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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Metropole Savoie

About this trial

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

Qualifiers

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.

Disqualifiers

- 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)

Trial design

Treatments tested in this trial

  • Maximal incremental exercise test

Treatment groups

36 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Centre Hospitalier Metropole Savoie

Lead sponsor

Université Savoie Mont Blanc

Collaborator

Laboratoire de Psychologie et NeuroCognition (LPNC), Université Grenoble Alpes

Collaborator