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Effects of Unloading on Muscle Mass

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00936039
First Posted: July 9, 2009
Last Update Posted: July 2, 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):
Maastricht University Medical Center
  Purpose
In the present study, the effects of 3 weeks of unloading on muscle mass and muscle fiber characteristics will be determined. In addition, the effects of 6 weeks of recovery will be assessed.

Condition Intervention
Immobilization Physical Inactivity Behavioral: unloading

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Immobilization on Myocellular Characteristics in Healthy, Young Males

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • muscle mass, muscle fiber size [ Time Frame: 1 week before unloading; immediately (1 day) after unloading and 6 weeks after unloading ]

Secondary Outcome Measures:
  • muscle strength [ Time Frame: 1 week before unloading; immediately (1 day) after unloading and 6 weeks after unloading ]

Enrollment: 15
Study Start Date: October 2009
Study Completion Date: June 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: unloading
2 weeks of unloading
Behavioral: unloading
2 weeks of unloading of a single leg

  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:

  • Healthy
  • BMI < 30 kg/m2

Exclusion Criteria:

  • Use of medication that may affect haemostasis
  • Subjects with (recent) musculoskeletal/orthopaedic disorders known to affect the outcome of the study or that compromise their ability to walk with crutches
  • Subjects with metal implants in their lower limbs
  • Subjects with known cardiovascular and/or haemostasis disorders
  • Subjects with known severe hypertension
  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): NCT00936039


Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands, 6200MD
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Luc JC van Loon, PhD Maastricht UMC
  More Information

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00936039     History of Changes
Other Study ID Numbers: MEC-09-3-011
First Submitted: July 6, 2009
First Posted: July 9, 2009
Last Update Posted: July 2, 2013
Last Verified: July 2013