Actively Recruiting

Phase Not Applicable
Age: 15Years +
All Genders
NCT06823219

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

Age: 15Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Henri Mondor Hospital

Créteil, France, 94000

Actively Recruiting

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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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