Evaluation of Physiological and Psychological Factors Involved in Exercise Intolerance in Patient… (NCT07207577) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Physiological and Psychological Factors Involved in Exercise Intolerance in Patients With β-TTD
France36 participantsStarted 2025-09-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Power at the first lactate threshold (PSL1) collected during the maximal incremental exercise test, compared between the two groups