Evaluation of a Training Program for Homozygous Sickle Cell Disease Patients

NCT02571088 | Completed

• 2 other identifiers: 14080302014-A00334-43
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 9

Brief Summary

Sickle cell disease (SCD) is the most frequent inherited disease in the world. Literature reports that SCD patients display intolerance to exercise, important muscle weakness and profound remodeling of skeletal muscle including amyotrophy and rarefied microvascular network. Because strenuous exercise induces acidosis, hemorheological alterations, endothelial activation and oxidative stress, it constitutes a potential triggering factor of sickling and vaso-occlusive crisis. As a consequence, physical activity is usually discouraged in patients with SCD. However, moderate and regular physical activity seems to be not only safe but also beneficial for SCD patients.

Conditions

Sickle Cell Hemoglobin C Disease; Hemoglobin S Disease

Keywords

Sickle Cell Hemoglobin C Disease; Sports Training; Hemoglobin S Disease; Lactate

Outcome Measures

Primary Outcomes (1)

• Power output (W) associated with the 4 mmol/L blood lactate concentration

  The blood lactate concentration curve in response to incremental exercise depends on the physical ability of patients. Endurance training is known to increase the power output (W) associated with a given blood lactate concentration. For the present study, we used the 4 mmol/L blood lactate concentration as a remarkable/singular point of the curve

  8 weeks

Secondary Outcomes (44)

• Muscle fiber types distribution (%)

  8 weeks

• perimeter (µm) of muscle fiber

  8 weeks

• surface area (µm2) of muscle fiber

  8 weeks

• satellite cell account

  8 weeks

• Creatine Kinase (CK) of muscle

  8 weeks

Study Arms (2)

Training Program

EXPERIMENTAL

The treatment will consist in an endurance training program. Only patients of the trained group will be subjected to this training program which will typically consist in 3 training sessions per week during 8 weeks i.e., 24 training sessions. Each training session will last 45 min. All training sessions will take place at the hospital and will be under medical supervision.

Other: Training Program

No Training Program

NO INTERVENTION

It will be asked to the control patients to not change their habitual physical activity during the entire period of observation

Interventions

Training Program OTHER

Each training session will last 45 min. Exercise will start by a 5-min warm-up cycling period, followed by 30 min of cycling at the power output (W) individually determined before and corresponding to the first lactate threshold corresponding approximately to 2.5 mmol/l . Then patients will cool down for 5 min. Finally, the training sessions will end by 5 min of light stretching. All training sessions will take place at the hospital and will be under the supervision of a physician. Heart rate, oxygen saturation and blood lactate concentrations will be regularly measured. Work rate will be adjusted according to the obtained results. As a safety procedure, blood lactate concentration must not exceed 4 mmol/L during the training sessions. A particular attention will be paid to the hydration of patients. Pain and fatigue will be evaluated everyday by the patients using (100 mm) visual analog scales.

Training Program

Eligibility Criteria

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

You may qualify if:

• Sickle cell disease patient (HbSS or HbS-βthal0),
• Affiliated to a Health Security program,
• Consent form signed,
• Patients in stabilized state at the onset of the experiment: at least one month after an acute adverse event and at least 3 months after a blood transfusion.

You may not qualify if:

• Patients whom adhesion/compliance to the protocol appears uncertain,
• Patients known to be affected by a chronic inflammatory or infectious pathology,
• Patients having an intercurrent infection, especially inflammatory, unsolved since less than one month,
• Patients with clinical signs of heart failure or hospitalized for cardiac decompensation during the past 12 months,
• Patients with left ventricular ejection fraction \< 50%, pulmonary arterial hypertension with tricuspid regurgitation velocity \> 2.5 m/s, atrial fibrillation, ventricular rhythm disorders during exercise, left ventricular hypertrophy (septal to lateral wall thickness ≥ 10 mm), significant valvulopathy, established coronary disease, uncontrolled hypertension,
• Patients with a treatment against cardiac arrhythmia or altering sino-atrial node activity (beta-blockers, atropine, sympathomimetic agents…),
• Patients under anti-coagulant treatment,
• Patients with pacemaker or defibrillator,
• Body Mass Index (BMI) \> 35,
• Patients with hip osteonecrosis,
• Patients with cerebral vasculopathy or history of stroke (cerebrovascular attack) with epilepsy,
• Pregnant or lactating patients,
• Homeless patients,
• Patients with the inability to understand the aims,

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Centre de Référence des Syndromes Drépanocytaires Majeurs: collaborator
• Laboratoire de Physiologie de l'Exercice: collaborator
• Claude Bernard University: collaborator

Study Sites (9)

Hopital Avicenne

Bobigny, 93000, France

Location

Centre hospitalier sud francilien

Corbeil-Essonnes, 91100, France

Location

CHU Henri MONDOR

Créteil, 94010, France

Location

CHU Kremlin-Bicêtre

Le Kremlin-Bicêtre, 93270, France

Location

Hopital Europeen Georges POMPIDOU

Paris, 75015, France

Location

Hopital Necker

Paris, 75015, France

Location

Hopital Tenon

Paris, 75020, France

Location

Centre hospitalier de Saint-Denis

Saint-Denis, 93200, France

Location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

Related Publications (3)

• Merlet AN, Feasson L, Bartolucci P, Hourde C, Schwalm C, Gellen B, Galacteros F, Deldicque L, Francaux M, Messonnier LA; EXDRE Collaborative Study Group. Muscle structural, energetic and functional benefits of endurance exercise training in sickle cell disease. Am J Hematol. 2020 Nov;95(11):1257-1268. doi: 10.1002/ajh.25936. Epub 2020 Aug 1.

  PMID: 32681734 DERIVED

• Merlet AN, Messonnier LA, Coudy-Gandilhon C, Bechet D, Gellen B, Rupp T, Galacteros F, Bartolucci P, Feasson L. Beneficial effects of endurance exercise training on skeletal muscle microvasculature in sickle cell disease patients. Blood. 2019 Dec 19;134(25):2233-2241. doi: 10.1182/blood.2019001055.

  PMID: 31742587 DERIVED

• Gellen B, Messonnier LA, Galacteros F, Audureau E, Merlet AN, Rupp T, Peyrot S, Martin C, Feasson L, Bartolucci P; EXDRE collaborative study group. Moderate-intensity endurance-exercise training in patients with sickle-cell disease without severe chronic complications (EXDRE): an open-label randomised controlled trial. Lancet Haematol. 2018 Nov;5(11):e554-e562. doi: 10.1016/S2352-3026(18)30163-7.

  PMID: 30389037 DERIVED

MeSH Terms

Conditions

Hemoglobin SC Disease; 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 Officials

• Leonard FEASSON, MD

  CHU de SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

• Laurent MESSONIER, PhD

  Université de Savoie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: October 8, 2015
• Study Start: September 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: September 13, 2021

Record last verified: 2021-09

Locations

FR (9)