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RECRUITING
NCT06823219
NA

Long-term Endurance Training in Sickle Cell Disease Patients: Impact on Clinical Profile, Physical Fitness, and Quality of Life.

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

15 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-09-01

Completion Date

2028-10-01

Last Updated

2025-02-12

Healthy Volunteers

No

Interventions

OTHER

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

Locations (1)

Henri Mondor Hospital

Créteil, France