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

NCT07310342 | Not Yet Recruiting

• 2 other identifiers: CHUBX 2024/202025-A00522-47
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 5

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

Conditions

Immune Thrombocytopenic Purpura

Keywords

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

Outcome Measures

Primary Outcomes (1)

• VO2max measured by exercise testing

  Values will be standardised using paediatric reference values.

  Day 1

Secondary Outcomes (15)

• First ventilatory threshold (SV1)

  Day 1

• Ventilatory efficiency

  Day 1

• Maximal power

  Day 1

• Oxygen pulse

  Day 1

• Maximum heart rate

  Day 1

Study Arms (1)

ITP group

EXPERIMENTAL

Children, adolescents and young adults aged 8 to 25 followed for ITPc (N=53)

Other: IPT-CPET

Interventions

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

ITP group

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (5)

Armand de Villeneuve Hospital - Montpellier University Hospital

Montpellier, France, 34295, France

Location

Institut Saint-Pierre

Palavas-les-Flots, France, 34250, France

Location

Armand Trousseau Hospital - AP-HP

Paris, France, 75012, France

Location

Robert Debré Hospital - APHP

Paris, France, 75019, France

Location

Pellegrin Hospital - Bordeaux University Hospital

Talence, France, 33400, France

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Fatigue

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Pascal AMEDRO, MD,PhD

  University Hospital, Bordeaux

  STUDY DIRECTOR

• Nathalie ALADJIDI, MD

  University Hospital, Bordeaux

  STUDY DIRECTOR

• Marion AUDIE, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion AUDIE, MD

CONTACT

+330557656465; marion.audie@chu-bordeaux.fr

Nathalie ALADJIDI, MD

CONTACT

+33 05 57 82 02 61; nathalie.aladjidi@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 22, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

FR (5)