Skip to main content
OpenTrials
Completed

NCT Number: NCT03545347

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hip Fractures Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Nandrolone Decanoate

Drug

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

Protein-rich nutritional supplement

Dietary 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 names: Nestle Resource fiber 2.0

Physical Therapy

Other

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 names: Physiotherapy

Sodium Chloride 9mg/ml Injection

Drug

Placebo injection of 1 ml Sodium Chloride

Other names: Saline

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Morten Tange Kristensen PT, PhD

Other

Registry information

Official study 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)

Acronym: HIP-SAP

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 4, 2018
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.