title: Effects of a six-month intradialytic physical ACTIvity program and adequate NUTritional support on protein-energy wasting, physical functioning and quality of life in chronic hemodialysis patients: ACTINUT study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Protein-energy wasting (PEW) is common in hemodialysis patients and is a powerful predictor of morbidity and mortality. Although much progress has been made in recent years in identifying the causes and pathogenesis of PEW in hemodialysis patients, actual management by nutritional interventions is not always able to correct PEW. Some investigators suggest that physical exercise may increase the anabolic effects of nutritional interventions, and therefore may have a potential to reverse PEW. The aim of this study is to investigate the effect of intra-dialytic progressive exercise training and adequate nutritional supplementation on markers of PEW, functional capacities and quality of life of adult hemodialysis patients.
  
  
  METHODS
  Fifty end-stage renal disease patients undergoing hemodialysis, who meet the diagnostic criteria for PEW, will be randomly allocated into an exercise or control group for 6 months. The exercise consists of a progressive submaximal individualized cycling exertion using an adapted cycle ergometer, during the three weekly dialysis sessions. Biological markers of nutrition (albumin, prealbumin) will be followed monthly and all patients will be assessed for body composition, walk function, muscle strength, postural stability and quality of life at baseline and during the eighth week (t+2), the sixteenth week (t+4) and the twenty-fourth week (t+6) of the 6-month adapted rehabilitation program.
  
  
  CONCLUSIONS
  The successful completion of this current trial may give precious clues in understanding PEW and encourage nephrologists to extend prescription of exercise programs as well as therapeutic and as preventive interventions in this high-risk population.
  
  
  BACKGROUND
  The protocol for this study was registered with the France Clinical Trials Registry NCT01813851.
authors.affiliation: ECHO Nantes, Centre de dialyse Laënnec, 23, rue des Piliers de la Chauvinière, 448000 Saint Herblain, France. dhristea@echo-sante.com.
authors.forename: Justine
authors.initials: J
authors.lastname: Magnard
authors.forename: Thibault
authors.initials: T
authors.lastname: Deschamps
authors.forename: Christophe
authors.initials: C
authors.lastname: Cornu
authors.forename: Anne
authors.initials: A
authors.lastname: Paris
authors.forename: Dan
authors.initials: D
authors.lastname: Hristea
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003131:Combined Modality Therapy / Q000523:psychology / Q000706:statistics & numerical data; D004044:Dietary Proteins / Q000627:therapeutic use*; D005081:Exercise Therapy / Q000523:psychology*; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D008875:Middle Aged; D011502:Protein-Energy Malnutrition / Q000209:etiology / Q000517:prevention & control* / Q000523:psychology*; D011788:Quality of Life / Q000523:psychology*; D006435:Renal Dialysis / Q000009:adverse effects / Q000523:psychology*; D051436:Renal Insufficiency, Chronic / Q000150:complications / Q000628:therapy; D012107:Research Design; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004044:Dietary Proteins