Background/Aims: 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.
Fitness for entering a simple exercise program and mortality: A study corollary to the exercise introduction to enhance performance in dialysis (Excite) trial EXCITE working group / R. Baggetta, D. Bolignano, C. Torino, F. Manfredini, F. Aucella, A. Barillà, Y. Battaglia, S. Bertoli, G. Bonanno, P. Castellino, D. Ciurlino, A. Cupisti, G. D'Arrigo, L. De Paola, F. Fabrizi, P. Fatuzzo, G. Fuiano, L. Lombardi, G. Lucisano, P. Messa, R. Rapanà, F. Rapisarda, S. Rastelli, L. Rocca-Rey, C. Summaria, A. Zuccalà, S. Abd Elhafeez, G. Tripepi, L. Catizone, F. Mallamaci, C. Zoccali. - In: KIDNEY & BLOOD PRESSURE RESEARCH. - ISSN 1420-4096. - 39:2-3(2014), pp. 197-204.
|Titolo:||Fitness for entering a simple exercise program and mortality: A study corollary to the exercise introduction to enhance performance in dialysis (Excite) trial EXCITE working group|
|Parole Chiave:||Physical exercise; Mortality; Outcome study; Dialysis; Deambulation|
|Settore Scientifico Disciplinare:||Settore MED/14 - Nefrologia|
|Data di pubblicazione:||2014|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1159/000355797|
|Appare nelle tipologie:||01 - Articolo su periodico|