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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Maximal incremental exercise test

    Other intervention

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

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Control groupOther 1 intervention
Group B: Beta thalassemia transfusion dependentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Power at the first lactate threshold (PSL1) collected during the maximal incremental exercise test, compared between the two groups

Participants perform a maximal incremental exercise test on a cycle ergometer. The protocol includes one-minute intervals, with increments and initial power varying according to the subject's age and gender. The exercise continues until the subject is unable to maintain the power imposed by the current level. A drop of blood sample is taken from the earlobe and immediately analyzed to measure blood lactate concentration and determine first lactate threshold.

Time frame
7 days after a transfusion for patient

Secondary outcomes

1

Comparison of power values at lactate threshold 2 between βTTD patients and control subjects.

During the exercise test, a drop of blood is taken from the earlobe and immediately analyzed to measure blood lactate concentration and determine secondlactate threshold (LT2).

Time frame
7 days after a transfusion for patients
2

Comparison between βTTD patients and control subjects of oxygen consumption efficiency slope values (OUES for Oxygen Uptake Efficiency Slope)

Cardio-pulmonary parameters are measured continuously throughout the maximum incremental exercise test and are used to calculate, among other things, the oxygen uptake efficiency slope (OUES), an indicator of the subject's ability to transport and use oxygen.

Time frame
7 days after a transfusion for patients
3

Comparison between βTTD patients and control subjects of cardiac output values combining heart rate and systolic ejection volume values during maximal exercise.

Values will be recorder during maximal incremental exercise test. Heart rate and systolic ejection volume values is continuously recorded by bioimpedance measurement.

Time frame
7 days after a transfusion for patients
4

Comparison of muscle mass values between βTTD patients and control subjects

A body composition measurement will be performed using bioimpedance analysis.

Time frame
7 days after a transfusion for patients

Other outcomes

Sponsors and contacts

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Centre Hospitalier Metropole Savoie

Lead sponsor

Université Savoie Mont Blanc

Collaborator

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

Collaborator