Physical Fitness of Children, Adolescents and Young Adults With Immune Thrombocytopenic Purpura (ITP-CPET)

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].

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 Overview

• Status: Not yet recruiting
• Conditions: Immune Thrombocytopenic Purpura
• Intervention / Treatment: Other: IPT-CPET

• Study Type: Interventional
• Enrollment (Estimated): 53
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marion AUDIE, MD; Phone Number: +33 +330557656465; Email: marion.audie@chu-bordeaux.fr
• Study Contact Backup: Name: Nathalie ALADJIDI, MD; Phone Number: +33 +33 05 57 82 02 61; Email: nathalie.aladjidi@chu-bordeaux.fr

Study Locations

• France
  • France
    • Montpellier, France, France, 34295
      • Armand de Villeneuve Hospital - Montpellier University Hospital
      • Contact: Sophie GUILLAUMONT, MD; Phone Number: +33 +33 0467336639; Email: s-guillaumont@chu-montpellier.fr
      • Contact: Éric JEZIORSKI, MD,PhD; Phone Number: +33 +33 0467336603; Email: e-jeziorski@chu-montpellier.fr
    • Palavas-les-Flots, France, France, 34250
      • Institut Saint-Pierre
      • Contact: Sophie GUILLAUMONT, MD; Phone Number: +33 +33 0467077552; Email: guillaumont.s@institut-st-pierre.fr
    • Paris, France, France, 75012
      • Armand Trousseau Hospital - AP-HP
      • Contact: Sébastien HERITIER, MD,PhD; Phone Number: +33 +33 0171738717; Email: sebastien.heritier@aphp.fr
    • Paris, France, France, 75019
      • Robert Debré Hospital - APHP
      • Contact: Christophe DELCLAUX, MD,PhD; Phone Number: +33 +33 0140034190; Email: christophe.delclaux@aphp.fr
      • Contact: Thierry LEBLANC, Md,PhD; Phone Number: +33 +33 0140034185; Email: thierry.leblanc@aphp.fr
    • Talence, France, France, 33400
      • Pellegrin Hospital - Bordeaux University Hospital
      • Contact: Marion AUDIE, MD; Phone Number: +33 +33 0557656465; Email: marion.audie@chu-bordeaux.fr
      • Contact: Nathalie ALADJIDI Nathalie, MD; Phone Number: +33 +33 0557820261; Email: nathalie.aladjidi@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ITP group; Children, adolescents and young adults aged 8 to 25 followed for ITPc (N=53)	Other: IPT-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2max measured by exercise testing	Values will be standardised using paediatric reference values.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First ventilatory threshold (SV1)	as a percentage of theoretical VO2max	Day 1
Ventilatory efficiency	VE/VCO2 slope	Day 1
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	Children and Adolescents Physical Activity and Sedentary Questionnaire; International Physical Activity Questionnaire	Day 1
Mental health evaluation	Strenghts and difficulties questionnaire; Adolescent Depression Rating Scale; Patient Health Questionnaire (PHQ-9)	Day 1
Fatigue evaluation	Fat-PTI questionnaire	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Director: Pascal AMEDRO, MD,PhD, University Hospital, Bordeaux; Study Director: Nathalie ALADJIDI, MD, University Hospital, Bordeaux; Principal Investigator: Marion AUDIE, MD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 22, 2026

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Fatigue; Deconditioning; functional rehabilitation; Immune thrombocytopenic purpura (ITP)
• Additional Relevant MeSH Terms: Cytopenia; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Skin Manifestations; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura, Thrombocytopenic; Purpura; Thrombocytopenia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Fatigue; Purpura, Thrombocytopenic, Idiopathic
• Other Study ID Numbers: CHUBX 2024/20; 2025-A00522-47 (Other Identifier: ID-RCB number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No