Status:
RECRUITING
Evaluation of Physiological and Psychological Factors Involved in Exercise Intolerance in Patients With β-TTD
Lead Sponsor:
Centre Hospitalier Metropole Savoie
Collaborating Sponsors:
Université Savoie Mont Blanc
Laboratoire de Psychologie et NeuroCognition (LPNC), Université Grenoble Alpes
Conditions:
Beta Thalassemia Transfusion Dependent
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- \- 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.
Key Trial Info
Start Date :
September 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT07207577
Start Date
September 4 2025
End Date
October 1 2028
Last Update
October 6 2025
Active Locations (1)
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1
CH Métropole Savoie
Chambéry, France, 73000