Skip to content

Physical Fitness of Children, Adolescents and Young Adults With Immune Thrombocytopenic Purpura

Physical Fitness of Children, Adolescents and Young Adults With Immune Thrombocytopenic Purpura: a Prospective, Multicentre, Controlled National Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07310342
Acronym
ITP-CPET
Enrollment
53
Registered
2025-12-30
Start date
2025-12-15
Completion date
2026-12-22
Last updated
2025-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Thrombocytopenic Purpura

Keywords

Immune thrombocytopenic purpura (ITP), Fatigue, Deconditioning, functional rehabilitation

Brief 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 \[Cooper, 2021\]. 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

Interventions

OTHERIPT-CPET

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

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
8 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
VO2max measured by exercise testingDay 1Values will be standardised using paediatric reference values.

Secondary

MeasureTime frameDescription
Ventilatory efficiencyDay 1VE/VCO2 slope
Maximal powerDay 1
Oxygen pulseDay 1
Maximum heart rateDay 1
Respiratory exchange ratioDay 1
Respiratory reserveDay 1
First ventilatory threshold (SV1)Day 1as a percentage of theoretical VO2max
Disease-specific quality of lifeDay 1Kids ITP Tools
Muscular force evaluationDay 1Handgrip®
Physical activity evaluationBetween Day 1 and Day 7level of physical activity evaluated using an accelerometer
Mental health evaluationDay 1* Strenghts and difficulties questionnaire * Adolescent Depression Rating Scale * Patient Health Questionnaire (PHQ-9)
Fatigue evaluationDay 1Fat-PTI questionnaire
Health-related quality of lifeDay 1PedsQL®

Countries

France

Contacts

Primary ContactMarion AUDIE, MD
marion.audie@chu-bordeaux.fr+330557656465
Backup ContactNathalie ALADJIDI, MD
nathalie.aladjidi@chu-bordeaux.fr+33 05 57 82 02 61

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026