Actively Recruiting
Long-term Endurance Training in Sickle Cell Disease Patients: Impact on Clinical Profile, Physical Fitness, and Quality of Life.
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-02-12
120
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Long-term Endurance Training in Sickle Cell Disease Patients: Impact on Clinical Profile, Physical Fitness, and Quality of Life.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged over 15 years and 3 months
- Male or female
- Patients with sickle cell disease (HbSS or HbS-b2thal0)
- Affiliated to a social security system
- Having freely given written consent after being informed about the study
- Patients in stabilized condition at study start: at least 1 month after an acute event or 3 months after a blood transfusion
- Patients hospitalized for vaso-occlusive crisis at least once in the last 3 years
You will not qualify if you...
- Unlikely to adhere to the study protocol according to the investigator
- Currently engaging in regular physical activity over 1 hour per week
- Having a chronic inflammatory or infectious disease
- Having an unresolved intercurrent condition less than 1 month old
- Hospitalized for cardiac decompensation in the last 12 months
- On anticoagulant treatment or with a pacemaker/defibrillator
- Pregnant or breastfeeding
- Deprived of liberty by judicial or administrative decision or under guardianship
- Unable to understand the study objectives and give consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Henri Mondor Hospital
Créteil, France, 94000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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