Nutritional Support in Femur Fracture Rehabilitation

Femur Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04306536
• Other study ID #: parere 72_2020bis
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2020
• Est. completion date: December 20, 2020

Study information

• Verified date: July 2020
• Source: ASST Gaetano Pini-CTO
• Contact: Michela Barichella, MD
• Phone: 02947743222
• Email: Michela.Barichella[@]asst-pini-cto.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 20, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone

Intervention

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.

Locations

Country	Name	City	State
Italy	Asst Gaetano Pini	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Barichella Michela

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical performance - gait speed	Gait speed at the 10-meter walking test	4 weeks
Secondary	Physical performance - Timed Up and Go test	Change in timed up and go test	4 weeks
Secondary	Functional status - Barthel	Change in Barthel index score	4 weeks
Secondary	Functional status - handgrip strength	Change in handgrip strength	4 weeks
Secondary	Body composition - phase angle	Change in phase angle	4 weeks
Secondary	Body composition - muscle mass	Change in muscle mass	4 weeks
Secondary	Body composition - fat-free mass	Change in fat-free mass	4 weeks
Secondary	Body composition - fat-free mass index	Change in fat-free mass index	4 weeks
Secondary	Body weight	Change in body weight	4 weeks
Secondary	Calf circumference	Change in calf circumference	4 weeks
Secondary	Modality of discharge	Difference in the proportion of patients discharged at home	4 weeks