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Effects of Unloading on Muscle Mass

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00936039
First received: July 6, 2009
Last updated: May 30, 2012
Last verified: May 2012
History of Changes
  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: Open Label
Primary Purpose: Basic Science
Official Title: The Effect of Immobilization on Myocellular Characteristics in Healthy, Young Males

Resource links provided by NLM:

MedlinePlus related topics: Dietary Fiber
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • muscle strength [ Time Frame: 1 week before unloading; immediately (1 day) after unloading and 6 weeks after unloading ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: October 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (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

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

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00936039     History of Changes
Other Study ID Numbers: MEC-09-3-011
Study First Received: July 6, 2009
Last Updated: May 30, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

ClinicalTrials.gov processed this record on May 23, 2013