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

NCT06823219 | Recruiting

• 1 other identifier: APHP230822
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sickle Cell Disease

Keywords

sickle cell disease; , endurance training

Outcome Measures

Primary Outcomes (2)

• Number of vaso-occlusive crises (VOCs) with hospitalisation

  determine the hospitalization rate for vaso-occlusive crisis

  12 months

• Exercise capacity and muscle metabolism and characteristics

  the change from baseline in the workload at first lactate threshold. A blood sample (7 µL) will be taken from the earlobe and immediately analysed (in less than 20 seconds, Lactate Scout+, EKF Diagnostics) to determine the blood lactate concentration (\[lactate\]b). Exercise should be stopped when a \[lactate\]b of 4 mmol/L is reached

  12 months

Secondary Outcomes (10)

• Duration of hospitalisation

  12 months

• Median time from the initiation of "treatment" (training or habitual (inactive) lifestyle) to the first and second hospitalised VOC

  12 months

• Number of acute chest syndromes (ACS)

  12 months

• Days of school and job absenteeism

  12 months

• Analgesic intake

  12 months

Study Arms (2)

trained arm

EXPERIMENTAL

Groupe 2: 52 weeks of out-of-hospital physical activity (The patients of the trained arm with a V̇O2 at SL2 \>75% of the predicted V̇O2 at SL2) Groupe 3: 8 weeks of in hospital endurance training 3/weeks and 44 weeks of out- of-hospital physical activity (Patients identified as presenting severity criteria )

Other: endurance training program

untrained arm

NO INTERVENTION

Groupe 1: 52 weeks of unchanged rhythm

Interventions

endurance training program OTHER

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

trained arm

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 with an intercurrent condition unresolved for less than a month
• Patients hospitalised for cardiac decompensation during the last 12 months
• 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
• Patients unable to understand the objectives and conditions of the study and unable to give cons

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, 94000, France

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomization will be in a 1:2 ratio between the untrained and trained arms, respectively. Randomization will be stratified on treatment by hydroxyurea, gender and age.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomised, controlled trial, multicentric, open label

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 12, 2025
• Study Start: September 1, 2024
• Primary Completion: October 1, 2024
• Study Completion (Estimated): October 1, 2028
• Last Updated: February 12, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)