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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-04

Study Completion Date

2028-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Beta Thalassemia Transfusion Dependent

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control group

control participant without Beta thalassemia

Group Type OTHER

Maximal incremental exercise test

Intervention Type OTHER

Participants will perform a symptom-limited maximal incremental exercise test on a cycle ergometer.

Beta thalassemia transfusion dependent

same intervention than control group

Group Type EXPERIMENTAL

Maximal incremental exercise test

Intervention Type OTHER

Participants will perform a symptom-limited maximal incremental exercise test on a cycle ergometer.

Interventions

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Maximal incremental exercise test

Participants will perform a symptom-limited maximal incremental exercise test on a cycle ergometer.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes