Non-invasive Evaluation of Muscle Oxidative Capacity. Study of Its Relationship With Muscular Endurance and Fatigue in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Muscular endurance of the gastrocnemius muscles
研究概览
简要总结
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system. It is characterized by different progressive forms with periods of flare-ups interspersed with phases of remission. MS manifests clinically with signs of multiple neurological dysfunctions as well as less specific symptoms such as fatigue, the prevalence of which is found to be high in these patients and is independently associated with an alteration in their quality of life.
Recently, a non-invasive method for assessing maximal muscle oxidative capacity (mVO2) using optical measurement of muscle oxygenation (near-infrared spectroscopy, NIRS) has been described. Measuring tissue light absorption from a skin sensor facing a muscle, makes it possible to distinguish tissue concentrations of oxyhemoglobin (HbO2) and hemoglobin (Hb). The difference in absorbance of Hb and HbO2 corresponds to the balance of O2 supply and consumption in tissue capillaries, allowing calculation of a time constant (kNIRS, min-1) reflecting mitochondrial function.
Current literature provides reference values in young healthy subjects and MS patients. This index could therefore constitute a particularly interesting non-invasive indicator of mitochondrial functioning, usable in the clinic.
详细描述
Following an arterial occlusion, the rate of decay of the NIRS signal is only dependent on local O2 consumption. Following an exercise increasing the oxygen consumption of the muscle (isometric contractions for 10 to 15 s), carrying out a series of brief occlusions makes it possible to calculate mVO2 (slope of O2 desaturation at each occlusion). mVO2 decreases exponentially with time, allowing calculation of a time constant (kNIRS, min-1) reflecting mitochondrial function. Furthermore, it has been shown that kNIRS correlates with mitochondrial respiration rate measured in oxygraphy (Ryan et al., 2014).
A few studies have focused on the link between maximal muscular oxidative capacity (mVO2), fatigue and muscular endurance in patients with MS. Furthermore, contradictory results have been reported regarding mVO2 in this population, suggesting in one case a higher mVO2 compared to healthy subjects while others observe the opposite. This results in an imprecise assessment of maximum muscle oxidative capacity (mVO2) in MS patients and its relationship with fatigue and muscular endurance in this population. The investigator therefore propose to carry out a prospective interventional study to analyze the relationship between these different parameters. The investigator's hypothesis is the existence of a positive correlation between mVO2 and muscular endurance, and negative with fatigue. This relationship will also be sought 6 months after participants engagement in regular physical activity. Given the accumulation of functional deficits, this approach is focused on preventive medicine, and with the aim of improving the care of these patients.
The statistical analyzes will be carried out with Stata software (version 15; StataCorp, College Station, Texas, USA), considering a risk of two-sided first type error of 5%.
Continuous variables will be presented in the form of mean and standard deviation, according to the normality of their distribution (Shapiro-Wilk test if necessary). In case of non-normality, they will be presented in the form of median, quartiles and extreme values. Qualitative variables will be expressed in numbers and associated percentages.
Graphical representations will, as much as possible, be associated with these analyses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Multiple Sclerosis (MS) with a diagnosis established by MRI.
- •Patients with a Kurtzke Expanded Disability Status Scale (EDSS) score <
- •Body mass index (BMI) < 30 Kg/m².
- •Thickness of subcutaneous adipose tissue at the calf ≤ 20 mm.
- •MS patients without neurological signs of flare-up since 1 month.
- •MS patients who have not had any treatment modification during the last 2 months.
- •Subjects affiliated to French health care system (for France).
- •Volunteers who have given their written consent.
排除标准
- •Patients suffering from progressive psychiatric pathologies (active psychosis, , etc.) or the presence of another serious unstabilized pathology (decompensated heart failure, progressive terminal cancer, etc.).
- •People with poorly controlled or unstable cardiovascular disease.
- •Major osteoarticular or neurological problems completely preventing the proper performance of the various tests.
- •Persons under guardianship, curatorship, deprived of liberty or safeguarding justice.
- •Pregnant or lactating women.
结局指标
主要结局
Muscular endurance of the gastrocnemius muscles
时间窗: At the beginning of the protocol inclusion day (to) and at 6 months (t1)
Muscular endurance of the gastrocnemius muscles, represented by the number of repetitions measured with the Single-Leg Heel Raise Test.
Maximal muscle oxidative capacity (mVO2)
时间窗: At the beginning of the protocol inclusion day (to) and at 6 months (t1)
Maximal muscle oxidative capacity will be measured by near-infrared spectroscopy (NIRS)
次要结局
- Functional Assessment of Chronic Illness Therapy Fatigue Scale(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- VO2max (maximal oxygen consumption) (mL/Kg/min)(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Threshold power (Watts)(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Thickness of subcutaneous adipose tissue of the gastrocnemius muscles (mm)(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Functional capacity(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Gastrocnemius muscle endurance (number of repetitions and time(sec))(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Body Mass Index (Kg/m²)(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Maximum power (Watts)(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Tiffeneau ratio (%)(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Weight (Kg)(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Height (cm)(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Waist circumference (cm)(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Body composition(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Expanded Disability Status Scale (EDSS)(At the beginning of the protocol inclusion day (to))
- Hip circumference (cm)(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Energy expenditure level (MET/minute/week)(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Maximum heart rate (bpm)(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Forced vital Capacity (L and % of the theoretical value)(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Ventilatory reserve (%)(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Tissue saturation index (kNIRS, min-1)(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Threshold heart rate (bpm)(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))
- Forced Expiratory volume (L and % of the theoretical value)(At the beginning of the protocol inclusion day (to), at 6 months from the inclusion (t1))