To investigate whether twice daily local (calf muscle) NMES attenuates muscle loss during 2 weeks of unilateral ankle immobilization due to an ankle fracture.
ID
Source
Brief title
Condition
- Other condition
- Protein and amino acid metabolism disorders NEC
- Muscle disorders
Synonym
Health condition
Muscle metabolism
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Calf muscle (gastrocnemius) cross sectional area (CSA).
Secondary outcome
Type I and II muscle fiber CSA and SC content, intramuscular triglyceride
content and mRNA and protein expression of anabolic signaling proteins.
Background summary
Situations such as fractures of the lower extremity can necessitate a prolonged
period of muscle disuse due to immobilization in otherwise healthy individuals.
Long-term immobilization of the lower extremity has shown to cause significant
reductions in skeletal muscle mass, already occurring during the early stages
of disuse. Accordingly, feasible strategies for attenuating this loss of muscle
during disuse need to be pursued. Local neuromuscular electrical stimulation
(NMES) offers such a potential strategy but, as yet, remains untested during
prolonged muscle disuse in a clinical setting. Therefore, the aim of the
present study is to investigate whether twice daily local (calf muscle) NMES
attenuates muscle loss during 2 weeks of one legged ankle immobilization due to
an ankle fracture.
Study objective
To investigate whether twice daily local (calf muscle) NMES attenuates muscle
loss during 2 weeks of unilateral ankle immobilization due to an ankle
fracture.
Study design
Randomized, parallel (two groups) study design.
Intervention
Twice daily neuromuscular electrical stimulation (NMES) or no intervention.
Study burden and risks
The risks involved in participating in this experiment are minimal. Patients
will undergo protocol treatment for ankle fractures with or without twice daily
NMES during the immobilization period. Muscle biopsies will be taken through a
small (5 mm) incision, following local anesthetics of the skin and muscle
fascia, and will heal completely. Muscle biopsies will only be obtained by an
experienced physician.
Universiteitssingel 50 - room 2.208
Maastricht 6229 ER
NL
Universiteitssingel 50 - room 2.208
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
- Unilateral closed ankle fracture (Weber type A, B or C)
- Aged from 18-65 years
- BMI above 18.5 and below 30 kg/m2
- Undergoing surgical treatment
Exclusion criteria
- Additional fractures beside ankle fracture (e.g. multi-trauma following a car accident)
- Use of oral anticoagulants such as vitamin K-antagonists (e.g. acenocoumarol and fenprocoumon) and direct-acting or new oral anticoagulants (e.g. apixaban, dabigatran and rivaroxaban)
- Any family history of thrombosis
- All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis)
- Myocardial infarction within the last 3 years
Design
Recruitment
Medical products/devices used
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 | NL50385.068.14 |