Actively Recruiting
Evaluation of Physiological and Psychological Factors Involved in Exercise Intolerance in Patients With β-TTD
Led by Centre Hospitalier Metropole Savoie · Updated on 2025-10-06
36
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Metropole Savoie
Lead Sponsor
U
Université Savoie Mont Blanc
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Evaluation of Physiological and Psychological Factors Involved in Exercise Intolerance in Patients With β-TTD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Patients with transfusion-dependent beta-thalassemia (B0 or B+)
- Patients who have undergone blood transfusions at intervals of 1 to 8 weeks for at least 5 years
- Have given free and informed written consent after being informed of the study purpose, conduct, and risks
- Be affiliated with a social security scheme
- Not participating in any other interventional studies during this study
- Control subjects must be aged 18 years or older
- Control subjects matched in age and gender to a beta-thalassemia patient in the study
- Control subjects must declare being free of known acute or chronic diseases
- Control subjects have given free written consent after being informed of the study purpose, conduct, and risks
- Control subjects must be affiliated with a social security scheme
- Control subjects must not participate in other interventional studies during this study
- Control subjects must have 'low' or 'moderate' physical activity levels (inactive or slightly active)
You will not qualify if you...
- Having received a bone marrow transplant
- History of thromboembolic disease
- Hospitalized 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 medical conditions that could affect compliance with the protocol
- Being a minor, deprived of liberty by judicial or administrative decision, under legal protection, or in emergency situations
- Unable to give consent
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 1 location
1
CH Métropole Savoie
Chambéry, France, 73000
Actively Recruiting
Research Team
C
Charlene DUPRE
CONTACT
L
Leo BLERVAQUE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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