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Recruiting Not applicable

Evaluation of Physiological and Psychological Factors Involved in Exercise Intolerance in Patients With β-TTD

NCT07207577 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-09-04
Last updated
2026-10-07

Condition(s) studied

Beta Thalassemia Transfusion Dependent

Investigational drug(s) / intervention(s)

Maximal incremental exercise test

Maximal incremental exercise test: Participants will perform a symptom-limited maximal incremental exercise test on a cycle ergometer.

Study summary

The goal of this clinical trial is to compare physical ability of patients with transfusion-dependent β-thalassemia to control subjects. The main question it aims to answer is:

is there a difference in power output at first lactate threshold between patients with transfusion-dependent β-thalassemia and control subjects during maximal incremental exercise test.

Participants will have to realise differents exams including measurement of body compposition, maximal incremental exercise test, vertical jump, vasoreactivity test, blood sampling, quality of life questionnaires and neuromuscular assessments.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Patients aged 18 years or older * Patients with transfusion-dependent β-thalassaemia (B0 or B+) * Patients who have undergone blood transfusions at intervals of between 1 and 8 weeks for at least 5 years. * Have given their free and informed written consent after being informed of the purpose of the study, its conduct and its risks. * Be affiliated with a social security scheme. * Not participating in any other interventional studies during the duration of this study Control subjects must meet all of the following criteria to participate in the study: * Subject aged 18 years or older * Matched in age and gender to a βTTD patient included in the study. * Declaring to be free of known acute or chronic pathologies. * Have given their free written consent after being informed of the purpose of the study, its conduct and its risks. * Be affiliated with a social security scheme. * Not participate in any other interventional study during the duration of this study. * Have 'low' or 'moderate' IPAQ results (inactive or slightly active). Exclusion Criteria: * \- Having received a bone marrow transplant. * History of thromboembolic disease. * Hospitalised for cardiac decompensation in the last 12 months. * Lack of use of limbs (amputee, paraplegic, quadriplegic) * Unable to comply with protocol requirements for social, family or other reasons, as determined by the investigator. * Known concomitant medical condition that could affect compliance with the protocol * benefiting of enhanced protection, namely minors, persons deprived of their liberty by judicial or administrative decision, adults under legal protection and, finally, patients in emergency situations. * Unable to give consent. * Pregnant or breastfeeding women.

Primary outcome measure(s)

  • Power at the first lactate threshold (PSL1) collected during the maximal incremental exercise test, compared between the two groups — 7 days after a transfusion for patient
    Participants perform a maximal incremental exercise test on a cycle ergometer. The protocol includes one-minute intervals, with increments and initial power varying according to the subject's age and gender. The exercise continues until the subject is unable to maintain the power imposed by the current level. A drop of blood sample is taken from the earlobe and immediately analyzed to measure blood lactate concentration and determine first lactate threshold.

Trial sites (1)

FacilityCityRegionStatus
CH Métropole Savoie Chambéry France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07207577 on ClinicalTrials.gov ↗ ← All trials in France