- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01906203
Evaluation of Indices of Body Composition During Ultramarathon : Measure by Body Bioelectrical Impedance (IMPETRAIL)
November 25, 2014 updated by: University Hospital, Clermont-Ferrand
Prospective cohort, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis.
Study Overview
Status
Completed
Conditions
Detailed Description
Prospective, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis (phase angle, fat mass, muscle mass, fat-free mass, body water) before and after ultramarathon.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Clermont-Ferrand, France, 63003
- Chu Clermont-Ferrand
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participation to ultramarathon
Exclusion Criteria:
- pregnancy women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ultramarathon
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Difference of fat-free mass, using bioelectrical impedance analysis
Time Frame: before and after ultramarathon of 105 km (at day 1)
|
before and after ultramarathon of 105 km (at day 1)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Difference of phase angle, using bioelectrical impedance analysis
Time Frame: at day 1(before and after ultramarathon)
|
at day 1(before and after ultramarathon)
|
|
Correlation between order in the course,duration of course and indices of body composition
Time Frame: at day 1 (during ultramarathon of 105 km)
|
at day 1 (during ultramarathon of 105 km)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
July 11, 2013
First Submitted That Met QC Criteria
July 19, 2013
First Posted (Estimate)
July 24, 2013
Study Record Updates
Last Update Posted (Estimate)
November 26, 2014
Last Update Submitted That Met QC Criteria
November 25, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- CHU-0163
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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