NCT06823219Recruiting
Long-term Endurance Training in Sickle Cell Disease Patients: Impact on Clinical Profile, Physical Fitness, and Quality of Life.
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
Source: ClinicalTrials.gov · Last updated 12 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 6 Feb 2024
- Start date
- 1 Sept 2024
- Primary completion date
- 1 Oct 2024
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Sickle cell disease
- NCT number
- NCT06823219
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 Sept 2024 to the primary completion date, 1 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with an intercurrent condition unresolved for less than a month
- Patients hospitalised for cardiac decompensation during the last 12 months
- Patients unable to understand the objectives and conditions of the study and unable to give cons
Other
- Patient whose adherence to the protocol is unlikely according to the investigator
- Patients who already partake in regular physical activity (more than 1 hour of moderate-intensity physical activity per week)
- Patients with a chronic inflammatory and/or infectious pathology
- Patients on anticoagulant treatment or with a pacemaker/defibrillator
- Pregnant patients / breastfeeding woman
- Patients deprived of liberty by judicial or administrative decision or patient under guardianship
Who the study is looking for
- 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
Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Henri Mondor Hospital Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.