Electrical Stimulation During Immobilization (ESDIM)

This study has been completed.
Information provided by (Responsible Party):
Lex Verdijk, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
First received: January 6, 2012
Last updated: May 20, 2013
Last verified: May 2013

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
Neuromuscular Electrical Stimulation
Behavioral: immobilization

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by 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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513486

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

No publications provided

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
Study First Received: January 6, 2012
Last Updated: May 20, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on April 14, 2014