Immobilization, Muscle Disuse Atrophy
Conditions
Brief summary
Rationale: Situations such as fractures of the lower extremity can necessitate a prolonged period of 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. Objective: To investigate whether twice daily local (gastrocnemius/soleus) NMES attenuates muscle loss during 2 weeks of unilateral ankle immobilization. Study design: Randomized, parallel (two groups) study design. Study population: 30 adults (18-65 y) with any form of closed ankle fractures needing surgical treatment. Intervention: Twice daily neuromuscular electrical stimulation (NMES) or no intervention. Main study parameters/endpoints: Primary: Calf muscle (gastrocnemius) cross sectional area (CSA) as determined by CT scan. Secondary: type I and II muscle fiber CSA and SC content, intramuscular triglyceride content and mRNA and protein expression of anabolic signaling proteins.
Interventions
DEVICENeuromuscular Electrical Stimulation (NMES)
The protocol will consist of a warm-up period (5 min), a stimulation period (30min), and a cooling-down period (5min). Stimulation will be provided by an Enraf Nonius TensMed S84 stimulation device.
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Unilateral closed ankle fracture (Weber type A, B or C) * Aged from 18-65 years * 18.5 \< BMI \< 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 outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in calf muscle cross sectional area | Baseline measurements will be performed at the day of the surgical intervention for the ankle fracture. Post measurements will be performed at the last day of the subsequent 2-week period of immobilization with a lower leg cast. | Measured by a single slice CT-scan of the calf muscle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in type I and II muscle fiber cross sectional area | Baseline measurements will be performed at the day of the surgical intervention for the ankle fracture. Post measurements will be performed at the last day of the subsequent 2-week period of immobilization with a lower leg cast. | Measured by immunohistochemical analyses of the muscle biopsies. |
| Percentage change in type I and II muscle fiber satellite cell content | Baseline measurements will be performed at the day of the surgical intervention for the ankle fracture. Post measurements will be performed at the last day of the subsequent 2-week period of immobilization with a lower leg cast. | Measured by immunohistochemical analyses of the muscle biopsies. |
| Percentage change in type I and II muscle fiber intramuscular triglyceride content | Baseline measurements will be performed at the day of the surgical intervention for the ankle fracture. Post measurements will be performed at the last day of the subsequent 2-week period of immobilization with a lower leg cast. | Measured by immunohistochemical analyses of the muscle biopsies. |
Countries
Netherlands
Outcome results
None listed