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

Evaluation of Physiological and Psychological Factors Involved in Exercise Intolerance in Patients With Transfusion-dependent β-thalassemia

This test will see if adults with transfusion-dependent beta-thalassemia produce less power at the first lactate threshold than matched healthy adults during a maximal incremental exercise test.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Metropole Savoie (other)
• Locations: 1 site (Chambéry)
• Trial ID: NCT07207577 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with transfusion-dependent β-thalassemia (B0 or B+) who have received regular transfusions every 1–8 weeks for at least 5 years, can provide written informed consent, have social security coverage, and are not enrolled in other interventional studies.

Not a fit: People under 18, those who are not transfusion-dependent, those with uncontrolled comorbidities or acute illness, those unable to perform maximal exercise testing safely, or those who cannot attend in-person visits are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the results could help clinicians tailor exercise recommendations and supportive care to improve physical function and quality of life for people with transfusion-dependent β-thalassemia.

How similar studies have performed: Previous research has reported reduced exercise capacity in thalassemia patients, but direct comparisons of power at the first lactate threshold with matched healthy controls using a comprehensive physiological and psychological test battery are relatively limited.

Eligibility criteria

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 this trial is running

Chambéry

• CH Métropole Savoie — Chambéry, France (RECRUITING)

Study contacts

• Principal investigator: Pierre FAURIE — CH Metropole Savoie
• Study coordinator: Charlene DUPRE

Conditions: Beta Thalassemia Transfusion Dependent, physical ability, Beta thalassemia transfusion dependent, control subjects