NCT05995743: VO2drépano

VO2max & HRQoL in Children With Sickle Cell Disease

Completed Last updated 21 August 2023

What this trial tests

trial in Sickle Cell in 72 participants. Completed in 1 November 2022.

Timeline

1 November 2021

Primary endpoint
1 November 2022

1 November 2022

Quick facts

Lead sponsor	University Hospital, Montpellier
Status	Completed
Study type	OBSERVATIONAL
Enrollment	72
Start date	1 November 2021
Primary completion	1 November 2022
Estimated completion	1 November 2022
Sites	1 location across France

Conditions studied

• Sickle Cell — all drugs for Sickle Cell →
• Children — all drugs for Children →

Sponsor

University Hospital, Montpellier

Who can join

Adults 6 to 17, any sex, with Sickle Cell or Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sickle cell disease is the most common inherited genetic disorder, accounting for 300,000 births worldwide per year. It is caused by an autosomal recessive mutation of the β-globin gene, responsible for an abnormal hemoglobin, the main protein in red blood cells, responsible for transporting oxygen from the lungs to the tissues. The abnormal hemoglobin, known as "Sickle" or S, deforms the red blood cell, causing chronic hemolytic anemia, organ damage (heart, spleen, etc.) and vaso-occlusive crises. Therapeutic progress and specialised patient follow-up have considerably improved the vital and functional prognosis of children and adolescents with sickle cell disease. Physical fitness, measured during a cardiorespiratory exercise test (CPET), is used to determine maximal oxygen uptake (VO2max). Patients with sickle cell disease have a multifactorial limitation of exercise tolerance, which may affect their physical fitness. Authors have shown that VO2max is impaired in children and adolescents with sickle cell disease, independently of their baseline hemoglobin level. Yet VO2max is a key determinant of health-related quality of life (HRQoL) in patients being monitored for a chronic disease. In the past, our team has contributed to the assessment of HRQoL in several groups of pediatric patients suffering from chronic disease (congenital heart disease, PAH). To date, the link between impaired physical fitness and HRQoL has not been demonstrated in sickle cell children. The pathophysiological determinants of reduced physical capacity and exercise tolerance in sickle cell patients have also not been fully elucidated. Studying these factors will enable us to propose appropriate treatment in the future, with the aim of improving physical fitness and HRQoL in children and adolescents with sickle cell disease.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Aerobic physical capacity and health-related quality of life in children with sickle cell disease.
   Laurent-Lacroix C, Vincenti M, Matecki S, Mahé P, et al · · 2024 · cited 2× · PMID 38491141 · DOI 10.1038/s41390-024-03143-1
2. Aerobic physical capacity and health-related quality of life in children with sickle cell disease
   Laurent-Lacroix C, Vincenti M, Matecki S, Mahé P, et al · · 2023 · DOI 10.21203/rs.3.rs-3315692/v1