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Neuromuscular Electrical Stimulation During Immobilization Due to Ankle Fractures (ANKL-ES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469506
Recruitment Status : Terminated (Minimal to no inclusion.)
First Posted : June 11, 2015
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Lex Verdijk, Maastricht University Medical Center

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.


Condition or disease Intervention/treatment Phase
Immobilization Muscle Disuse Atrophy Device: Neuromuscular Electrical Stimulation (NMES) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of Daily Neuromuscular Electrical Stimulation on Muscle Mass During Long-term Unilateral Ankle Immobilization in Adults With Ankle Fractures
Study Start Date : February 2015
Actual Primary Completion Date : August 29, 2016
Actual Study Completion Date : August 30, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NMES group
Patients will receive twice daily sessions of neuromuscular electrical stimulation (NMES).
Device: Neuromuscular 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.

No Intervention: Control group
Patients will receive daily visits by the investigator to check progress.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469506


Locations
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Netherlands
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6229ER
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Luc van Loon, Prof Maastricht University Medical Centre
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Responsible Party: Lex Verdijk, Prof. Dr. Luc. J.C. van Loon, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02469506    
Other Study ID Numbers: METC 14-3-050
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Muscular Disorders, Atrophic
Atrophy
Ankle Fractures
Pathological Conditions, Anatomical
Fractures, Bone
Wounds and Injuries
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases