Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 17-25 |
| Number of pages | 9 |
| Journal | Amyotrophic Lateral Sclerosis |
| Volume | 12 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jan 2011 |
Bibliographical note
Funding Information:Study funded by the National Institute of Neurological Disorders and Stroke (NINDS) grant (RO1 NS045087); the General Clinical Research Centers at Columbia (RR00645), Vermont (RR00109), Utah (RR00064), Penn State (RR10732, CO6-RR016499) and Kentucky (RR02602); the ALS Hope Foun dation, and the Cynthia Shaw Crispen Endowment. Lan Chi T. Luu provided helpful discussions during the planning phase of the study. The cooperation of the patients and caregivers is gratefully acknowledged. The authors thank Robin A. Conwit and Janice Cordell of NINDS, and the members of the DSMB, for their assistance during the course of the study.
Funding
Study funded by the National Institute of Neurological Disorders and Stroke (NINDS) grant (RO1 NS045087); the General Clinical Research Centers at Columbia (RR00645), Vermont (RR00109), Utah (RR00064), Penn State (RR10732, CO6-RR016499) and Kentucky (RR02602); the ALS Hope Foun dation, and the Cynthia Shaw Crispen Endowment. Lan Chi T. Luu provided helpful discussions during the planning phase of the study. The cooperation of the patients and caregivers is gratefully acknowledged. The authors thank Robin A. Conwit and Janice Cordell of NINDS, and the members of the DSMB, for their assistance during the course of the study.
| Funders | Funder number |
|---|---|
| ALS Hope Foun dation | |
| Cynthia Shaw Crispen Endowment | |
| General Clinical Research Centers at Columbia | RR00645, RR00064, RR00109 |
| University of Kentucky | RR02602 |
| Institute of Neurological Disorders and Stroke National Advisory Neurological Disorders and Stroke Council | RO1 NS045087 |
| Institute of Neurological Disorders and Stroke National Advisory Neurological Disorders and Stroke Council | |
| National Center for Research Resources | M01RR002602 |
| National Center for Research Resources | |
| The Pennsylvania State University | RR10732, CO6-RR016499 |
| The Pennsylvania State University |
Keywords
- Doubly Labeled Water
- NIPPV
- Nutrition
- energy expenditure
- respiratory scales
ASJC Scopus subject areas
- Neurology
- Clinical Neurology