NCT06823219 Long-term Endurance Training in Sickle Cell Disease Patients: Impact on Clinical Profile, Physical Fitness, and Quality of Life.
| NCT ID | NCT06823219 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Sickle Cell Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2024-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-09-01 with a primary completion date of 2024-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT06823219 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying Sickle Cell Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06823219 currently recruiting?
Yes, NCT06823219 is actively recruiting participants. Visit ClinicalTrials.gov or contact Assistance Publique - Hôpitaux de Paris to inquire about joining.
Where is the NCT06823219 trial being conducted?
This trial is being conducted at Créteil, France.
Who is sponsoring the NCT06823219 clinical trial?
NCT06823219 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 120 participants.
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