Nutritional Support in Femur Fracture Rehabilitation

Study Overview
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Brief Summary
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This randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation program in old adults with femur fracture treated with surgery.

Detailed Description
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Muscle-target nutritional supplementation has been domonstrated to enhance the recovery of muscle mass and increase the efficacy of a rehabilitation program in patients suffering from sarcopenia. Femure fracture is responsible for increased immobilization resulting in loss of muscle mass which may be further emphasized by surgical stress. This randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation program in old adults with femur fracture treated with surgery.

Official Title
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Muscle-targeted Nutritional Support in Post-surgical Rehabilitation for Femur Fracture

Conditions
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Femur Fracture

Intervention / Treatment
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* Dietary Supplement: Fortifit®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 60 years or older admission for physical rehabilitation after surgery for femur fracture informed consent Exclusion Criteria: Any malignant disease during the last five years Known kidney failure (previous glomerular filtration rate <30 ml/min); Known liver failure (Child B or C) Psychiatric disease Severe cognitive impairment (Mini Mental State Examination <18) Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis) Indications related to the study product: More than 10 µg (400 IU) of daily Vitamin D intake from medical sources More than 500 mg of daily calcium intake from medical sources. Adherence to a high-energy or high-protein diet (up to three months before starting the study) Hypersensitivity to any component of the investigational nutritional supplement (including cow milk protein allergy to milk and lactose intolerance) Indication to or ongoing artificial nutrition support Inclusion in other nutrition intervention trials Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements Refusal

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fortifit®<br>Best local diet + two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers. | Dietary Supplement: Fortifit®<br>* Best local diet + two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers.<br>|
| No Intervention: Control group<br>Best local diet | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical performance - gait speed | Gait speed at the 10-meter walking test | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical performance - Timed Up and Go test | Change in timed up and go test | 4 weeks | 
| Functional status - Barthel | Change in Barthel index score | 4 weeks | 
| Functional status - handgrip strength | Change in handgrip strength | 4 weeks | 
| Body composition - phase angle | Change in phase angle | 4 weeks | 
| Body composition - muscle mass | Change in muscle mass | 4 weeks | 
| Body composition - fat-free mass | Change in fat-free mass | 4 weeks | 
| Body composition - fat-free mass index | Change in fat-free mass index | 4 weeks | 
| Body weight | Change in body weight | 4 weeks | 
| Calf circumference | Change in calf circumference | 4 weeks | 
| Modality of discharge | Difference in the proportion of patients discharged at home | 4 weeks |