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Trial NCT00000573

Resource URI: http://static.linkedct.org/resource/trials/NCT00000573
linkedct:brief_title Emphysema: Physiologic Effects of Nutritional Support
linkedct:condition <http://static.linkedct.org/resource/condition/2817>
linkedct:condition <http://static.linkedct.org/resource/condition/4346>
linkedct:condition <http://static.linkedct.org/resource/condition/7483>
linkedct:condition <http://static.linkedct.org/resource/condition/7486>
linkedct:criteria Men and women with uncomplicated stable chronic obstructive pulmonary disease.
linkedct:description BACKGROUND: Chronic obstructive pulmonary disease is a major health problem and a leading cause for hospital admission in the United States. A severe form of chronic obstructive pulmonary disease that is accompanied by weight loss is commonly referred to as pulmonary cachexia. Studies in the 1960s demonstrated associations in chronic obstructive pulmonary disease patients between weight loss, low FEV1, and early mortality. This observation was strengthened by a retrospective analysis of the Intermittent Positive Pressure Breathing Trial data that suggested malnutrition was an independent predictor of outcome in men with chronic obstructive pulmonary disease. The underlying basis relating malnutrition to adverse outcome in chronic obstructive pulmonary disease was unknown, although there was a large body of information indicating that pulmonary cachexia was associated with respiratory muscle atrophy, myofibrillar substrate depletion, and impaired skeletal and respiratory muscle function. The primary question was whether the nutrition-related functional deficits observed in underweight patients could be reversed. The first three years of the study supported a pilot project of oral nutrition therapy in malnourished chronic obstructive pulmonary disease patients. DESIGN NARRATIVE: All subjects underwent intubation during the initial testing interval and subsequently underwent dietary counseling and oral nutritional supplement during a two-month stabilization phase. Subjects who demonstrated adequate weight gain defined as achievement of more than 90 percent of ideal body weight or who were unable to tolerate intubation were eliminated from further investigation. Eligible subjects were randomized to either ENS or to dietary counseling only. Subjects randomized to ENS received enteral supplementation with Osmolite delivered by continuous infusion pump. Feedings were continuous or nocturnal for sixteen weeks in order to deliver a caloric intake of 1.7 times the resting energy value. Following the intervention phase, all subjects were maintained on dietary counseling on a monthly basis with oral nutritional supplements. Outcome variables were measured before and after the stabilization phase, at eight and sixteen weeks during the intervention phase, and at eight and sixteen weeks during the post-intervention phase. The primary outcome variable was muscle strength and its effect on exercise performance, dyspnea, and quality of life. Secondary outcome variables included morbidity and mortality. The grant was extended through November 1995 for data analysis.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 75 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date November 1995
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000573
rdfs:label Trial NCT00000573
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000573
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 211
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000573>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/49427>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date January 1990
linkedct:study_design Educational/Counseling/Training, Randomized
linkedct:study_type Interventional
linkedct:summary To determine if enteral nutrition support (ENS) restores normal body weight and improves muscle strength, exercise performance, sensation of dyspnea, and quality of life in malnourished patients with chronic obstructive pulmonary disease.
rdf:type linkedct:trials
linkedct:verification_date April 2002