endurance training program: Groupe 2: 52 weeks of out-of-hospital physical activity Groupe 3: 8 weeks of in hospital endurance training 3/weeks and 44 weeks of out- of-hospital physical activity
Study 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
Sex
ALL
Min age
15 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Number of vaso-occlusive crises (VOCs) with hospitalisation — 12 months determine the hospitalization rate for vaso-occlusive crisis
Exercise capacity and muscle metabolism and characteristics — 12 months the change from baseline in the workload at first lactate threshold. A blood sample (7 µL) will be taken from the earlobe and immediately analysed (in less than 20 seconds, Lactate Scout+, EKF Diagnostics) to determine the blood lactate concentration (\[lactate\]b). Exercise should be stopped when a \[lactate\]b of 4 mmol/L is reached
Trial sites (1)
Facility
City
Region
Status
Henri Mondor Hospital
Créteil
France
Recruiting
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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