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Electrical Stimulation During Immobilization (ESDIM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01513486
First Posted: January 20, 2012
Last Update Posted: May 22, 2013
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.
Information provided by (Responsible Party):
Lex Verdijk, Maastricht University Medical Center
  Purpose
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.

Condition Intervention
Disuse Atrophy Immobilization Neuromuscular Electrical Stimulation Behavioral: immobilization

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Daily Neuromuscular Electrical Stimulation on Muscle Mass During Short-term One-legged Knee Immobilization in Healthy Young Men

Further study details as provided by Lex Verdijk, Maastricht University Medical Center:

Primary Outcome Measures:
  • muscle mass, muscle fiber size [ Time Frame: three days before immobilization, and directly after immobilization (day of cast removal; day 6) ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 24
Study Start Date: March 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immobilization with NMES
Immobilization with daily NMES
Behavioral: immobilization
Placebo Comparator: Immobilization without NMES
Immobilization without daily NMES
Behavioral: immobilization

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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): NCT01513486


Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Luc JC van Loon, PhD Maastricht UMC
  More Information

Responsible Party: Lex Verdijk, Assistant Professor, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01513486     History of Changes
Other Study ID Numbers: MEC 11-3-073
First Submitted: January 6, 2012
First Posted: January 20, 2012
Last Update Posted: May 22, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Atrophy
Muscular Disorders, Atrophic
Pathological Conditions, Anatomical
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases