The ALS Nutrition/NIPPV Study: Design, feasibility, and initial results

The ALS Nutrition/NIPPV Study: Design, feasibility, and initial results
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DOI:
10.3109/17482968.2010.515225
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发表时间:
2011-01-01
影响因子:
--
通讯作者:
Kryscio, Richard J.
Kryscio, Richard J.
中科院分区:
其他
文献类型:
--
作者:
Kasarskis, Edward J.;Mendiondo, Marta S.;Kryscio, Richard J.

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我们的目的是调查ALS患者的营养需求,并确定NIPPV早期干预的可行性。受试者被分为两组。在营养组,使用双标签水法在48周内纵向测定每日总能量消耗(TDEE)。在NIPPV组中,NIPPV的FVC分别为80%和50%。在两组中获得了额外的测量结果,以最终制定预测TDEE的方程,并估计早期NIPPV III期研究的样本量。80名受试者加入营养组,73名受试者加入NIPPV组。描述了参与者的基线特征。在疾病进展期间,80名受试者在249项独立检测中可获得TDEE。同时测量其他变量,以便将来建模als特定方程以预测TDEE。在NIPPV组中,计算NIPPV干预标准的进展率(80%或50%预测FVC)。纵向获得其他因素以发展早期呼吸功能不全的指标。这项研究的结果将使我们能够建立方程来预测ALS患者的能量需求,并计划一项NIPPV早期干预研究。
Our objective was to investigate the nutritional requirements in ALS and to determine the feasibility of early intervention with NIPPV. Subjects were enrolled into one of two arms. In the nutrition arm, total daily energy expenditure (TDEE) was determined longitudinally over 48 weeks using the Doubly Labeled Water method. In the NIPPV arm, NIPPV was offered at 80% vs. 50% FVC. Additional measurements were obtained in both arms to ultimately formulate equations to predict TDEE and to estimate sample size for a phase III study of early NIPPV. Eighty subjects were enrolled in the nutrition arm and 73 in the NIPPV arm. Baseline characteristics of the participants are described. TDEE was available for 80 subjects in 249 independent determinations during disease progression. Other variables were measured simultaneously for future modeling of ALS-specific equations to predict TDEE. In the NIPPV arm, rates of progression to the criteria for NIPPV intervention (80% or 50% predicted FVC) were computed. Additional factors were obtained longitudinally to develop indices of early ventilatory insufficiency. The results of this study will allow us to model equations to predict the energy requirements in ALS and to plan a study of early intervention with NIPPV.