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NCT07207577Recruiting

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

Evaluation of Physiological and Psychological Factors Involved in Exercise Intolerance in Patients With Transfusion-dependent β-thalassemia

Source: ClinicalTrials.gov · Last updated 7 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
36 (estimated)
First submitted
16 Sept 2025
Start date
4 Sept 2025
Primary completion date
Oct 2028
Lead sponsor
Centre Hospitalier Metropole Savoie
Diseases
Thalassaemia
NCT number
NCT07207577

What you commit to

  • Study type: Interventional
  • Planned participants: 36
  • From 4 Sept 2025 to the primary completion date, Oct 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • \- Having received a bone marrow transplant.
  • Known concomitant medical condition that could affect compliance with the protocol

Other illness

  • History of thromboembolic disease.
  • Hospitalised for cardiac decompensation in the last 12 months.

Other

  • 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.
  • 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.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
CH Métropole-Savoie
Coordinator of this site? Confirm its status
ChambéryFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.