Nutritional Support in Femur Fracture Rehabilitation

Not Applicable

Terminated

• Conditions: Femur Fracture

• Registration Number: NCT04306536
• Lead Sponsor: Barichella Michela

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.

Study Timeline

• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-13
• Study Start: 2020-06-19
• Primary Completion: 2020-12-20
• Study Completion: 2020-12-20
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-27
• Last Update Posted: 2025-09-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physical performance - gait speed	4 weeks	Gait speed at the 10-meter walking test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asst Gaetano Pini; 🇮🇹 Milan, Italy