Evaluation of a Long-term Endurance Training Program in Patients With Sickle Cell Disease: Benefits on Clinical Profile, Physical Fitness and Quality of Life of Patients

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 15
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Henri Mondor Hospital
RECRUITING
Créteil
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2028-10-01
Participants
Target number of participants: 120
Treatments
Experimental: trained arm
Groupe 2: 52 weeks of out-of-hospital physical activity (The patients of the trained arm with a V̇O2 at SL2 \>75% of the predicted V̇O2 at SL2) Groupe 3: 8 weeks of in hospital endurance training 3/weeks and 44 weeks of out- of-hospital physical activity (Patients identified as presenting severity criteria )
No_intervention: untrained arm
Groupe 1: 52 weeks of unchanged rhythm
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov