Effects of Unloading on Muscle Mass

Physical Inactivity Clinical Trial

Official title:

The Effect of Immobilization on Myocellular Characteristics in Healthy, Young Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936039
• Other study ID #: MEC-09-3-011
• Status: Completed
• Phase: N/A
• First received: July 6, 2009
• Last updated: July 1, 2013
• Start date: October 2009
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Immobilization
• Physical Inactivity

Intervention

Behavioral:
• unloading
2 weeks of unloading of a single leg

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle mass, muscle fiber size		1 week before unloading; immediately (1 day) after unloading and 6 weeks after unloading	No
Secondary	muscle strength		1 week before unloading; immediately (1 day) after unloading and 6 weeks after unloading	No