Sickle CellVO2drépanoNCT05995743
VO2max & HRQoL in Children With Sickle Cell Disease
An observational study of Sickle Cell and Children, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Sickle cell disease is the most common inherited genetic disorder, accounting for 300,000 births worldwide per year. It is caused by an autosomal recessive mutation of the β-globin gene, responsible for an abnormal hemoglobin, the main protein in red blood cells, responsible for transporting oxygen from the lungs to… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Sickle Cell, Children
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2021to 1 Nov 2022
- Phase
- Observational
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Sickle cell children cohort consisted of children with a genetic diagnosis of sickle cell disease (HbS/S or HbS/C), followed at the Department of Pediatrics of Montpellier University Hospital, a tertiary care academic institution in southern France. Healthy children cohort consisted of children referred to a pediatric cardiologist for a nonsevere functional symptom related to exercise (murmur, palpitation, chest pain, and dyspnoea) or for a medical sports certificate. These children needed to have a completely normal check-up, including physical examination, ECG, and echocardiography. Children with any chronic disease, medical condition or medical treatment, and those requiring any further specialized medical consultation were not eligible.
Who may be able to join
- Child from 6 to 17 years old, with a confirmed diagnosis of sickle cell disease (i.e., homozygous HbS/S or heterozygous HbS/C mutations), during their routine follow-up, having performed :
- a hematology consultation : physical examination, blood test
- a cardiology consultation : electrocardiogram, transthoracic echocardiography
- a respiratory plethysmography
- a CPET and to fill in the study questionnaires.
- Child from 6 to 17 years old having performed a cardio-respiratory exercise test for chest pain, dyspnea on exertion, heart murmur and whose results do not find:
Show all 9Show fewer
- Congenital heart disease (normal echocardiography and ECG)
- Respiratory disease (normal FEV1 and FVC)
- Child having performed a maximal cardio-respiratory stress exercise until exhaustion.
Who cannot join
- Parents' refusal to use medical data.
- Healthy children
- Child taking long-term drug treatment
- Child with chronic disease
- Parents' refusal to use medical data.
Trial locations and contacts
1 site in 1 country.
France1 site
Pediatric and Congenital Cardiology Department, Arnaud De Villeneuve University Hospital
Montpellier, Occitanie, 34295
About this study
Official title: Aerobic Physical Fitness and Health-related Quality of Life in Children With Sickle Cell Disease.
Sickle cell disease is the most common inherited genetic disorder, accounting for 300,000 births worldwide per year. It is caused by an autosomal recessive mutation of the β-globin gene, responsible for an abnormal hemoglobin, the main protein in red blood cells, responsible for transporting oxygen from the lungs to the tissues. The abnormal hemoglobin, known as "Sickle" or S, deforms the red blood cell, causing chronic hemolytic anemia, organ damage (heart, spleen, etc.) and vaso-occlusive crises. Therapeutic progress and specialised patient follow-up have considerably improved the vital and functional prognosis of children and adolescents with sickle cell disease. Physical fitness, measured during a cardiorespiratory exercise test (CPET), is used to determine maximal oxygen uptake (VO2max). Patients with sickle cell disease have a multifactorial limitation of exercise tolerance, which may affect their physical fitness. Authors have shown that VO2max is impaired in children and adolescents with sickle cell disease, independently of their baseline hemoglobin level. Yet VO2max is a key determinant of health-related quality of life (HRQoL) in patients being monitored for a chronic disease. In the past, our team has contributed to the assessment of HRQoL in several groups of pediatric patients suffering from chronic disease (congenital heart disease, PAH). To date, the link between impaired physical fitness and HRQoL has not been demonstrated in sickle cell children. The pathophysiological determinants of reduced physical capacity and exercise tolerance in sickle cell patients have also not been fully elucidated. Studying these factors will enable us to propose appropriate treatment in the future, with the aim of improving physical fitness and HRQoL in children and adolescents with sickle cell disease.
Read the detailed description
This prospective case-control study included sickle cell children and healthy controls from 6 to 17 years old. Patients refuse the use of medical data will be excluded.
After description of the study sample, we will first compare the VO2max Z-score between cases and controls. We will correlate the VO2max to PedsQL self- and proxy-related and Ricci and Gagnon scores (use of the coefficient of correlation rhô). Then we will compare others CPET parameters and will determine associated factors of VO2max with others resting data : hematological, respiratory, cardiologic, anthropometric, educational (use of the coefficient of correlation rhô, and multivariate linear regression model).
- Conditions
- Sickle Cell, Children
- Keywords
- Cardiopulmonary exercise test, VO2max, Sickle cell disease, Child, Heath-related quality of life, Cardiopulmonary rehabilitation
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases: Children with sickle cell disease | Children aged 6 to 17 years with a confirmed diagnosis of sickle cell disease (i.e., homozygous HbS/S or heterozygous HbS/C mutations) | |
| Controls: Healthy children referred for a non-severe functional symptom linked to exercise | Children aged 6 to 17 years with a completely normal check-up, including physical examination, ECG, echocardiography, and spirometry. Children with any chronic disease, medical condition, or medical treatment and those requiring any further specialized medical consultation were not eligible. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between aerobic fitness evaluated by VO2max, expressed in Z-score between cases and controls
Measured: 1 day
Secondary outcomes (4)
Correlation between aerobic fitness and quality of life in cases group
To analyze this, we will correlate the VO2max Z-score and the assessment of health-related quality of life (measured by PedQL 4.0).
Measured: 1 day
Correlation between aerobic fitness and physical activity level, in cases group
To analyze this, we will correlate the VO2max Z-score and the assessment of physical activity level (measured by Ricci and Gagnon questionnaire).
Measured: 1 day
Correlation between aerobic fitness and educational level (knowledge about disease), in cases group
To analyze this, we will correlate the VO2max Z-score and the assessment of educational level (local disease knowledge questionnaire).
Measured: 1 day
Correlation between aerobic fitness and VO2max limiting factors in cases group: demographic, genetic mutation, clinical (comorbidities, respiratory function, cardiac function, anemia, CPET data)
To analyze this, we will correlate the VO2max Z-score and demographic data, genetic mutation, spirometry, plethysmography, trans-thoracic echocardiography, hemoglobin level, other CPET data.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start1 Nov 2021
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Sickle CellStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corentin Laurent-Lacroix, Resident, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995743
- Sponsor's protocol ID
- RECHMPL22_0192
- Acronym
- VO2drépano
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piel FB, Steinberg MH, Rees DC. Sickle Cell Disease. N Engl J Med. 2017 Apr 20;376(16):1561-1573. doi: 10.1056/NEJMra1510865. No abstract available.
PubMed 28423290Ferraresi M, Panzieri DL, Leoni S, Cappellini MD, Kattamis A, Motta I. Therapeutic perspective for children and young adults living with thalassemia and sickle cell disease. Eur J Pediatr. 2023 Jun;182(6):2509-2519. doi: 10.1007/s00431-023-04900-w. Epub 2023 Mar 31.
PubMed 36997768Rees DC, Williams TN, Gladwin MT. Sickle-cell disease. Lancet. 2010 Dec 11;376(9757):2018-31. doi: 10.1016/S0140-6736(10)61029-X. Epub 2010 Dec 3.
PubMed 21131035Connes P, Machado R, Hue O, Reid H. Exercise limitation, exercise testing and exercise recommendations in sickle cell anemia. Clin Hemorheol Microcirc. 2011;49(1-4):151-63. doi: 10.3233/CH-2011-1465.
PubMed 22214686Panepinto JA, O'Mahar KM, DeBaun MR, Loberiza FR, Scott JP. Health-related quality of life in children with sickle cell disease: child and parent perception. Br J Haematol. 2005 Aug;130(3):437-44. doi: 10.1111/j.1365-2141.2005.05622.x.
PubMed 16042695Liem RI, Reddy M, Pelligra SA, Savant AP, Fernhall B, Rodeghier M, Thompson AA. Reduced fitness and abnormal cardiopulmonary responses to maximal exercise testing in children and young adults with sickle cell anemia. Physiol Rep. 2015 Apr;3(4):e12338. doi: 10.14814/phy2.12338.
PubMed 25847915Callahan LA, Woods KF, Mensah GA, Ramsey LT, Barbeau P, Gutin B. Cardiopulmonary responses to exercise in women with sickle cell anemia. Am J Respir Crit Care Med. 2002 May 1;165(9):1309-16. doi: 10.1164/rccm.2002036.
PubMed 11991885Woodson RD. Hemoglobin concentration and exercise capacity. Am Rev Respir Dis. 1984 Feb;129(2 Pt 2):S72-5. doi: 10.1164/arrd.1984.129.2P2.S72. No abstract available.
PubMed 6696347Pianosi P, D'Souza SJ, Esseltine DW, Charge TD, Coates AL. Ventilation and gas exchange during exercise in sickle cell anemia. Am Rev Respir Dis. 1991 Feb;143(2):226-30. doi: 10.1164/ajrccm/143.2.226.
PubMed 1990932Klings ES, Wyszynski DF, Nolan VG, Steinberg MH. Abnormal pulmonary function in adults with sickle cell anemia. Am J Respir Crit Care Med. 2006 Jun 1;173(11):1264-9. doi: 10.1164/rccm.200601-125OC. Epub 2006 Mar 23.
PubMed 16556694Olorunyomi OO, Liem RI, Hsu LL. Motivators and Barriers to Physical Activity among Youth with Sickle Cell Disease: Brief Review. Children (Basel). 2022 Apr 17;9(4):572. doi: 10.3390/children9040572.
PubMed 35455616Amedro P, Gavotto A, Guillaumont S, Bertet H, Vincenti M, De La Villeon G, Bredy C, Acar P, Ovaert C, Picot MC, Matecki S. Cardiopulmonary fitness in children with congenital heart diseases versus healthy children. Heart. 2018 Jun;104(12):1026-1036. doi: 10.1136/heartjnl-2017-312339. Epub 2017 Nov 23.
PubMed 29170358American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.
PubMed 12524257Abassi H, Gavotto A, Picot MC, Bertet H, Matecki S, Guillaumont S, Moniotte S, Auquier P, Moreau J, Amedro P. Impaired pulmonary function and its association with clinical outcomes, exercise capacity and quality of life in children with congenital heart disease. Int J Cardiol. 2019 Jun 15;285:86-92. doi: 10.1016/j.ijcard.2019.02.069. Epub 2019 Mar 1.
PubMed 30857849Amedro P, Basquin A, Gressin V, Clerson P, Jais X, Thambo JB, Guerin P, Cohen S, Bonnet D. Health-related quality of life of patients with pulmonary arterial hypertension associated with CHD: the multicentre cross-sectional ACHILLE study. Cardiol Young. 2016 Oct;26(7):1250-9. doi: 10.1017/S1047951116000056. Epub 2016 Mar 16.
PubMed 26980152
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Physical Fitness and Health-related Quality of Life in Children With Sickle Cell Disease.
- ClinicalTrials.gov ID
- NCT05995743
- Acronym / sponsor ID
- VO2drépano / RECHMPL22_0192
- Conditions
- Sickle Cell, Children
- Keywords
- Cardiopulmonary exercise test, VO2max, Sickle cell disease, Child, Heath-related quality of life, Cardiopulmonary rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 16 Aug 2023 (actual)
- 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 is the most common inherited genetic disorder, accounting for 300,000 births worldwide per year. It is caused by an autosomal recessive mutation of the β-globin gene, responsible for an abnormal hemoglobin, the main protein in red blood cells, responsible for transporting oxygen from the lungs to the tissues. The abnormal hemoglobin, known as "Sickle" or S, deforms the red blood cell, causing chronic hemolytic anemia, organ damage (heart, spleen, etc.) and vaso-occlusive crises. Therapeutic progress and specialised patient follow-up have considerably improved the vital and functional prognosis of children and adolescents with sickle cell disease. Physical fitness, measured during a cardiorespiratory exercise test (CPET), is used to determine maximal oxygen uptake (VO2max). Patients with sickle cell disease have a multifactorial limitation of exercise tolerance, which may affect their physical fitness. Authors have shown that VO2max is impaired in children and adolescents with sickle cell disease, independently of their baseline hemoglobin level. Yet VO2max is a key determinant of health-related quality of life (HRQoL) in patients being monitored for a chronic disease. In the past, our team has contributed to the assessment of HRQoL in several groups of pediatric patients suffering from chronic disease (congenital heart disease, PAH). To date, the link between impaired physical fitness and HRQoL has not been demonstrated in sickle cell children. The pathophysiological determinants of reduced physical capacity and exercise tolerance in sickle cell patients have also not been fully elucidated. Studying these factors will enable us to propose appropriate treatment in the future, with the aim of improving physical fitness and HRQoL in children and adolescents with sickle cell disease.
Detailed description
This prospective case-control study included sickle cell children and healthy controls from 6 to 17 years old. Patients refuse the use of medical data will be excluded.
After description of the study sample, we will first compare the VO2max Z-score between cases and controls. We will correlate the VO2max to PedsQL self- and proxy-related and Ricci and Gagnon scores (use of the coefficient of correlation rhô). Then we will compare others CPET parameters and will determine associated factors of VO2max with others resting data : hematological, respiratory, cardiologic, anthropometric, educational (use of the coefficient of correlation rhô, and multivariate linear regression model).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases: Children with sickle cell disease | – | –Children aged 6 to 17 years with a confirmed diagnosis of sickle cell disease (i.e., homozygous HbS/S or heterozygous HbS/C mutations) |
| Controls: Healthy children referred for a non-severe functional symptom linked to exercise | – | –Children aged 6 to 17 years with a completely normal check-up, including physical examination, ECG, echocardiography, and spirometry. Children with any chronic disease, medical condition, or medical treatment and those requiring any further specialized medical consultation were not eligible. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Sickle cell children cohort consisted of children with a genetic diagnosis of sickle cell disease (HbS/S or HbS/C), followed at the Department of Pediatrics of Montpellier University Hospital, a tertiary care academic institution in southern France. Healthy children cohort consisted of children referred to a pediatric cardiologist for a nonsevere functional symptom related to exercise (murmur, palpitation, chest pain, and dyspnoea) or for a medical sports certificate. These children needed to have a completely normal check-up, including physical examination, ECG, and echocardiography. Children with any chronic disease, medical condition or medical treatment, and those requiring any further specialized medical consultation were not eligible.
Key inclusion criteria (9 listed)
- Child from 6 to 17 years old, with a confirmed diagnosis of sickle cell disease (i.e., homozygous HbS/S or heterozygous HbS/C mutations), during their routine follow-up, having performed :
- a hematology consultation : physical examination, blood test
- a cardiology consultation : electrocardiogram, transthoracic echocardiography
- a respiratory plethysmography
- a CPET and to fill in the study questionnaires.
Key exclusion criteria (5 listed)
- Parents' refusal to use medical data.
- Healthy children
- Child taking long-term drug treatment
- Child with chronic disease
- Parents' refusal to use medical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference between aerobic fitness evaluated by VO2max, expressed in Z-score between cases and controls
Time frame: 1 day
4 secondary outcomes
Correlation between aerobic fitness and quality of life in cases group
Time frame: 1 day
Correlation between aerobic fitness and physical activity level, in cases group
Time frame: 1 day
Correlation between aerobic fitness and educational level (knowledge about disease), in cases group
Time frame: 1 day
Correlation between aerobic fitness and VO2max limiting factors in cases group: demographic, genetic mutation, clinical (comorbidities, respiratory function, cardiac function, anemia, CPET data)
Time frame: 1 day
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 21 Aug 2023.
- Background: PubMed 28423290Piel FB, Steinberg MH, Rees DC. Sickle Cell Disease. N Engl J Med. 2017 Apr 20;376(16):1561-1573. doi: 10.1056/NEJMra1510865. No abstract available.
- Background: PubMed 36997768Ferraresi M, Panzieri DL, Leoni S, Cappellini MD, Kattamis A, Motta I. Therapeutic perspective for children and young adults living with thalassemia and sickle cell disease. Eur J Pediatr. 2023 Jun;182(6):2509-2519. doi: 10.1007/s00431-023-04900-w. Epub 2023 Mar 31.
- Background: PubMed 21131035Rees DC, Williams TN, Gladwin MT. Sickle-cell disease. Lancet. 2010 Dec 11;376(9757):2018-31. doi: 10.1016/S0140-6736(10)61029-X. Epub 2010 Dec 3.
- Background: PubMed 22214686Connes P, Machado R, Hue O, Reid H. Exercise limitation, exercise testing and exercise recommendations in sickle cell anemia. Clin Hemorheol Microcirc. 2011;49(1-4):151-63. doi: 10.3233/CH-2011-1465.
- Background: PubMed 16042695Panepinto JA, O'Mahar KM, DeBaun MR, Loberiza FR, Scott JP. Health-related quality of life in children with sickle cell disease: child and parent perception. Br J Haematol. 2005 Aug;130(3):437-44. doi: 10.1111/j.1365-2141.2005.05622.x.
- Background: PubMed 25847915Liem RI, Reddy M, Pelligra SA, Savant AP, Fernhall B, Rodeghier M, Thompson AA. Reduced fitness and abnormal cardiopulmonary responses to maximal exercise testing in children and young adults with sickle cell anemia. Physiol Rep. 2015 Apr;3(4):e12338. doi: 10.14814/phy2.12338.
- Background: PubMed 11991885Callahan LA, Woods KF, Mensah GA, Ramsey LT, Barbeau P, Gutin B. Cardiopulmonary responses to exercise in women with sickle cell anemia. Am J Respir Crit Care Med. 2002 May 1;165(9):1309-16. doi: 10.1164/rccm.2002036.
- Background: PubMed 6696347Woodson RD. Hemoglobin concentration and exercise capacity. Am Rev Respir Dis. 1984 Feb;129(2 Pt 2):S72-5. doi: 10.1164/arrd.1984.129.2P2.S72. No abstract available.
- Background: PubMed 1990932Pianosi P, D'Souza SJ, Esseltine DW, Charge TD, Coates AL. Ventilation and gas exchange during exercise in sickle cell anemia. Am Rev Respir Dis. 1991 Feb;143(2):226-30. doi: 10.1164/ajrccm/143.2.226.
- Background: PubMed 16556694Klings ES, Wyszynski DF, Nolan VG, Steinberg MH. Abnormal pulmonary function in adults with sickle cell anemia. Am J Respir Crit Care Med. 2006 Jun 1;173(11):1264-9. doi: 10.1164/rccm.200601-125OC. Epub 2006 Mar 23.
- Background: PubMed 35455616Olorunyomi OO, Liem RI, Hsu LL. Motivators and Barriers to Physical Activity among Youth with Sickle Cell Disease: Brief Review. Children (Basel). 2022 Apr 17;9(4):572. doi: 10.3390/children9040572.
- Background: PubMed 29170358Amedro P, Gavotto A, Guillaumont S, Bertet H, Vincenti M, De La Villeon G, Bredy C, Acar P, Ovaert C, Picot MC, Matecki S. Cardiopulmonary fitness in children with congenital heart diseases versus healthy children. Heart. 2018 Jun;104(12):1026-1036. doi: 10.1136/heartjnl-2017-312339. Epub 2017 Nov 23.
- Individual participant dataSharing planned: No
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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.
Corentin Laurent-Lacroix, Resident principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell and Children, run by University Hospital, Montpellier at 1 site 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 9 inclusion and 5 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 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Difference between aerobic fitness evaluated by VO2max, expressed in Z-score between cases and controls (time frame: 1 day). 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 NCT05995743, which also lists 25 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 21 Aug 2023.