Prognostic Value of Functional Exercise Test (EFX) in Cystic Fibrosis (EFX)
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|ClinicalTrials.gov Identifier: NCT02994017|
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Other: cardiopulmonary exercise testing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Prognostic Value of Functional Exercise Test (EFX) in Cystic Fibrosis|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
|cystic fibrosis patients||
Other: cardiopulmonary exercise testing
The Cardiopulmonary exercise testing (CPET) was performed at the beginning of the study, the same at each center. Each patient underwent a symptom-limited incremental exercise test on an ergometric bicycle (Ergoline-Ergometrics 800®). The protocol included a warm-up period of 3 min at 20 W followed by a progressively increasing work rate (WR) in a ramp fashion and then 3 min recovery. The ramped WR increment was individualized (range,8-30 W/min). during exercise, heart rate (HR) was monitored continuously by 12-lead ECG, and arterial oxygen saturation (SpO2) was measured by pulse oximetry (Nellcor N-395). The expired gases were analyzed with an Ergocard®, focusing on oxygen consumption(VO2), carbon dioxide production (VCO2), minute ventilation (VE), and tidal volume (VT).
- Survival [ Time Frame: at five years ]the survival is defined by the occurrence of death or lung transplantation.
- 6 minute walking distance [ Time Frame: Every 12 months during 5 years ]
- body mass index calculation [ Time Frame: Every 12 months during 5 years ]
- sputum sample culture [ Time Frame: Every 12 months during 5 years ](a descriptive analysis of Haemophilus influenzae, Staphylococcus aureus, Pseudomonas aeruginosa,Burkholderia cepacia streptococci in the bacterial flora of sputum)
- pulmonary function testing with DLCO [ Time Frame: Every 12 months during 5 years ]diffusing lung capacity for carbon monoxide.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994017
|Contact: Anne Prevotat, MDfirstname.lastname@example.org|
|Hôpital Calmette, CHRU||Recruiting|
|Principal Investigator: Anne Prevotat, MD|
|Principal Investigator:||Anne Prevotat, MD||University Hospital, Lille|