Sickle Cell Hemoglobin C DiseaseEXDRENCT02571088
Evaluation of a Training Program for Homozygous Sickle Cell Disease Patients
A study testing Training Program in people with Sickle Cell Hemoglobin C Disease and Hemoglobin S Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Hemoglobin C Disease, Hemoglobin S Disease
- What is being tested?
- Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 9 sitesFrance
- Study dates
- Sep 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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,
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Hopital Avicenne
Bobigny, 93000
Centre hospitalier sud francilien
Corbeil-Essonnes, 91100
CHU Henri MONDOR
Créteil, 94010
CHU Kremlin-Bicêtre
Le Kremlin-Bicêtre, 93270
Hopital Europeen Georges POMPIDOU
Paris, 75015
Hopital Necker
Paris, 75015
Hopital Tenon
Paris, 75020
Centre hospitalier de Saint-Denis
Saint-Denis, 93200
CHU de SAINT-ETIENNE
Saint-Etienne, 42000
About this study
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
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.
Read the 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.
- Being tested
- Training Program
- Keywords
- Sickle Cell Hemoglobin C Disease, Sports Training, Hemoglobin S Disease, Lactate
- Medical subject headings
- Hemoglobin SC Disease, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (44)
Muscle fiber types distribution (%)
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Measured: 8 weeks
perimeter (µm) of muscle fiber
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Measured: 8 weeks
surface area (µm2) of muscle fiber
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Measured: 8 weeks
satellite cell account
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Measured: 8 weeks
Creatine Kinase (CK) of muscle
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Measured: 8 weeks
Phosphofructokinase (PFK) of muscle
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Measured: 8 weeks
Citrate Synthetase (CS) of muscle
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Measured: 8 weeks
HAD (µmol/min/g dry muscle) of muscle
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Measured: 8 weeks
COx (arbitrary unit, a.u.) of muscle
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Measured: 8 weeks
Lactate Dehydrogenase (LDH) of muscle
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Measured: 8 weeks
isoforms (%) of muscle
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Measured: 8 weeks
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).
Measured: 8 weeks
surface area of microvessels (µm2)
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Measured: 8 weeks
diameter of microvessels (µm)
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Measured: 8 weeks
capillary tortuosity (quotient)
Patients will be subjected to a biopsy of the vastus lateralis muscle (≈ 200 mg).
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Pulmonary volumes (L)
The volumes are measured by plethysmography
Measured: 8 weeks
Performance to the six minute walk test (m)
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Neuromuscular fatigability (%)
It is measured in the same time that MVC
Measured: 8 weeks
Quality of life : Scores to the Short Form 36 (SF-36)
Measured: 8 weeks
Quality of life : Functional Assessment of Cancer Therapy (FACT Fatigue Part)
Measured: 8 weeks
Quality of life : State-Trait Anxiety Scale (STAI Y-A)
Measured: 8 weeks
Quality of life : Physical Self-Description Questionnaire( PSDQ)
Measured: 8 weeks
Complete blood count and biochemical analyses (ionogram, urea, creatinine, LDH, creatine phosphokinase (CPK), aspartate aminotransferase ; usual units)
Patients will be subjected to blood samplings
Measured: 8 weeks
Blood and plasma viscosity (centipoise)
Patients will be subjected to blood samplings
Measured: 8 weeks
Erythrocyte deformability (%)
Patients will be subjected to blood samplings
Measured: 8 weeks
aggregation properties (a.u.)
Patients will be subjected to blood samplings
Measured: 8 weeks
dense red blood cells (%)
Patients will be subjected to blood samplings
Measured: 8 weeks
Plasma analyses of adhesion molecules and markers of inflammation
Patients will be subjected to blood samplings
Measured: 8 weeks
oxidative stress
Patients will be subjected to blood samplings
Measured: 8 weeks
NO metabolism (µmol/L)
Patients will be subjected to blood samplings
Measured: 8 weeks
Activity of antioxidant enzymes (µmol/L/min)
Patients will be subjected to blood samplings
Measured: 8 weeks
Expression of erythrocytes membrane proteins (u.a.)
Patients will be subjected to blood samplings
Measured: 8 weeks
Red blood cell (RBC) adhesion to endothelial cells (count of adhering RBC /mm²)
Patients will be subjected to blood samplings
Measured: 8 weeks
Various hemodynamic criteria using echocardiography at rest and exercise
Measured: 8 weeks
vaso-occlusive crises and acute chest syndrome
During the 8 weeks, all vaso-occlusive crises and acute chest syndrome will be collected
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startSep 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell Hemoglobin C DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Référence des Syndromes Drépanocytaires Majeurs, Laboratoire de Physiologie de l'Exercice, Claude Bernard University
- Responsible party
- Sponsor
- Investigators
- Leonard FEASSON, MD, Principal investigator, CHU de SAINT-ETIENNELaurent MESSONIER, PhD, Study director, Université de Savoie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571088
- Sponsor's protocol ID
- 1408030
- Other IDs
- 2014-A00334-43
- Acronym
- EXDRE
- Status last verified
- Sep 2021
- First submitted
- 25 Aug 2015
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32681734Merlet 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.
PubMed 31742587Gellen 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.
PubMed 30389037
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02571088
- Acronym / sponsor ID
- EXDRE / 1408030
- Keywords
- Sickle Cell Hemoglobin C Disease, Sports Training, Hemoglobin S Disease, Lactate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Centre de Référence des Syndromes Drépanocytaires Majeurs, Laboratoire de Physiologie de l'Exercice, Claude Bernard University
- Study start
- Sep 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Program | Experimental | Other: Training ProgramThe 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training ProgramEach 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. | Other | Training Program |
Primary outcome
Power output (W) associated with the 4 mmol/L blood lactate concentration
Time frame: 8 weeks
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
44 secondary outcomes
Muscle fiber types distribution (%)
Time frame: 8 weeks
perimeter (µm) of muscle fiber
Time frame: 8 weeks
surface area (µm2) of muscle fiber
Time frame: 8 weeks
satellite cell account
Time frame: 8 weeks
Creatine Kinase (CK) of muscle
Time frame: 8 weeks
Phosphofructokinase (PFK) of muscle
Time frame: 8 weeks
Citrate Synthetase (CS) of muscle
Time frame: 8 weeks
HAD (µmol/min/g dry muscle) of muscle
Time frame: 8 weeks
COx (arbitrary unit, a.u.) of muscle
Time frame: 8 weeks
Lactate Dehydrogenase (LDH) of muscle
Time frame: 8 weeks
isoforms (%) of muscle
Time frame: 8 weeks
Number of capillaries per mm2 (capillary density) and in contact with a muscle fiber
Time frame: 8 weeks
surface area of microvessels (µm2)
Time frame: 8 weeks
diameter of microvessels (µm)
Time frame: 8 weeks
capillary tortuosity (quotient)
Time frame: 8 weeks
expired volume (VE)
Time frame: 8 weeks
oxygen consumption (VO2)
Time frame: 8 weeks
carbon dioxide production (VCO2) (L/min)
Time frame: 8 weeks
respiratory quotient (QR)
Time frame: 8 weeks
Heart Rate (HR) (min-1)
Time frame: 8 weeks
lactate level (mmol/l) at the end of submaximal incremental exercise
Time frame: 8 weeks
Pulmonary volumes (L)
Time frame: 8 weeks
Performance to the six minute walk test (m)
Time frame: 8 weeks
Index of muscular blood flow and tissular oxygenation at rest (%)
Time frame: 8 weeks
Index of exercise using Near-infrared reflectance spectroscopy (NIRS) (%)
Time frame: 8 weeks
Maximal voluntary contraction (N)
Time frame: 8 weeks
Neuromuscular fatigability (%)
Time frame: 8 weeks
Quality of life : Scores to the Short Form 36 (SF-36)
Time frame: 8 weeks
Quality of life : Functional Assessment of Cancer Therapy (FACT Fatigue Part)
Time frame: 8 weeks
Quality of life : State-Trait Anxiety Scale (STAI Y-A)
Time frame: 8 weeks
Quality of life : Physical Self-Description Questionnaire( PSDQ)
Time frame: 8 weeks
Complete blood count and biochemical analyses (ionogram, urea, creatinine, LDH, creatine phosphokinase (CPK), aspartate aminotransferase ; usual units)
Time frame: 8 weeks
Blood and plasma viscosity (centipoise)
Time frame: 8 weeks
Erythrocyte deformability (%)
Time frame: 8 weeks
aggregation properties (a.u.)
Time frame: 8 weeks
dense red blood cells (%)
Time frame: 8 weeks
Plasma analyses of adhesion molecules and markers of inflammation
Time frame: 8 weeks
oxidative stress
Time frame: 8 weeks
NO metabolism (µmol/L)
Time frame: 8 weeks
Activity of antioxidant enzymes (µmol/L/min)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Derived from this study: PubMed 32681734Merlet 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.
- Derived from this study: PubMed 31742587Merlet 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.
- Derived from this study: PubMed 30389037Gellen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard FEASSON, MD principal investigator
CHU de SAINT-ETIENNE
Laurent MESSONIER, PhD study director
Université de Savoie
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training Program in people with Sickle Cell Hemoglobin C Disease and Hemoglobin S Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Power output (W) associated with the 4 mmol/L blood lactate concentration (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02571088, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.