Long-term Endurance Training in Sickle Cell Disease Patients: Impact on Clinical Profile, Physical Fitness, and Quality of Life.
About this study
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.
- Condition
- Sickle Cell Disease
- Tested
- endurance training program
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Who can join
- Age
- 15 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 9
- Minimum age: 15 years
- Study condition: Sickle Cell Disease
- 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 9
- 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
1 site, 1 recruiting
Henri Mondor Hospital
Créteil, France
Potential match only. Final eligibility is determined by the study team.