Clinical Trial: Neuromuscular Electrical Stimulation During Immobilization Due to Ankle Fractures

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: The Effects of Daily Neuromuscular Electrical Stimulation on Muscle Mass During Long-term Unilateral Ankle Immobilization in Adults With Ankle Fractures

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.


Detailed Summary:
Sponsor: Maastricht University Medical Center

Current Primary Outcome: Percentage change in calf muscle cross sectional area [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage change in type I and II muscle fiber cross sectional area [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Maastricht University Medical Center

Dates:
Date Received: June 4, 2015
Date Started: February 2015
Date Completion:
Last Updated: August 29, 2016
Last Verified: August 2016