The Effects of Daily Neuromuscular Electrical Stimulation on Muscle Mass During Long-term Unilateral Ankle Immobilization in Adults With Ankle Fractures
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Percentage change in calf muscle cross sectional area
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral closed ankle fracture (Weber type A, B or C)
- •Aged from 18-65 years
- •18.5 < BMI < 30 kg/m2
- •Undergoing surgical treatment
排除标准
- •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
研究组 & 干预措施
NMES group
Patients will receive twice daily sessions of neuromuscular electrical stimulation (NMES).
干预措施: Neuromuscular Electrical Stimulation (NMES) (Device)
Control group
Patients will receive daily visits by the investigator to check progress.
结局指标
主要结局
Percentage change in calf muscle cross sectional area
时间窗: 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.
次要结局
- 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.)
- 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.)
- 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.)
研究者
Lex Verdijk
Prof. Dr. Luc. J.C. van Loon
Maastricht University Medical Center