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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00936039
Other study ID # MEC-09-3-011
Secondary ID
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


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
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