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

Centre Hospitalier Metropole Savoie

Status: Enrolling

Conditions: Beta Thalassemia Transfusion Dependent

Treatments: Other: Maximal incremental exercise test

Study type: Interventional

Funder types: Other

Identifiers

NCT07207577

CHMS25002

2025-A00051-48 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Control group

Other group

Description:

control participant without Beta thalassemia

Treatment:

Other: Maximal incremental exercise test

Beta thalassemia transfusion dependent

Experimental group

Description:

same intervention than control group

Treatment:

Other: Maximal incremental exercise test