Exercise and Baseline Respiratory Functional Tests Among Obese Teenagers (EFRADO)

September 17, 2018 updated by: Centre Hospitalier Universitaire de Besançon

In obese adolescents, the severity of obesity should not influence the outcome of resting PFT. The amplitudes of the rest PFT should make it possible to predict the performance achieved while exercising on a cycloergometer.

We wish to highlight the presence of a significant correlation, probably low, between some respiratory parameters at rest, and cardio-vascular parameters at the exercise.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

59

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

  • France
      • Besançon, France, 25000
        • Recruiting
        • CHU de Besançon
        • Contact:
          • Amine Sediki, Int
          • Phone Number: 0033381218135

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

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Obese teenagers with previous PFT available in the medical record

Description

Inclusion Criteria:

  • Children aged >12 y.o and <18 y.o
  • BMI > 30
  • with a previous pulmonary function test (PFT) available in the medical record

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obese teenagers
Other: Correlation between resting respiratory parameters and cardio-respiratory parameters at exercise
Correlation between resting respiratory parameters and cardio-respiratory parameters at exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between resting respiratory parameters and cardio-respiratory parameters at exercise
Time Frame: Day 1
Correlation between resting respiratory parameters: total lung capacity (TLC), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and cardio-respiratory parameters at exercise: maximal oxygen uptake (VO2 max), power achieved during incremental testing (Pmax), blood gas, at the time of the pulmonary function test.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besançon

Investigators

  • Principal Investigator: Bruno Degano, MD PhD, CHU de Besançon

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 (Actual)

August 16, 2018

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2018/390

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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