Electrical Stimulation During Immobilization (ESDIM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lex Verdijk, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01513486
First received: January 6, 2012
Last updated: May 20, 2013
Last verified: May 2013
  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: 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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

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
Atrophy
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 19, 2014