40. Blood pressure [ Time Frame: Baseline, and 3/6/9/12/14 weeks after inclusion. ]
    Safety parameter, assessed using a 'Blood pressure monitor' (mmHg).

  41. 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.

  42. 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).

  43. 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

  44. 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



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545347


Contacts
Contact: Signe Hulsbaek, PT, MPH +45 38621510 signe.hulsbaek@regionh.dk
Contact: Morten T Kristensen, PT, PhD +45 38626191 morten.tange.kristensen@regionh.dk

Locations
Denmark
Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Morten Tange Kristensen    38626191    morten.tange.kristensen@regionh.dk   
Sponsors and Collaborators
Morten Tange Kristensen PT, PhD
Investigators
Study Director: Morten T Kristensen, PT, PhD Department of Occupational and Physical Therapy and Department of Orthopedic Surgery, Amager-Hvidovre University Hospital

Responsible Party: Morten Tange Kristensen PT, PhD, Senior Researcher, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03545347     History of Changes
Other Study ID Numbers: HvidovreUH-HIP-SAP-1
2017-001543-13 ( EudraCT Number )
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Morten Tange Kristensen PT, PhD, Hvidovre University Hospital:
Rehabilitation
Physiotherapy
Strength training
Anabolic steroids
Nutritional supplement

Additional relevant MeSH terms:
Hip Fractures
Fractures, Bone
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Testosterone Congeners
Nandrolone
Nandrolone decanoate
Nandrolone phenpropionate
Decanoic acid
Anabolic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Androgens