Actively Recruiting
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
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-02-12
120
Participants Needed
1
Research Sites
208 weeks
Total Duration
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AI-Summary
What this Trial Is About
Sickle cell disease (SCD) is a common inherited blood disorder marked by chronic anemia, painful vaso-occlusive crises (VOC), and damage to multiple organs. This condition causes fatigue and poor physical fitness, leading to a sedentary lifestyle among patients. Recent research suggests that when carefully managed, regular moderate-intensity endurance exercise can be safe and beneficial for SCD patients, improving their physical ability. This study is a large, long-term controlled trial including both adults and children with SCD, aiming to confirm these benefits and evaluate the impact on clinical outcomes over one year. Participants are assigned to one of three groups: a control group maintaining their usual inactive lifestyle, a group performing 52 weeks of out-of-hospital physical activity, and a group undergoing an initial 8 weeks of in-hospital endurance training three times a week followed by 44 weeks of out-of-hospital activity. The exercise program is tailored using blood lactate and heart rate measurements during incremental cycling tests to set appropriate training intensities. The study includes a screening visit, initial evaluations, and follow-up assessments at 6 and 12 months. During the study, participants will undergo physical evaluations, blood tests, and exercise tests to monitor their fitness and health status. Researchers will track the number of painful crises requiring hospitalization, exercise capacity, muscle metabolism, and other clinical parameters over 12 months. Safety and adherence will be monitored throughout. The study aims to determine if regular, adapted physical activity can reduce hospitalizations and improve quality of life in patients living with SCD.
CONDITIONS
Brief 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 diagnosed with sickle cell disease (HbSS or HbS-βthal0)
- Affiliated with a social security system
- Provided written informed consent
- Stable condition at study start: at least 1 month after an acute or chronic event or 3 months after a blood transfusion
- Hospitalized at least once for vaso-occlusive crisis in the last 3 years
You will not qualify if you...
- Unlikely to adhere to the study protocol
- Currently doing more than 1 hour per week of moderate-intensity physical activity
- Having a chronic inflammatory or infectious disease
- Having an unresolved condition less than 1 month old
- Hospitalized for cardiac decompensation in the last 12 months
- Taking anticoagulants or having a pacemaker/defibrillator
- Pregnant or breastfeeding
- Under judicial or administrative custody or guardianship
- Unable to understand the study or give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants undergo initial assessments including an inclusion visit and a physical evaluation to establish baseline clinical and physical fitness status.
2 visits (in-person)
Duration - 52 weeks
Participants either maintain their usual inactive lifestyle or engage in endurance training and physical activity, including hospital-based and out-of-hospital sessions depending on group assignment.
Regular sessions as per group assignment, including 3 in-hospital training sessions per week for 8 weeks for some participants, plus ongoing out-of-hospital activity
Duration - 1 week
Participants are evaluated to assess progress in clinical profile, physical fitness, and quality of life at the halfway point of the study.
2 visits (in-person)
Duration - 1 week
Participants undergo final assessments similar to initial evaluations to measure outcomes at the end of the 52-week period.
2 visits (in-person)
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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