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Evaluation of a Training Program for Homozygous Sickle Cell Disease Patients (EXDRE)

Primary Purpose

Sickle Cell Hemoglobin C Disease, Hemoglobin S Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Training Program
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Hemoglobin C Disease focused on measuring Sickle Cell Hemoglobin C Disease, Sports Training, Hemoglobin S Disease, Lactate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients whom adhesion/compliance to the protocol appears uncertain,
  • Patient involved in another clinical trial or within the exclusion period of a previous clinical trial,
  • 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,

Sites / Locations

  • Hopital Avicenne
  • Centre hospitalier sud francilien
  • CHU Henri MONDOR
  • CHU Kremlin-Bicêtre
  • Hopital Europeen Georges POMPIDOU
  • Hopital Necker
  • Hopital Tenon
  • Centre hospitalier de Saint-Denis
  • CHU de SAINT-ETIENNE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Training Program

No Training Program

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Muscle fiber types distribution (%)
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
perimeter (µm) of muscle fiber
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
surface area (µm2) of muscle fiber
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
satellite cell account
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Creatine Kinase (CK) of muscle
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Phosphofructokinase (PFK) of muscle
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Citrate Synthetase (CS) of muscle
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
HAD (µmol/min/g dry muscle) of muscle
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
COx (arbitrary unit, a.u.) of muscle
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Lactate Dehydrogenase (LDH) of muscle
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
isoforms (%) of muscle
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Number of capillaries per mm2 (capillary density) and in contact with a muscle fiber
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
surface area of microvessels (µm2)
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
diameter of microvessels (µm)
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
capillary tortuosity (quotient)
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
expired volume (VE)
Patients will perform a submaximal incremental exercise on a cycle ergometer. Exercise will start at 20 W and 30 W for females and males, respectively. After 2 minutes at this load, and every 2 minutes thereafter, work rate will increase by 10 W and 15 W for females and males, respectively. Total exercise duration is expected to be within 8 to 14 minutes.
oxygen consumption (VO2)
Patients will perform a submaximal incremental exercise on a cycle ergometer. Exercise will start at 20 W and 30 W for females and males, respectively. After 2 minutes at this load, and every 2 minutes thereafter, work rate will increase by 10 W and 15 W for females and males, respectively. Total exercise duration is expected to be within 8 to 14 minutes.
carbon dioxide production (VCO2) (L/min)
Patients will perform a submaximal incremental exercise on a cycle ergometer. Exercise will start at 20 W and 30 W for females and males, respectively. After 2 minutes at this load, and every 2 minutes thereafter, work rate will increase by 10 W and 15 W for females and males, respectively. Total exercise duration is expected to be within 8 to 14 minutes.
respiratory quotient (QR)
Patients will perform a submaximal incremental exercise on a cycle ergometer. Exercise will start at 20 W and 30 W for females and males, respectively. After 2 minutes at this load, and every 2 minutes thereafter, work rate will increase by 10 W and 15 W for females and males, respectively. Total exercise duration is expected to be within 8 to 14 minutes.
Heart Rate (HR) (min-1)
Patients will perform a submaximal incremental exercise on a cycle ergometer. Exercise will start at 20 W and 30 W for females and males, respectively. After 2 minutes at this load, and every 2 minutes thereafter, work rate will increase by 10 W and 15 W for females and males, respectively. Total exercise duration is expected to be within 8 to 14 minutes.
lactate level (mmol/l) at the end of submaximal incremental exercise
Patients will perform a submaximal incremental exercise on a cycle ergometer. Exercise will start at 20 W and 30 W for females and males, respectively. After 2 minutes at this load, and every 2 minutes thereafter, work rate will increase by 10 W and 15 W for females and males, respectively. Total exercise duration is expected to be within 8 to 14 minutes.
Pulmonary volumes (L)
The volumes are measured by plethysmography
Performance to the six minute walk test (m)
Index of muscular blood flow and tissular oxygenation at rest (%)
Patients will perform a submaximal incremental exercise on a cycle ergometer. Exercise will start at 20 W and 30 W for females and males, respectively. After 2 minutes at this load, and every 2 minutes thereafter, work rate will increase by 10 W and 15 W for females and males, respectively. Total exercise duration is expected to be within 8 to 14 minutes.
Index of exercise using Near-infrared reflectance spectroscopy (NIRS) (%)
Patients will perform a submaximal incremental exercise on a cycle ergometer. Exercise will start at 20 W and 30 W for females and males, respectively. After 2 minutes at this load, and every 2 minutes thereafter, work rate will increase by 10 W and 15 W for females and males, respectively. Total exercise duration is expected to be within 8 to 14 minutes.
Maximal voluntary contraction (N)
Maximal Voluntary Contraction (MVC) will be measured 3 times 1 min apart to determine an initial MVC. After 10 min of rest following the MVC trials, neuromuscular fatigability will be assess by repetition of series of 10 submaximal contractions (of 4 s separated by 5 s) followed by a MVC trial until a decrease of 25% of the initial MVC is observed. No more than 7 series will be performed, even if the 25% decrease of initial MVC is not observed.
Neuromuscular fatigability (%)
It is measured in the same time that MVC
Quality of life : Scores to the Short Form 36 (SF-36)
Quality of life : Functional Assessment of Cancer Therapy (FACT Fatigue Part)
Quality of life : State-Trait Anxiety Scale (STAI Y-A)
Quality of life : Physical Self-Description Questionnaire( PSDQ)
Complete blood count and biochemical analyses (ionogram, urea, creatinine, LDH, creatine phosphokinase (CPK), aspartate aminotransferase ; usual units)
Patients will be subjected to blood samplings
Blood and plasma viscosity (centipoise)
Patients will be subjected to blood samplings
Erythrocyte deformability (%)
Patients will be subjected to blood samplings
aggregation properties (a.u.)
Patients will be subjected to blood samplings
dense red blood cells (%)
Patients will be subjected to blood samplings
Plasma analyses of adhesion molecules and markers of inflammation
Patients will be subjected to blood samplings
oxidative stress
Patients will be subjected to blood samplings
NO metabolism (µmol/L)
Patients will be subjected to blood samplings
Activity of antioxidant enzymes (µmol/L/min)
Patients will be subjected to blood samplings
Expression of erythrocytes membrane proteins (u.a.)
Patients will be subjected to blood samplings
Red blood cell (RBC) adhesion to endothelial cells (count of adhering RBC /mm²)
Patients will be subjected to blood samplings
Various hemodynamic criteria using echocardiography at rest and exercise
vaso-occlusive crises and acute chest syndrome
During the 8 weeks, all vaso-occlusive crises and acute chest syndrome will be collected

Full Information

First Posted
August 25, 2015
Last Updated
September 6, 2021
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Centre de Référence des Syndromes Drépanocytaires Majeurs, Laboratoire de Physiologie de l'Exercice, Claude Bernard University
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1. Study Identification

Unique Protocol Identification Number
NCT02571088
Brief Title
Evaluation of a Training Program for Homozygous Sickle Cell Disease Patients
Acronym
EXDRE
Official Title
Evaluation of a Training Program for Homozygous Sickle Cell Disease Patients: Benefits on Physical Ability and Skeletal Muscle. An Interventional Pilot, Multicentric, Prospective, Longitudinal Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Centre de Référence des Syndromes Drépanocytaires Majeurs, Laboratoire de Physiologie de l'Exercice, Claude Bernard University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Besides, endurance training is known to induce moderate muscle hypertrophy and increase microvascular network. Therefore, adapted, moderate and regular physical activity appears as a potential strategy able to improve muscle function, decrease symptoms of the disease and improve autonomy and quality of life of patients with SCD. However, it remains necessary to define the modalities of exercise therapy in SCD and to objectively evaluate the risks, limitations and gains on physical ability, muscle function and quality of life in patients with SCD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Hemoglobin C Disease, Hemoglobin S Disease
Keywords
Sickle Cell Hemoglobin C Disease, Sports Training, Hemoglobin S Disease, Lactate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training Program
Arm Type
Experimental
Arm Description
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.
Arm Title
No Training Program
Arm Type
No Intervention
Arm Description
It will be asked to the control patients to not change their habitual physical activity during the entire period of observation
Intervention Type
Other
Intervention Name(s)
Training Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Power output (W) associated with the 4 mmol/L blood lactate concentration
Description
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Muscle fiber types distribution (%)
Description
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Time Frame
8 weeks
Title
perimeter (µm) of muscle fiber
Description
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Time Frame
8 weeks
Title
surface area (µm2) of muscle fiber
Description
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Time Frame
8 weeks
Title
satellite cell account
Description
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Time Frame
8 weeks
Title
Creatine Kinase (CK) of muscle
Description
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Time Frame
8 weeks
Title
Phosphofructokinase (PFK) of muscle
Description
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Time Frame
8 weeks
Title
Citrate Synthetase (CS) of muscle
Description
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Time Frame
8 weeks
Title
HAD (µmol/min/g dry muscle) of muscle
Description
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Time Frame
8 weeks
Title
COx (arbitrary unit, a.u.) of muscle
Description
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Time Frame
8 weeks
Title
Lactate Dehydrogenase (LDH) of muscle
Description
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Time Frame
8 weeks
Title
isoforms (%) of muscle
Description
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Time Frame
8 weeks
Title
Number of capillaries per mm2 (capillary density) and in contact with a muscle fiber
Description
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Time Frame
8 weeks
Title
surface area of microvessels (µm2)
Description
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Time Frame
8 weeks
Title
diameter of microvessels (µm)
Description
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Time Frame
8 weeks
Title
capillary tortuosity (quotient)
Description
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Time Frame
8 weeks
Title
expired volume (VE)
Description
Patients will perform a submaximal incremental exercise on a cycle ergometer. Exercise will start at 20 W and 30 W for females and males, respectively. After 2 minutes at this load, and every 2 minutes thereafter, work rate will increase by 10 W and 15 W for females and males, respectively. Total exercise duration is expected to be within 8 to 14 minutes.
Time Frame
8 weeks
Title
oxygen consumption (VO2)
Description
Patients will perform a submaximal incremental exercise on a cycle ergometer. Exercise will start at 20 W and 30 W for females and males, respectively. After 2 minutes at this load, and every 2 minutes thereafter, work rate will increase by 10 W and 15 W for females and males, respectively. Total exercise duration is expected to be within 8 to 14 minutes.
Time Frame
8 weeks
Title
carbon dioxide production (VCO2) (L/min)
Description
Patients will perform a submaximal incremental exercise on a cycle ergometer. Exercise will start at 20 W and 30 W for females and males, respectively. After 2 minutes at this load, and every 2 minutes thereafter, work rate will increase by 10 W and 15 W for females and males, respectively. Total exercise duration is expected to be within 8 to 14 minutes.
Time Frame
8 weeks
Title
respiratory quotient (QR)
Description
Patients will perform a submaximal incremental exercise on a cycle ergometer. Exercise will start at 20 W and 30 W for females and males, respectively. After 2 minutes at this load, and every 2 minutes thereafter, work rate will increase by 10 W and 15 W for females and males, respectively. Total exercise duration is expected to be within 8 to 14 minutes.
Time Frame
8 weeks
Title
Heart Rate (HR) (min-1)
Description
Patients will perform a submaximal incremental exercise on a cycle ergometer. Exercise will start at 20 W and 30 W for females and males, respectively. After 2 minutes at this load, and every 2 minutes thereafter, work rate will increase by 10 W and 15 W for females and males, respectively. Total exercise duration is expected to be within 8 to 14 minutes.
Time Frame
8 weeks
Title
lactate level (mmol/l) at the end of submaximal incremental exercise
Description
Patients will perform a submaximal incremental exercise on a cycle ergometer. Exercise will start at 20 W and 30 W for females and males, respectively. After 2 minutes at this load, and every 2 minutes thereafter, work rate will increase by 10 W and 15 W for females and males, respectively. Total exercise duration is expected to be within 8 to 14 minutes.
Time Frame
8 weeks
Title
Pulmonary volumes (L)
Description
The volumes are measured by plethysmography
Time Frame
8 weeks
Title
Performance to the six minute walk test (m)
Time Frame
8 weeks
Title
Index of muscular blood flow and tissular oxygenation at rest (%)
Description
Patients will perform a submaximal incremental exercise on a cycle ergometer. Exercise will start at 20 W and 30 W for females and males, respectively. After 2 minutes at this load, and every 2 minutes thereafter, work rate will increase by 10 W and 15 W for females and males, respectively. Total exercise duration is expected to be within 8 to 14 minutes.
Time Frame
8 weeks
Title
Index of exercise using Near-infrared reflectance spectroscopy (NIRS) (%)
Description
Patients will perform a submaximal incremental exercise on a cycle ergometer. Exercise will start at 20 W and 30 W for females and males, respectively. After 2 minutes at this load, and every 2 minutes thereafter, work rate will increase by 10 W and 15 W for females and males, respectively. Total exercise duration is expected to be within 8 to 14 minutes.
Time Frame
8 weeks
Title
Maximal voluntary contraction (N)
Description
Maximal Voluntary Contraction (MVC) will be measured 3 times 1 min apart to determine an initial MVC. After 10 min of rest following the MVC trials, neuromuscular fatigability will be assess by repetition of series of 10 submaximal contractions (of 4 s separated by 5 s) followed by a MVC trial until a decrease of 25% of the initial MVC is observed. No more than 7 series will be performed, even if the 25% decrease of initial MVC is not observed.
Time Frame
8 weeks
Title
Neuromuscular fatigability (%)
Description
It is measured in the same time that MVC
Time Frame
8 weeks
Title
Quality of life : Scores to the Short Form 36 (SF-36)
Time Frame
8 weeks
Title
Quality of life : Functional Assessment of Cancer Therapy (FACT Fatigue Part)
Time Frame
8 weeks
Title
Quality of life : State-Trait Anxiety Scale (STAI Y-A)
Time Frame
8 weeks
Title
Quality of life : Physical Self-Description Questionnaire( PSDQ)
Time Frame
8 weeks
Title
Complete blood count and biochemical analyses (ionogram, urea, creatinine, LDH, creatine phosphokinase (CPK), aspartate aminotransferase ; usual units)
Description
Patients will be subjected to blood samplings
Time Frame
8 weeks
Title
Blood and plasma viscosity (centipoise)
Description
Patients will be subjected to blood samplings
Time Frame
8 weeks
Title
Erythrocyte deformability (%)
Description
Patients will be subjected to blood samplings
Time Frame
8 weeks
Title
aggregation properties (a.u.)
Description
Patients will be subjected to blood samplings
Time Frame
8 weeks
Title
dense red blood cells (%)
Description
Patients will be subjected to blood samplings
Time Frame
8 weeks
Title
Plasma analyses of adhesion molecules and markers of inflammation
Description
Patients will be subjected to blood samplings
Time Frame
8 weeks
Title
oxidative stress
Description
Patients will be subjected to blood samplings
Time Frame
8 weeks
Title
NO metabolism (µmol/L)
Description
Patients will be subjected to blood samplings
Time Frame
8 weeks
Title
Activity of antioxidant enzymes (µmol/L/min)
Description
Patients will be subjected to blood samplings
Time Frame
8 weeks
Title
Expression of erythrocytes membrane proteins (u.a.)
Description
Patients will be subjected to blood samplings
Time Frame
8 weeks
Title
Red blood cell (RBC) adhesion to endothelial cells (count of adhering RBC /mm²)
Description
Patients will be subjected to blood samplings
Time Frame
8 weeks
Title
Various hemodynamic criteria using echocardiography at rest and exercise
Time Frame
8 weeks
Title
vaso-occlusive crises and acute chest syndrome
Description
During the 8 weeks, all vaso-occlusive crises and acute chest syndrome will be collected
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Patients whom adhesion/compliance to the protocol appears uncertain, Patient involved in another clinical trial or within the exclusion period of a previous clinical trial, 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard FEASSON, MD
Organizational Affiliation
CHU de SAINT-ETIENNE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laurent MESSONIER, PhD
Organizational Affiliation
Université de Savoie
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Centre hospitalier sud francilien
City
Corbeil-essonnes
ZIP/Postal Code
91100
Country
France
Facility Name
CHU Henri MONDOR
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU Kremlin-Bicêtre
City
Le Kremlin Bicetre
ZIP/Postal Code
93270
Country
France
Facility Name
Hopital Europeen Georges POMPIDOU
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Centre hospitalier de Saint-Denis
City
Saint-denis
ZIP/Postal Code
93200
Country
France
Facility Name
CHU de SAINT-ETIENNE
City
Saint-etienne
ZIP/Postal Code
42000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32681734
Citation
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.
Results Reference
derived
PubMed Identifier
31742587
Citation
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.
Results Reference
derived
PubMed Identifier
30389037
Citation
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.
Results Reference
derived

Learn more about this trial

Evaluation of a Training Program for Homozygous Sickle Cell Disease Patients

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