Long-term Endurance Training in Sickle Cell Disease Patients: Impact on Clinical Profile, Physical Fitness, and Quality of Life.
Recruiting · NCT06823219 · Interventional (participants receive a specific treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Sickle cell disease (SCD), the most common genetic disease worldwide and in France, is an inherited haemoglobinopathy characterised by chronic haemolytic anaemia, vaso-occlusive crisis (VOC), acute pain, and multi-organ damage. Due to anaemia and multiple pulmonary, cardiac, endothelial, muscle, and metabolic dysfunctions, fatigue and poor physical capacity are common in SCD patients and constitute the primary reason for a sedentary lifestyle. However, recent findings demonstrated in the first randomised, controlled, and prospective study implementing endurance training in SCD that, when adequately calibrated, regular moderate-intensity endurance training is not only safe but also beneficial for patients (primary outcome: improvement of physical ability). This pivotal randomised, controlled, prospective study is designed to prove, on a large multicentre cohort, adult and paediatric, including patients with complications and over a longer period (one year). The objective of the study is to demonstrate the efficacy of participating in a program of regular physical activity to reduce the rate of vaso-occlusive crises requiring hospitalisation and to improve physical ability in patients with SCD.
Who can take part
Inclusion criteria
- Aged over 15 years and 3 months
- Male or female
- Patients with sickle cell disease (HbSS or HbS-βthal0)
- Affiliated to a social security system
- Having freely given their written consent after having been informed of the purpose, the procedure and the potential risks involved
- Patients in stabilised condition at the start of the experiment: at least 1 month after an acute chronic event or at least 3 months after a blood transfusion.
- Patients hospitalised for vaso-occlusive crisis at least once in the last 3 years
Exclusion criteria
- Patient whose adherence to the protocol is unlikely according to the investigator
- Patients who already partake in regular physical activity (more than 1 hour of moderate-intensity physical activity per week)
- Patients with a chronic inflammatory and/or infectious pathology
- Patients with an intercurrent condition unresolved for less than a month
- Patients hospitalised for cardiac decompensation during the last 12 months
- Patients on anticoagulant treatment or with a pacemaker/defibrillator
- Pregnant patients / breastfeeding woman
- Patients deprived of liberty by judicial or administrative decision or patient under guardianship
- Patients unable to understand the objectives and conditions of the study and unable to give cons
Where it is running
1 location listed.
- Henri Mondor Hospital - Créteil, France