NCT01906203

Brief Summary

Prospective cohort, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 26, 2014

Status Verified

November 1, 2014

Enrollment Period

1 month

First QC Date

July 11, 2013

Last Update Submit

November 25, 2014

Conditions

Healthy Volunteers

Keywords

Ultramarathonbioelectrical impedancePhase-Angle

Outcome Measures

Primary Outcomes (1)

  • Difference of fat-free mass, using bioelectrical impedance analysis

    before and after ultramarathon of 105 km (at day 1)

Secondary Outcomes (2)

  • Difference of phase angle, using bioelectrical impedance analysis

    at day 1(before and after ultramarathon)

  • Correlation between order in the course,duration of course and indices of body composition

    at day 1 (during ultramarathon of 105 km)

Study Arms (1)

ultramarathon

EXPERIMENTAL
Device: body bioelectrical impedance performed by Z-Métrix (class IIa) - BIOPARHOM 12 allée des lacs de garde, Savoie Technolac BP 238, 73374 Bourget du lac, France

Interventions

body bioelectrical impedance performed by Z-Métrix (class IIa) - BIOPARHOM 12 allée des lacs de garde, Savoie Technolac BP 238, 73374 Bourget du lac, FranceDEVICE
ultramarathon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participation to ultramarathon

You may not qualify if:

  • pregnancy women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Study Officials

  • Sébastien PERBET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2013

First Posted

July 24, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2013

Study Completion

September 1, 2013

Last Updated

November 26, 2014

Record last verified: 2014-11

Locations

FR(1)