NCT07207577 Evaluation of Physiological and Psychological Factors Involved in Exercise Intolerance in Patients With β-TTD
| NCT ID | NCT07207577 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Metropole Savoie |
| Condition | Beta Thalassemia Transfusion Dependent |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-09-04 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2025-09-04 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Laurent MESSONNIER
STUDY CHAIR
Université Savoie Mont Blanc
Frequently Asked Questions
Who can join the NCT07207577 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Beta Thalassemia Transfusion Dependent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07207577 currently recruiting?
Yes, NCT07207577 is actively recruiting participants. Contact the research team at charlene.dupre@ch-metropole-savoie.fr for enrollment information.
Where is the NCT07207577 trial being conducted?
This trial is being conducted at Chambéry, France.
Who is sponsoring the NCT07207577 clinical trial?
NCT07207577 is sponsored by Centre Hospitalier Metropole Savoie. The principal investigator is Laurent MESSONNIER at Université Savoie Mont Blanc. The trial plans to enroll 36 participants.