NCT03675867

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 16, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 17, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

3 months

First QC Date

September 17, 2018

Last Update Submit

September 17, 2018

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (1)

  • Correlation between resting respiratory parameters and cardio-respiratory parameters at exercise

    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

Study Arms (1)

Obese teenagers

Other: Correlation between resting respiratory parameters and cardio-respiratory parameters at exercise

Interventions

Correlation between resting respiratory parameters and cardio-respiratory parameters at exerciseOTHER

Correlation between resting respiratory parameters and cardio-respiratory parameters at exercise

Obese teenagers

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Obese teenagers with previous PFT available in the medical record

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bruno Degano, MD PhD

    CHU de Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amine SEDIKI

CONTACT

0033381218135amine.sediki10@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 18, 2018

Study Start

August 16, 2018

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

September 18, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)