Neuromuscular Electrical Stimulation During Immobilization Due to Ankle Fractures

NCT02469506 | Terminated DMC

• 1 other identifier: METC 14-3-050
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Immobilization; Muscle Disuse Atrophy

Outcome Measures

Primary Outcomes (1)

• Percentage change in calf muscle cross sectional area

  Measured by a single slice CT-scan of the calf muscle.

  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.

Secondary Outcomes (3)

• 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.

Study Arms (2)

NMES group

EXPERIMENTAL

Patients will receive twice daily sessions of neuromuscular electrical stimulation (NMES).

Device: Neuromuscular Electrical Stimulation (NMES)

Control group

NO INTERVENTION

Patients will receive daily visits by the investigator to check progress.

Interventions

Neuromuscular Electrical Stimulation (NMES) DEVICE

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.

NMES group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral closed ankle fracture (Weber type A, B or C)
• Aged from 18-65 years
• \< BMI \< 30 kg/m2
• Undergoing surgical treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6229ER, Netherlands

Location

MeSH Terms

Conditions

Muscular Disorders, Atrophic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Luc van Loon, Prof

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Luc. J.C. van Loon

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 11, 2015
• Study Start: February 1, 2015
• Primary Completion: August 29, 2016
• Study Completion: August 30, 2016
• Last Updated: September 6, 2017

Record last verified: 2017-09

Locations

NL (1)