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

Primary Purpose

Immobilization, Muscle Disuse Atrophy

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Neuromuscular Electrical Stimulation (NMES)
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Immobilization

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NMES group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percentage change in calf muscle cross sectional area
Measured by a single slice CT-scan of the calf muscle.

Secondary Outcome Measures

Percentage change in type I and II muscle fiber cross sectional area
Measured by immunohistochemical analyses of the muscle biopsies.
Percentage change in type I and II muscle fiber satellite cell content
Measured by immunohistochemical analyses of the muscle biopsies.
Percentage change in type I and II muscle fiber intramuscular triglyceride content
Measured by immunohistochemical analyses of the muscle biopsies.

Full Information

First Posted
June 4, 2015
Last Updated
September 4, 2017
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02469506
Brief Title
Neuromuscular Electrical Stimulation During Immobilization Due to Ankle Fractures
Acronym
ANKL-ES
Official Title
The Effects of Daily Neuromuscular Electrical Stimulation on Muscle Mass During Long-term Unilateral Ankle Immobilization in Adults With Ankle Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
Minimal to no inclusion.
Study Start Date
February 2015 (undefined)
Primary Completion Date
August 29, 2016 (Actual)
Study Completion Date
August 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immobilization, Muscle Disuse Atrophy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NMES group
Arm Type
Experimental
Arm Description
Patients will receive twice daily sessions of neuromuscular electrical stimulation (NMES).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients will receive daily visits by the investigator to check progress.
Intervention Type
Device
Intervention Name(s)
Neuromuscular Electrical Stimulation (NMES)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage change in calf muscle cross sectional area
Description
Measured by a single slice CT-scan of the calf muscle.
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.
Secondary Outcome Measure Information:
Title
Percentage change in type I and II muscle fiber cross sectional area
Description
Measured by immunohistochemical analyses of the muscle biopsies.
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.
Title
Percentage change in type I and II muscle fiber satellite cell content
Description
Measured by immunohistochemical analyses of the muscle biopsies.
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.
Title
Percentage change in type I and II muscle fiber intramuscular triglyceride content
Description
Measured by immunohistochemical analyses of the muscle biopsies.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc van Loon, Prof
Organizational Affiliation
Maastricht University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229ER
Country
Netherlands

12. IPD Sharing Statement

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Neuromuscular Electrical Stimulation During Immobilization Due to Ankle Fractures

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