title: Fitness for entering a simple exercise program and mortality: a study corollary to the exercise introduction to enhance performance in dialysis (EXCITE) trial.
abstract: OBJECTIVE
  In this corollary analysis of the EXCITE study, we looked at possible differences in baseline risk factors and mortality between subjects excluded from the trial because non-eligible (n=216) or because eligible but refusing to participate (n=116).
  
  
  METHODS
  Baseline characteristics and mortality data were recorded. Survival and independent predictors of mortality were assessed by Kaplan-Meier and Cox regression analyses.
  
  
  RESULTS
  The incidence rate of mortality was higher in non-eligible vs. eligible non-randomized patients (21.0 vs. 10.9 deaths/100 persons-year; P<0.001). The crude excess risk of death in non-eligible patients (HR 1.96; 95% CI 1.36 to 2.77; P<0.001) was reduced after adjustment for risk factors which differed in the two cohorts including age, blood pressure, phosphate, CRP, smoking, diabetes, triglycerides, cardiovascular comorbidities and history of neoplasia (HR 1.60; 95% CI 1.10 to 2.35; P=0.017) and almost nullified after including in the same model also information on deambulation impairment (HR 1.16; 95% CI 0.75 to 1.80; P=0.513).
  
  
  CONCLUSIONS
  Deambulation ability mostly explains the difference in survival rate in non-eligible and eligible non-randomized patients in the EXCITE trial. Extending data analyses and outcome reporting also to subjects not taking part in a trial may be helpful to assess the representability of the study population.
authors.affiliation: CNR-IFC, Clinical Epidemiology and Physiopathology of Renal Diseases and Hypertension of Reggio Calabria, Foggia, Italy.
authors.forename: Rossella
authors.initials: R
authors.lastname: Baggetta
authors.forename: Davide
authors.initials: D
authors.lastname: Bolignano
authors.forename: Claudia
authors.initials: C
authors.lastname: Torino
authors.forename: Fabio
authors.initials: F
authors.lastname: Manfredini
authors.forename: Filippo
authors.initials: F
authors.lastname: Aucella
authors.forename: Antonio
authors.initials: A
authors.lastname: Barillà
authors.forename: Yuri
authors.initials: Y
authors.lastname: Battaglia
authors.forename: Silvio
authors.initials: S
authors.lastname: Bertoli
authors.forename: Graziella
authors.initials: G
authors.lastname: Bonanno
authors.forename: Pietro
authors.initials: P
authors.lastname: Castellino
authors.forename: Daniele
authors.initials: D
authors.lastname: Ciurlino
authors.forename: Adamasco
authors.initials: A
authors.lastname: Cupisti
authors.forename: Graziella
authors.initials: G
authors.lastname: D'Arrigo
authors.forename: Luciano
authors.initials: L
authors.lastname: De Paola
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Fabrizi
authors.forename: Pasquale
authors.initials: P
authors.lastname: Fatuzzo
authors.forename: Giorgio
authors.initials: G
authors.lastname: Fuiano
authors.forename: Luigi
authors.initials: L
authors.lastname: Lombardi
authors.forename: Gaetano
authors.initials: G
authors.lastname: Lucisano
authors.forename: Piergiorgio
authors.initials: P
authors.lastname: Messa
authors.forename: Renato
authors.initials: R
authors.lastname: Rapanà
authors.forename: Francesco
authors.initials: F
authors.lastname: Rapisarda
authors.forename: Stefania
authors.initials: S
authors.lastname: Rastelli
authors.forename: Lisa
authors.initials: L
authors.lastname: Rocca-Rey
authors.forename: Chiara
authors.initials: C
authors.lastname: Summaria
authors.forename: Alessandro
authors.initials: A
authors.lastname: Zuccalà
authors.forename: Samar
authors.initials: S
authors.lastname: Abd ElHafeez
authors.forename: Giovanni
authors.initials: G
authors.lastname: Tripepi
authors.forename: Luigi
authors.initials: L
authors.lastname: Catizone
authors.forename: Francesca
authors.initials: F
authors.lastname: Mallamaci
authors.forename: Carmine
authors.initials: C
authors.lastname: Zoccali
mesh_terms: D000368:Aged; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007676:Kidney Failure, Chronic / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010809:Physical Fitness; D006435:Renal Dialysis; D012307:Risk Factors; D016019:Survival Analysis; D016896:Treatment Outcome