Clinical trial NCT04306536: Nutritional Support in Femur Fracture Rehabilitation
Official title: Muscle-targeted Nutritional Support in Post-surgical Rehabilitation for Femur Fracture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Femur Fracture
Lead sponsor: ASST Gaetano Pini-CTO
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 140
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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

Primary outcomes:
measure: Physical performance - gait speed
timeFrame: 4 weeks
Secondary outcomes:
measure: Physical performance - Timed Up and Go test
timeFrame: 4 weeks
measure: Functional status - Barthel
timeFrame: 4 weeks
measure: Functional status - handgrip strength
timeFrame: 4 weeks
measure: Body composition - phase angle
timeFrame: 4 weeks
measure: Body composition - muscle mass
timeFrame: 4 weeks
measure: Body composition - fat-free mass
timeFrame: 4 weeks
measure: Body composition - fat-free mass index
timeFrame: 4 weeks
measure: Body weight
timeFrame: 4 weeks
measure: Calf circumference
timeFrame: 4 weeks
measure: Modality of discharge
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Asst Gaetano Pini
Study officials:
affiliation: ASST Gaetano Pini-CTO
name: Lorenzo Panella, MD
role: PRINCIPAL_INVESTIGATOR
References: