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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-03

Study Completion Date

2020-06-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nandrolone Decanoate

Physical therapy with strength training, protein-rich nutritional supplement plus Nandrolone decanoate.

Group Type EXPERIMENTAL

Nandrolone Decanoate

Intervention Type 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.

Protein-rich nutritional supplement

Intervention Type 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.

Physical therapy

Intervention Type 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.

Placebo (Sodium Chloride)

Physical therapy with strength training, protein-rich nutritional supplement plus placebo.

Group Type PLACEBO_COMPARATOR

Protein-rich nutritional supplement

Intervention Type 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.

Physical therapy

Intervention Type 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.

Sodium Chloride 9mg/ml Injection

Intervention Type DRUG

Placebo injection of 1 ml Sodium Chloride

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Sodium Chloride 9mg/ml Injection

Placebo injection of 1 ml Sodium Chloride

Intervention Type DRUG

Other Intervention Names

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Deca-durabolin anabolic steroid Nestle Resource fiber 2.0 Physiotherapy Saline

Eligibility Criteria

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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).

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No