NCT07207577招募中不适用
Evaluation of Physiological and Psychological Factors Involved in Exercise Intolerance in Patients With Transfusion-dependent β-thalassemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Power at the first lactate threshold (PSL1) collected during the maximal incremental exercise test, compared between the two groups
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •- 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.
结局指标
主要结局
Power at the first lactate threshold (PSL1) collected during the maximal incremental exercise test, compared between the two groups
时间窗: 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.
次要结局
- 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)
- Comparison between βTTD patients and control subjects of maximum grip strength, jump height and reactive strength index values(7 days after a transfusion for patients)
- Compare neuromuscular function between βTTD patients and control subjects(7 days after a transfusion for patients)
- Compare the level of physical activity between βTTD patients and control subjects(During inclusion visit, at day 1)
- Compare anxiety levels between βTTD patients and control subjects.(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(7 days after a transfusion for patients)
- Correlation within the βTTD group between physical ability and cardiac iron load, hepatic iron load and EPO(7 days after a transfusion for patients)
- Correlation within the βTTD group between testosterone (men) or oestrogen (women) levels and muscle mass in kg(7 days after a transfusion for patients)
- Correlation within the βTTD group between quality of life and physical ability(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(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(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(7 days after transfusion for patients)
- Assessing motivation for physical activity in βTTD patients(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 maximum grip strength (kg)(7 days after a transfusion for patients)
- Comparison between βTTD patients and control subjects of vital capacity (VC, L)(7 days after a transfusion for patients)
- Comparison between βTTD patients and control subjects of maximum exercise ventilation (VE, L.min-1)(7 days after a transfusion for patients)
- Comparison between βTTD patients and control subjects of reactive strength index values(7 days after a transfusion for patients)
研究者
研究点 (2)
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