Nutritional Support in Femur Fracture Rehabilitation

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

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.

Study Overview

• Status: Terminated
• Conditions: Femur Fracture
• Intervention / Treatment: Dietary supplement: Fortifit®

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Asst Gaetano Pini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

  1. More than 10 µg (400 IU) of daily Vitamin D intake from medical sources
  2. More than 500 mg of daily calcium intake from medical sources.
  3. Adherence to a high-energy or high-protein diet (up to three months before starting the study)
  4. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fortifit®; 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®; 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.
No Intervention: Control group; Best local diet

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Barichella Michela
• Investigators: Principal Investigator: Lorenzo Panella, MD, ASST Gaetano Pini-CTO

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2020
• Primary Completion (Actual): December 20, 2020
• Study Completion (Actual): December 20, 2020

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures
• Other Study ID Numbers: parere 72_2020bis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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