Emphysema: Physiologic Effects of Nutritional Support
Condition: Emphysema; Lung Diseases; Lung Diseases, Obstructive; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
Study type: Interventional
Phase: Phase 2

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.
    

Detailed 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.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
    

Intervention name(s): enteral nutrition
Intervention type(s): Procedure
Allocation: Randomized