Back to resultsElectrical Stimulation During Immobilization (ESDIM)
Primary Purpose
Disuse Atrophy, Immobilization, Neuromuscular Electrical Stimulation
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
immobilization
Sponsored by
About this trial
This is an interventional basic science trial for Disuse Atrophy
Eligibility Criteria
Inclusion Criteria:
- Male
- Aged from 18-35 years
- 18.5 < BMI < 30 kg/m2
Exclusion Criteria:
- Smoking
- Performing regular resistance training in the previous 6 months
- Hypertension (according to WHO criteria) [46] and/or cardiovascular disease
- Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
- Use of any prescribed medication
- Type 2 diabetes mellitus
- 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
- Use of anti-coagulants
Sites / Locations
- Maastricht University Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Immobilization with NMES
Immobilization without NMES
Arm Description
Immobilization with daily NMES
Immobilization without daily NMES
Outcomes
Primary Outcome Measures
muscle mass, muscle fiber size
Secondary Outcome Measures
muscle strength measured by quadriceps 1-Repetition Maximum by Leg Extension
Full Information
NCT ID
NCT01513486
First Posted
January 6, 2012
Last Updated
May 20, 2013
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01513486
Brief Title
Electrical Stimulation During Immobilization
Acronym
ESDIM
Official Title
The Effects of Daily Neuromuscular Electrical Stimulation on Muscle Mass During Short-term One-legged Knee Immobilization in Healthy Young Men
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In the present study, the effects of 5 days of lower limb immobilization with or without daily neuromuscular electrical stimulation on muscle mass and muscle fiber characteristics will be determined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disuse Atrophy, Immobilization, Neuromuscular Electrical Stimulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immobilization with NMES
Arm Type
Experimental
Arm Description
Immobilization with daily NMES
Arm Title
Immobilization without NMES
Arm Type
Placebo Comparator
Arm Description
Immobilization without daily NMES
Intervention Type
Behavioral
Intervention Name(s)
immobilization
Primary Outcome Measure Information:
Title
muscle mass, muscle fiber size
Time Frame
three days before immobilization, and directly after immobilization (day of cast removal; day 6)
Secondary Outcome Measure Information:
Title
muscle strength measured by quadriceps 1-Repetition Maximum by Leg Extension
Time Frame
three days before immobilization, and directly after immobilization (day of cast removal; day 6)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male
Aged from 18-35 years
18.5 < BMI < 30 kg/m2
Exclusion Criteria:
Smoking
Performing regular resistance training in the previous 6 months
Hypertension (according to WHO criteria) [46] and/or cardiovascular disease
Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
Use of any prescribed medication
Type 2 diabetes mellitus
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
Use of anti-coagulants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc JC van Loon, PhD
Organizational Affiliation
Maastricht UMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
Country
Netherlands
12. IPD Sharing Statement
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Electrical Stimulation During Immobilization
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