Beta Thalassemia Transfusion DependentTHALEXNCT07207577
Evaluation of Physiological and Psychological Factors Involved in Exercise Intolerance in Patients With β-TTD
A study testing Maximal incremental exercise test in people with Beta Thalassemia Transfusion Dependent, run by Centre Hospitalier Metropole Savoie at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Beta Thalassemia Transfusion Dependent
- What is being tested?
- Maximal incremental exercise test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2025to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- - 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CH Métropole Savoie
Chambéry, 73000
Charlene DUPRE, +33479965910, charlene.dupre@ch-metropole-savoie.fr
About this study
Official title: Evaluation of Physiological and Psychological Factors Involved in Exercise Intolerance in Patients With Transfusion-dependent β-thalassemia
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
- Being tested
- Maximal incremental exercise test
- Keywords
- physical ability, Beta thalassemia transfusion dependent, control subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal incremental exercise testOther
Participants will perform a symptom-limited maximal incremental exercise test on a cycle ergometer.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | control participant without Beta thalassemia Receives: Other: Maximal incremental exercise test |
| Beta thalassemia transfusion dependent | Experimental | same intervention than control group Receives: Other: Maximal incremental exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days after a transfusion for patient
Secondary outcomes (21)
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).
Measured: 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)
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.
Measured: 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.
Values will be recorder during maximal incremental exercise test. Heart rate and systolic ejection volume values is continuously recorded by bioimpedance measurement.
Measured: 7 days after a transfusion for patients
Comparison of muscle mass values between βTTD patients and control subjects
A body composition measurement will be performed using bioimpedance analysis.
Measured: 7 days after a transfusion for patients
Comparison between βTTD patients and control subjects of first-second expiratory flow values (FEV1, L)
A spirometry test will be performed. After taking a deep breath, the participant will be asked to exhale as quickly as possible into the spirometer.
Measured: 7 days after a transfusion for patients
Comparison between βTTD patients and control subjects of maximum grip strength, jump height and reactive strength index values
Jump height will be evaluate using video analysis.
Measured: 7 days after a transfusion for patients
Compare neuromuscular function between βTTD patients and control subjects
Nerve conduction will be assessed by electroneuromyography (ENMG). Muscle electrical activity will be measured by ENMG following low-intensity electrical stimulation to collect the F wave. This test will measure: nerve conduction velocity, latency between nerve stimulation and response, response amplitude, and response duration.
Measured: 7 days after a transfusion for patients
Compare the level of physical activity between βTTD patients and control subjects
Level of activvity will be assessed with of International Physical Activity Questionnaire
Measured: During inclusion visit, at day 1
Compare anxiety levels between βTTD patients and control subjects.
score to HADS questionnaire
Measured: During second visit, occuring during a transfusion visit and no longer than 3 months after the inclusion.
Comparison between βTTD patients and control subjects of muscle reoxygenation slope values upon removal of arterial occlusion
A vasoreactivity test will then be performed at rest following venous occlusion, in order to measure the ability to reoxygenate the tissue.
Measured: 7 days after a transfusion for patients
Correlation within the βTTD group between physical ability and cardiac iron load, hepatic iron load and EPO
Correlation within the βTTD group between power at lactate threshold 1 (see primary outcome) and cardiac T2* , hepatic iron concentration and EPO level wich will be taken in patient medical file
Measured: 7 days after a transfusion for patients
Correlation within the βTTD group between testosterone (men) or oestrogen (women) levels and muscle mass in kg
data collected in patient medical file
Measured: 7 days after a transfusion for patients
Correlation within the βTTD group between quality of life and physical ability
SF36 questionnaire will be done and scoore will be correlated to power at first lactic threshold
Measured: During second visit, occuring during a transfusion visit and no longer than 3 months after the inclusion.
Assessing the link between perceived fatigue and physical activity levels in βTTD patients
Correlation between the score at FACIT-F questionnaires compared to scores at IPAQ questionnaires
Measured: During second visit, occuring during a transfusion visit and no longer than 3 months after the inclusion.
Assessing the link between physical fitness and fatigue/pain experienced by βTTD patients
Correlation within the βTTD group between power at lactate threshold 1 and FACIT-F and BPI scores (multivariate analysis).
Measured: During second visit, occuring during a transfusion visit and no longer than 3 months after the inclusion.
Assessing the link between microvascular vasoreactivity, inflammation and haemolysis in βTTD patients
Correlation within the βTTD group between the reoxygenation slope and blood concentrations of CRP, LDH, and indirect bilirubin
Measured: 7 days after transfusion for patients
Assessing motivation for physical activity in βTTD patients
Description of the EMAPS score
Measured: During second visit, occuring during a transfusion visit and no longer than 3 months after the inclusion.
Comparison between βTTD patients and control subjects of vital capacity (VC, L)
A spirometry test will be performed. After taking a deep breath, the participant will be asked to exhale as quickly as possible into the spirometer.
Measured: 7 days after a transfusion for patients
Comparison between βTTD patients and control subjects of maximum exercise ventilation (VE, L.min-1)
The ventilation rate will be continuously monitored during CPET. The ventilation rate value corresponding to the time of maximal exercise based on oxygen consumption will be used.
Measured: 7 days after a transfusion for patients
Comparison between βTTD patients and control subjects of maximum grip strength (kg)
Maximum grip strength will be assessed with a hand dynamometer.
Measured: 7 days after a transfusion for patients
Comparison between βTTD patients and control subjects of reactive strength index values
Reactive strength index values will be calculated based on jump height divided by the time to take-off
Measured: 7 days after a transfusion for patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start4 Sep 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Beta Thalassemia Transfusion DependentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Collaborators
- Université Savoie Mont Blanc, Laboratoire de Psychologie et NeuroCognition (LPNC), Université Grenoble Alpes
- Responsible party
- Sponsor
- Investigators
- Laurent MESSONNIER, Study chair, Université Savoie Mont BlancPierre FAURIE, Principal investigator, CH Metropole SavoieMathilde NOGUER, Study chair, Université Savoie Mont Blanc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207577
- Sponsor's protocol ID
- 2025-A00051-48
- Other IDs
- 2025-A00051-48
- Acronym
- THALEX
- Status last verified
- May 2026
- First submitted
- 16 Sep 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Noguer M, Berthon P, Makowski C, Messonnier LA. Impaired physical ability in patients with transfusion-dependent beta-thalassaemia: Can regular physical activity be a countermeasure? Br J Haematol. 2025 Jan;206(1):86-93. doi: 10.1111/bjh.19847. Epub 2024 Nov 19.
PubMed 39562756
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physiological and Psychological Factors Involved in Exercise Intolerance in Patients With Transfusion-dependent β-thalassemia
- ClinicalTrials.gov ID
- NCT07207577
- Acronym / sponsor ID
- THALEX / 2025-A00051-48
- Conditions
- Beta Thalassemia Transfusion Dependent
- Keywords
- physical ability, Beta thalassemia transfusion dependent, control subjects
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Centre Hospitalier Metropole SavoieUniversity, hospital or other
- Collaborators
- Université Savoie Mont Blanc, Laboratoire de Psychologie et NeuroCognition (LPNC), Université Grenoble Alpes
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Maximal incremental exercise testcontrol participant without Beta thalassemia |
| Beta thalassemia transfusion dependent | Experimental | Other: Maximal incremental exercise testsame intervention than control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients aged 18 years or older
- 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.
Key exclusion criteria (9 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maximal incremental exercise testParticipants will perform a symptom-limited maximal incremental exercise test on a cycle ergometer. | Other | Beta thalassemia transfusion dependent, Control group |
Primary outcome
Power at the first lactate threshold (PSL1) collected during the maximal incremental exercise test, compared between the two groups
Time frame: 7 days after a transfusion for patient
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.
21 secondary outcomes
Comparison of power values at lactate threshold 2 between βTTD patients and control subjects.
Time frame: 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)
Time frame: 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.
Time frame: 7 days after a transfusion for patients
Comparison of muscle mass values between βTTD patients and control subjects
Time frame: 7 days after a transfusion for patients
Comparison between βTTD patients and control subjects of first-second expiratory flow values (FEV1, L)
Time frame: 7 days after a transfusion for patients
Comparison between βTTD patients and control subjects of maximum grip strength, jump height and reactive strength index values
Time frame: 7 days after a transfusion for patients
Compare neuromuscular function between βTTD patients and control subjects
Time frame: 7 days after a transfusion for patients
Compare the level of physical activity between βTTD patients and control subjects
Time frame: During inclusion visit, at day 1
Compare anxiety levels between βTTD patients and control subjects.
Time frame: During second visit, occuring during a transfusion visit and no longer than 3 months after the inclusion.
Comparison between βTTD patients and control subjects of muscle reoxygenation slope values upon removal of arterial occlusion
Time frame: 7 days after a transfusion for patients
Correlation within the βTTD group between physical ability and cardiac iron load, hepatic iron load and EPO
Time frame: 7 days after a transfusion for patients
Correlation within the βTTD group between testosterone (men) or oestrogen (women) levels and muscle mass in kg
Time frame: 7 days after a transfusion for patients
Correlation within the βTTD group between quality of life and physical ability
Time frame: During second visit, occuring during a transfusion visit and no longer than 3 months after the inclusion.
Assessing the link between perceived fatigue and physical activity levels in βTTD patients
Time frame: During second visit, occuring during a transfusion visit and no longer than 3 months after the inclusion.
Assessing the link between physical fitness and fatigue/pain experienced by βTTD patients
Time frame: During second visit, occuring during a transfusion visit and no longer than 3 months after the inclusion.
Assessing the link between microvascular vasoreactivity, inflammation and haemolysis in βTTD patients
Time frame: 7 days after transfusion for patients
Assessing motivation for physical activity in βTTD patients
Time frame: During second visit, occuring during a transfusion visit and no longer than 3 months after the inclusion.
Comparison between βTTD patients and control subjects of vital capacity (VC, L)
Time frame: 7 days after a transfusion for patients
Comparison between βTTD patients and control subjects of maximum exercise ventilation (VE, L.min-1)
Time frame: 7 days after a transfusion for patients
Comparison between βTTD patients and control subjects of maximum grip strength (kg)
Time frame: 7 days after a transfusion for patients
Comparison between βTTD patients and control subjects of reactive strength index values
Time frame: 7 days after a transfusion for patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 39562756Noguer M, Berthon P, Makowski C, Messonnier LA. Impaired physical ability in patients with transfusion-dependent beta-thalassaemia: Can regular physical activity be a countermeasure? Br J Haematol. 2025 Jan;206(1):86-93. doi: 10.1111/bjh.19847. Epub 2024 Nov 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurent MESSONNIER study chair
Université Savoie Mont Blanc
Pierre FAURIE principal investigator
CH Metropole Savoie
Mathilde NOGUER study chair
Université Savoie Mont Blanc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maximal incremental exercise test in people with Beta Thalassemia Transfusion Dependent, run by Centre Hospitalier Metropole Savoie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlene DUPRE (+33479965910, charlene.dupre@ch-metropole-savoie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Power at the first lactate threshold (PSL1) collected during the maximal incremental exercise test, compared between the two groups (time frame: 7 days after a transfusion for patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07207577, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.