Exercise capacity in adults with transfusion-dependent beta-thalassemia compared with matched healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares physical ability of adults with transfusion-dependent β-thalassemia to age- and sex-matched healthy control subjects using a standardized battery of tests. Participants complete body composition measures, a maximal incremental exercise test (with lactate threshold determination), vertical jump, vasoreactivity testing, blood sampling, quality-of-life questionnaires, and neuromuscular assessments. The primary outcome is power output at the first lactate threshold during the maximal incremental exercise test, with secondary physiologic and psychological measures used to explore mechanisms of exercise intolerance. All testing is performed in person at the participating hospital and requires prior informed consent and confirmation of eligibility.

Why it matters

Who can join: the full rules

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.

Where it's running

• CH Métropole Savoie
  Chambéry, France Recruiting

Study contacts

• Principal investigator: Pierre FAURIE — CH Metropole Savoie
• Study coordinator: Charlene DUPRE
• Email: charlene.dupre@ch-metropole-savoie.fr
• Phone: +33479965910

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.