The primary objective is to study the course of muscle (fiber) atrophy in elderly males and females with a fall-related hip fracture or elective hip surgery and the influence of additional nutritional support during hospital admission. Secondary…
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameters in this study are the cross-sectional area of the
quadriceps muscle and the cross-sectional area of type I and type II skeletal
muscle fibers.
Secondary outcome
Secondary outcome parameters in this study are satellite cell content in the
type I en type II skeletal muscle fibers, functional outcome 6 months after
hospital admission (determined by the use of the PASE score and Hip Fracture
Functional Recovery Scale), and quality of life (SF-36) 6 months after
admission.
Baseline subject characteristics will be obtained, including height,
bodyweight, medical history, use of medication, mental status (determined by
the MMSE), smoking, use of alcohol, use of drugs, level of habitual physical
activity (determined by PASE, Hip Fracture Recovery Scale), and quality of life
(SF-36). The nutritional status of the patients will also be measured, using
the MNA and MUST questionnaires. Lean body mass and bone mineral density will
be determined by DEXA. In addition, blood samples will be analyzed for HbA1c,
CRP, calcidiol, and TNF-α.
Background summary
Aging is associated with gradual loss of skeletal muscle mass and function,
termed sarcopenia. Loss of muscle mass may result in impaired mobility and an
increased risk of falling, thereby leading to fractures of the hip. Hip
fracture is a common cause of morbidity and mortality in the elderly.
Hospitalization and immobilization increase the rate of muscle loss. In order
to maintain muscle mass, nutritional interventions have proven to be an
effective manner to reduce the loss of muscle mass by stimulating muscle
protein synthesis. However, it is unclear to what extend loss of muscle mass
occurs during hospitalization. In addition, the role of nutritional support
with high protein drinks after surgery will be performed to overcome the loss
of muscle mass.
Study objective
The primary objective is to study the course of muscle (fiber) atrophy in
elderly males and females with a fall-related hip fracture or elective hip
surgery and the influence of additional nutritional support during hospital
admission.
Secondary objectives of this study are to study the relation between muscle
atrophy and functional outcome in elderly male and female patients with a
fall-related hip fracture; to study the relation between muscle atrophy and the
development of complications in elderly male and female patients with a
fall-related hip fracture; and to compare muscle mass and fiber
characteristics, and the changes in these parameters during hospitalization,
between elderly male and female patients with a fall-related hip fracture and
elective hip surgery.
Study design
Prospective, randomized controlled, single-centre, observational study.
Setting: Department of General Surgery, division of Traumatology, department of
Orthopedics, and department of Human Movement Sciences, Maastricht University
Medical Centre+ (MUMC+)
Intervention
n.a.
Study burden and risks
Muscle biopsies will be taken through a small (5 mm) incision, following local
anesthetics of the skin and muscle fascia, and will heal completely. The test
beverages contain dietary protein that is safe for human consumption and has
been used in previous studies.
Universiteitssingel 50
Maastricht 6200MD
NL
Universiteitssingel 50
Maastricht 6200MD
NL
Listed location countries
Age
Inclusion criteria
Hip fracture or osteoarthritis of the hip, >65 years of age, operative treatment
Healthy elderly subjects, mentally competent, age-matched with fracture patients
Exclusion criteria
- Co-morbidities and neuromuscular disorders of the lower limbs severely interacting with mobility
- Co-morbidities severely interacting with muscle metabolism of the lower limbs
- Known renal malfunction (Known renal malfunction without documented approval from nephrologist)
- Known allergy to milk, milk products and soy
- Known galactosaemia
- A life-expectancy of less than 6 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42470.068.12 |
| Other | NTR: TC 3773 |