Muscle-targeted Nutritional Support in Post-surgical Rehabilitation for Femur Fracture
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Femur Fracture
- Sponsor
- Barichella Michela
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Physical performance - gait speed
- Status
- Terminated
- Last Updated
- 8 months ago
Overview
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.
Investigators
Barichella Michela
Study coordinator
ASST Gaetano Pini-CTO
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)
Outcomes
Primary Outcomes
Physical performance - gait speed
Time Frame: 4 weeks
Gait speed at the 10-meter walking test
Secondary Outcomes
- Body weight(4 weeks)
- Body composition - fat-free mass(4 weeks)
- Body composition - phase angle(4 weeks)
- Body composition - muscle mass(4 weeks)
- Body composition - fat-free mass index(4 weeks)
- Physical performance - Timed Up and Go test(4 weeks)
- Functional status - Barthel(4 weeks)
- Functional status - handgrip strength(4 weeks)
- Calf circumference(4 weeks)
- Modality of discharge(4 weeks)