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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00522-47 | Other Identifier | ID-RCB number |
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Patients with chronic immune thrombocytopenic purpura (ITP) live with an anxiety-inducing risk of haemorrhage that is unpredictable over several months or years.
They also rate fatigue as one of the most frequent (48%) and most severe (73%) disabling symptoms, which contributes to a reduced quality of life [Cooper, 2021].
In this autoimmune disease targeting platelets, fatigue could be mediated by platelet and immunological abnormalities, and/or promoted by psychobehavioural determinants that are poorly understood in this chronic disease.
Since 1980, the World Health Organisation has stated that functional capacity assessments best reflect the impact of chronic diseases on quality of life, with fatigue playing an important role. The association between fatigue and aerobic physical capacity, determined by maximum oxygen consumption (VO2max), has been demonstrated in several pathologies. It is often associated with the vicious circle of deconditioning, where the impact of the disease on cardiac, muscular and respiratory functions is intertwined with inactive or sedentary behaviours.
At the end of this vicious circle, adults have been shown to have an increased cardiovascular risk and a high prevalence of anxiety and depression syndromes.
VO2max measured by cardiopulmonary exercise testing (CPET) is increasingly used in monitoring, as recommended by the French Society of Cardiology [Marcadet, 2018;Marcadet, 2019]. Our team (Amedro et al.) has set up a research programme on aerobic physical capacity and deconditioning to exercise in chronic childhood diseases and has just published the reference values for exercise tests in healthy paediatric populations, enabling the interpretation of VO2max results in sick children [Gavotto,2023].
However, it has been demonstrated that the VO₂ plateau is not predominantly reached in healthy adults and is rarely reached (<25%) in healthy children. [Armstrong, 1996 ; Åstrand, 1952 ; Rowland, 1992].
Thus, the highest oxygen consumption measurement (VO2pic) is often used instead of VO2max to define aerobic capacity. We will therefore use the concepts of VO2max and VO2pic in this study.
The first population studied by our team was children with congenital heart disease, who showed a significant reduction in their VO2max [Amedro, 2018]. Based on these results, a functional rehabilitation programme (QUALIREHAB) was set up and evaluated in a randomised controlled clinical trial [Amedro, 2019] . The data demonstrate its positive impact not only on VO2max, but also on quality of life. Aerobic physical capacity was assessed in chronic paediatric diseases without direct cardiac involvement.
We have also shown that VO2max declines more rapidly over time in children, adolescents and young adults who have survived childhood cancer [Gavotto, 2023] or in children with asthma [Moreau, 2023].
To date, no prospective controlled studies have reported on the level of aerobic physical capacity in children, adolescents and young adults with cITP.
We therefore hypothesise that fatigue in patients monitored for cITP could be correlated with a decrease in their aerobic physical capacity, causing these patients to enter a 'vicious cycle of deconditioning'. If this hypothesis is verified, an exercise rehabilitation programme could have a positive impact on quality of life, physical health and mental health
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ITP group | Experimental | Children, adolescents and young adults aged 8 to 25 followed for ITPc (N=53) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPT-CPET | Other | Patients with ITP will undergo standard care, medical examination, cardiopulmonary exercise test (CPET), muscular strength and physical activity tests, and validated questionnaires of health-related and disease-related quality of life, mental health, and physical activity |
| Measure | Description | Time Frame |
|---|---|---|
| VO2max measured by exercise testing | Values will be standardised using paediatric reference values. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| First ventilatory threshold (SV1) | as a percentage of theoretical VO2max | Day 1 |
| Ventilatory efficiency | VE/VCO2 slope | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
Presence of at least one contraindication to performing an exercise test
Opposition to participation expressed by the parent(s) or legal guardian(s) for minors (<18 years) or by the patient.
Absence of social security
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marion AUDIE, MD | Contact | +330557656465 | +33 | marion.audie@chu-bordeaux.fr |
| Nathalie ALADJIDI, MD | Contact | +33 05 57 82 02 61 | +33 | nathalie.aladjidi@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pascal AMEDRO, MD,PhD | University Hospital, Bordeaux | Study Director |
| Nathalie ALADJIDI, MD | University Hospital, Bordeaux | Study Director |
| Marion AUDIE, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Armand de Villeneuve Hospital - Montpellier University Hospital | Montpellier | France | 34295 | France |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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We aim to compare the cardiopulmonary fitness in children, adolescents, and young adults with chronic ITP to the recently published pediatric reference values [Gavotto, 2023a].
We plan to express the results for the patient population included in this study in z-scores and by direct comparison with our most recent control group in this study (the most recently published) (n=107).
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|
| Maximal power | Day 1 |
| Oxygen pulse | Day 1 |
| Maximum heart rate | Day 1 |
| Respiratory exchange ratio | Day 1 |
| Respiratory reserve | Day 1 |
| Health-related quality of life | PedsQL® | Day 1 |
| Disease-specific quality of life | Kids ITP Tools | Day 1 |
| Muscular force evaluation | Handgrip® | Day 1 |
| Muscular force evaluation | standing long jump | Day 1 |
| Physical activity evaluation | level of physical activity evaluated using an accelerometer | Between Day 1 and Day 7 |
| Physical activity evaluation |
| Day 1 |
| Mental health evaluation |
| Day 1 |
| Fatigue evaluation | Fat-PTI questionnaire | Day 1 |
| University Hospital, Bordeaux |
| Principal Investigator |
| Institut Saint-Pierre | Palavas-les-Flots | France | 34250 | France |
|
| Armand Trousseau Hospital - AP-HP | Paris | France | 75012 | France |
|
| Robert Debré Hospital - APHP | Paris | France | 75019 | France |
|
| Pellegrin Hospital - Bordeaux University Hospital | Talence | France | 33400 | France |
|
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |