CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Exercise on ergocycleother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04028791
NCT04028791N/ACompleted

Metabolic and Vascular Response to Exercise in Sickle Cell Trait Carriers: Effect of Hot Environment

University of the French West Indies and French Guiana·interventional·Posted Jul 23, 2019·Updated Jul 23, 2019

In Brief

A clinical study evaluating Exercise on ergocycle for Sickle Cell Trait and 2 related conditions. Completed, enrolled 21 participants across 1 site.

Detailed Summary

The heterozygous form of sickle cell disease is clinically asymptomatic. Nevertheless, it was observed that, the sickle cell trait is associated with serious medical complications especially during intense physical efforts. Moreover, the exposure to a hot environment (tropical climate) is suspected to be a determining factor in the occurrence of these medical complications. However, the relationship between sickle cell trait and death during effort is not well established. Furthermore, the cascade of events that usually cause sickle cell crisis such as red blood cells sickling and rhabdomyolysis and which affect microcirculation are not known. Our main objective in this study is to verify whether young healthy active men with sickle cell trait have reactive hyperemia to their hemoglobinemic condition during exercise; to identify the contribution of hot environment on these possible disturbances; and to determine underlying mechanisms. In addition, disturbances in the regulation of glucose metabolism in healthy subjects under hot environment have been reported, marked by a significant increase in postprandial blood glucose. Therefore, this project is also intended to assess the contribution of the disturbance of glycoregulation during exercise under hot environment in active sickle cell trait carriers. The imbalance of pro and anti oxidant agents, the adhesion and inflammation markers will also be evaluated. Results of this study will allow a better understanding of physio-pathological mechanisms leading to vascular accidents during exercise under tropical climate in young healthy sickle cell trait carriers; and to identify physical activity programs and nutritional interventions adapted to patients with sickle cell disease under hot environment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGuadeloupe

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 23, 2019
Enrollment StartSep 25, 2017
Primary CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.9 years ago

Interventions

Exercise on ergocycleother

The exercise includes 15 minutes of warm up, then participants will be asked to pedal as fast as possible for 6 seconds. The test of 6 seconds will be repeated twice or more with recovery each time