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

NCT07207577 | Recruiting

• 2 other identifiers: CHMS250022025-A00051-48
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Beta Thalassemia Transfusion Dependent

Keywords

physical ability; Beta thalassemia transfusion dependent; control subjects

Outcome Measures

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.

  7 days after a transfusion for patient

Secondary Outcomes (21)

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

  7 days after a transfusion for patients

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

  7 days after a transfusion for patients

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

  7 days after a transfusion for patients

• Comparison of muscle mass values between βTTD patients and control subjects

  7 days after a transfusion for patients

• Comparison between βTTD patients and control subjects of first-second expiratory flow values (FEV1, L)

  7 days after a transfusion for patients

Study Arms (2)

Control group

OTHER

control participant without Beta thalassemia

Other: Maximal incremental exercise test

Beta thalassemia transfusion dependent

EXPERIMENTAL

same intervention than control group

Other: Maximal incremental exercise test

Interventions

Maximal incremental exercise test OTHER

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

Beta thalassemia transfusion dependent; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Centre Hospitalier Metropole Savoie: lead
• Université Savoie Mont Blanc: collaborator
• Laboratoire de Psychologie et NeuroCognition (LPNC), Université Grenoble Alpes: collaborator

Study Sites (1)

CH Métropole Savoie

Chambéry, 73000, France

RECRUITING

Related Publications (1)

• Verhamme DT, Arents JC, Postma PW, Crielaard W, Hellingwerf KJ. Glucose-6-phosphate-dependent phosphoryl flow through the Uhp two-component regulatory system. Microbiology (Reading). 2001 Dec;147(Pt 12):3345-52. doi: 10.1099/00221287-147-12-3345.

  PMID: 11739766 BACKGROUND

Study Officials

• Laurent MESSONNIER

  Université Savoie Mont Blanc

  STUDY CHAIR

• Pierre FAURIE

  CH Metropole Savoie

  PRINCIPAL INVESTIGATOR

• Mathilde NOGUER

  Université Savoie Mont Blanc

  STUDY CHAIR

Central Study Contacts

Charlene DUPRE

CONTACT

+33479965910; charlene.dupre@ch-metropole-savoie.fr

Leo BLERVAQUE

CONTACT

+33479965910; leo.blervaque@ch-metropole-savoie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 6, 2025
• Study Start: September 4, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)