Immune Thrombocytopenic PurpuraITP-CPETNCT07310342
Physical Fitness of Children, Adolescents and Young Adults With Immune Thrombocytopenic Purpura
A study testing IPT-CPET in people with Immune Thrombocytopenic Purpura, run by University Hospital, Bordeaux at 5 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Immune Thrombocytopenic Purpura
- What is being tested?
- IPT-CPET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 5 sitesFrance
- Study dates
- 15 Dec 2025to 22 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children, adolescents and young adults aged 8 to 25 followed for ITPc
- Patient referred as part of routine care by a CEREVANCE network expert physician to an exercise physiology laboratory for fitness assessment
Who cannot join
- Presence of at least one contraindication to performing an exercise test
- Acute anemia < 9g or poorly tolerated chronic anemia, fever, uncontrolled asthma, respiratory failure, acute myocarditis or pericarditis, uncontrolled arrhythmias causing symptoms or hemodynamic disturbance, uncontrolled heart failure, acute pulmonary embolism or pulmonary infarction,
- Patients with mental impairment leading to an inability to cooperate, as assessed by the physician during the history,
- Clinical examination abnormalities (heart murmur, rhythm disorders).
- Opposition to participation expressed by the parent(s) or legal guardian(s) for minors (<18 years) or by the patient.
- Absence of social security
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites
Armand de Villeneuve Hospital - Montpellier University Hospital
Montpellier, France, 34295
Sophie GUILLAUMONT, MD, +33 0467336639 ext. +33, s-guillaumont@chu-montpellier.fr
Éric JEZIORSKI, MD,PhD, +33 0467336603 ext. +33, e-jeziorski@chu-montpellier.fr
Institut Saint-Pierre
Palavas-les-Flots, France, 34250
Sophie GUILLAUMONT, MD, +33 0467077552 ext. +33, guillaumont.s@institut-st-pierre.fr
Armand Trousseau Hospital - AP-HP
Paris, France, 75012
Sébastien HERITIER, MD,PhD, +33 0171738717 ext. +33, sebastien.heritier@aphp.fr
Robert Debré Hospital - APHP
Paris, France, 75019
Christophe DELCLAUX, MD,PhD, +33 0140034190 ext. +33, christophe.delclaux@aphp.fr
Thierry LEBLANC, Md,PhD, +33 0140034185 ext. +33, thierry.leblanc@aphp.fr
Pellegrin Hospital - Bordeaux University Hospital
Talence, France, 33400
Marion AUDIE, MD, +33 0557656465 ext. +33, marion.audie@chu-bordeaux.fr
Nathalie ALADJIDI Nathalie, MD, +33 0557820261 ext. +33, nathalie.aladjidi@chu-bordeaux.fr
About this study
Official title: Physical Fitness of Children, Adolescents and Young Adults With Immune Thrombocytopenic Purpura: a Prospective, Multicentre, Controlled National Study
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].
Read more
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
- Conditions
- Immune Thrombocytopenic Purpura
- Being tested
- IPT-CPET
- Keywords
- Immune thrombocytopenic purpura (ITP), Fatigue, Deconditioning, functional rehabilitation
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPT-CPETOther
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
| Study group | Role | What they receive |
|---|---|---|
| ITP group | Experimental | Children, adolescents and young adults aged 8 to 25 followed for ITPc (N=53) Receives: Other: IPT-CPET |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max measured by exercise testing
Values will be standardised using paediatric reference values.
Measured: Day 1
Secondary outcomes (15)
First ventilatory threshold (SV1)
as a percentage of theoretical VO2max
Measured: Day 1
Ventilatory efficiency
VE/VCO2 slope
Measured: Day 1
Maximal power
Measured: Day 1
Oxygen pulse
Measured: Day 1
Maximum heart rate
Measured: Day 1
Respiratory exchange ratio
Measured: Day 1
Respiratory reserve
Measured: Day 1
Health-related quality of life
PedsQL®
Measured: Day 1
Disease-specific quality of life
Kids ITP Tools
Measured: Day 1
Muscular force evaluation
Handgrip®
Measured: Day 1
Muscular force evaluation
standing long jump
Measured: Day 1
Physical activity evaluation
level of physical activity evaluated using an accelerometer
Measured: Between Day 1 and Day 7
Physical activity evaluation
- Children and Adolescents Physical Activity and Sedentary Questionnaire
- International Physical Activity Questionnaire
Measured: Day 1
Mental health evaluation
- Strenghts and difficulties questionnaire
- Adolescent Depression Rating Scale
- Patient Health Questionnaire (PHQ-9)
Measured: Day 1
Fatigue evaluation
Fat-PTI questionnaire
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion22 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal AMEDRO, MD,PhD, Study director, University Hospital, BordeauxNathalie ALADJIDI, MD, Study director, University Hospital, BordeauxMarion AUDIE, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310342
- Sponsor's protocol ID
- CHUBX 2024/20
- Other IDs
- 2025-A00522-47
- Acronym
- ITP-CPET
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Fitness of Children, Adolescents and Young Adults With Immune Thrombocytopenic Purpura: a Prospective, Multicentre, Controlled National Study
- ClinicalTrials.gov ID
- NCT07310342
- Acronym / sponsor ID
- ITP-CPET / CHUBX 2024/20
- Conditions
- Immune Thrombocytopenic Purpura
- Keywords
- Immune thrombocytopenic purpura (ITP), Fatigue, Deconditioning, functional rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 22 Dec 2026 (estimated)
- First posted
- 30 Dec 2025 (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.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| ITP group | Experimental | Other: IPT-CPETChildren, adolescents and young adults aged 8 to 25 followed for ITPc (N=53) |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children, adolescents and young adults aged 8 to 25 followed for ITPc
- Patient referred as part of routine care by a CEREVANCE network expert physician to an exercise physiology laboratory for fitness assessment
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| IPT-CPETPatients 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 | Other | ITP group |
Primary outcome
VO2max measured by exercise testing
Time frame: Day 1
Values will be standardised using paediatric reference values.
15 secondary outcomes
First ventilatory threshold (SV1)
Time frame: Day 1
Ventilatory efficiency
Time frame: Day 1
Maximal power
Time frame: Day 1
Oxygen pulse
Time frame: Day 1
Maximum heart rate
Time frame: Day 1
Respiratory exchange ratio
Time frame: Day 1
Respiratory reserve
Time frame: Day 1
Health-related quality of life
Time frame: Day 1
Disease-specific quality of life
Time frame: Day 1
Muscular force evaluation
Time frame: Day 1
Muscular force evaluation
Time frame: Day 1
Physical activity evaluation
Time frame: Between Day 1 and Day 7
Physical activity evaluation
Time frame: Day 1
Mental health evaluation
Time frame: Day 1
Fatigue evaluation
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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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.
Pascal AMEDRO, MD,PhD study director
University Hospital, Bordeaux
Nathalie ALADJIDI, MD study director
University Hospital, Bordeaux
Marion AUDIE, MD principal investigator
University Hospital, Bordeaux
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPT-CPET in people with Immune Thrombocytopenic Purpura, run by University Hospital, Bordeaux at 5 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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marion AUDIE, MD (+330557656465 ext. +33, marion.audie@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2max measured by exercise testing (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2025.