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Nutritional Support in Femur Fracture Rehabilitation

Primary Purpose

Femur Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Fortifit®
Sponsored by
Barichella Michela
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femur Fracture

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asst Gaetano PiniRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fortifit®

Control group

Arm Description

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.

Best local diet

Outcomes

Primary Outcome Measures

Physical performance - gait speed
Gait speed at the 10-meter walking test

Secondary Outcome Measures

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

Full Information

First Posted
March 10, 2020
Last Updated
July 22, 2020
Sponsor
Barichella Michela
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1. Study Identification

Unique Protocol Identification Number
NCT04306536
Brief Title
Nutritional Support in Femur Fracture Rehabilitation
Official Title
Muscle-targeted Nutritional Support in Post-surgical Rehabilitation for Femur Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 19, 2020 (Actual)
Primary Completion Date
December 20, 2020 (Anticipated)
Study Completion Date
December 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Barichella Michela

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femur Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fortifit®
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Best local diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Fortifit®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical performance - gait speed
Description
Gait speed at the 10-meter walking test
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Physical performance - Timed Up and Go test
Description
Change in timed up and go test
Time Frame
4 weeks
Title
Functional status - Barthel
Description
Change in Barthel index score
Time Frame
4 weeks
Title
Functional status - handgrip strength
Description
Change in handgrip strength
Time Frame
4 weeks
Title
Body composition - phase angle
Description
Change in phase angle
Time Frame
4 weeks
Title
Body composition - muscle mass
Description
Change in muscle mass
Time Frame
4 weeks
Title
Body composition - fat-free mass
Description
Change in fat-free mass
Time Frame
4 weeks
Title
Body composition - fat-free mass index
Description
Change in fat-free mass index
Time Frame
4 weeks
Title
Body weight
Description
Change in body weight
Time Frame
4 weeks
Title
Calf circumference
Description
Change in calf circumference
Time Frame
4 weeks
Title
Modality of discharge
Description
Difference in the proportion of patients discharged at home
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michela Barichella, MD
Phone
02947743222
Ext
0039
Email
Michela.Barichella@asst-pini-cto.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenzo Panella, MD
Organizational Affiliation
ASST Gaetano Pini-CTO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asst Gaetano Pini
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michela Barichella

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Nutritional Support in Femur Fracture Rehabilitation

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