Francesca Mallamaci1,2, Graziella D'Arrigo1, Giovanni Tripepi1, Nicola Lamberti3, Claudia Torino1, Fabio Manfredini3, Carmine Zoccali4,5. 1. Clinical Epidemiology of Renal Diseases and Hypertension Unit, Institute of Clinical Physiology, Reggio Calabria, Italy. 2. Nephrology, Dialysis and Renal Transplantation Unit, Grande Ospedale Metropolitano, Reggio Calabria, Italy. 3. Department of Neuroscience and Rehabilitation, Section of Sport Sciences, University of Ferrara, Ferrara, Italy. 4. Renal Research Institute, New York, New York carmine.zoccali@tin.it. 5. Associazione Ipertensione Nefrologia e Trapianto Renale c/o Nefrologia, Ospedali Riuniti, Reggio Calabria, Italy.
Abstract
BACKGROUND AND OBJECTIVES: In the EXerCise Introduction to Enhance Performance in Dialysis (EXCITE) trial, a simple, personalized 6-month walking exercise program at home during the day off of dialysis improved the functional status and the risk for hospitalization in patients with kidney failure. In this post-trial observational study, we tested whether the same intervention was associated with a lower long-term risk of death or hospitalization (combined end point) during a follow-up extended up to 36 months. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In total, 227 patients (exercise, n=104; control, n=123) completed the 6-month trial and entered the post-trial observational study. Data were analyzed by unadjusted and adjusted Cox regression analyses and Bayesian analysis. RESULTS: In the long-term observation (up to 36 months), 134 events were recorded (eight deaths not preceded by hospitalization and 126 hospitalizations, which were followed by death in 38 cases). The long-term risk for hospitalization or death was 29% lower (hazard ratio, 0.71; 95% confidence interval, 0.50 to 1.00), and in an analysis stratified by adherence to the walking exercise program during the 6-month trial, the subgroup with high adherence (>60% of prescribed sessions) had a 45% lower risk as compared with the control group (hazard ratio, 0.55; 95% confidence interval, 0.35 to 0.87). A Bayesian analysis showed that the posterior probability of a hazard ratio of 0.71 (95% confidence interval, 0.50 to 1.00) for the risk of the composite outcome observed in the post-trial observational study was 93% under the conservative prior and 97% under the optimistic prior. Sensitivity analyses restricted to the risk of hospitalization only or censoring patients at the time of transplantation fully confirmed these findings. CONCLUSIONS: A simple, personalized, home-based, low-intensity exercise program was associated with a lower risk of hospitalization. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: EXerCise Introduction to Enhance Performance in Dialysis (EXCITE), NCT01255969.
BACKGROUND AND OBJECTIVES: In the EXerCise Introduction to Enhance Performance in Dialysis (EXCITE) trial, a simple, personalized 6-month walking exercise program at home during the day off of dialysis improved the functional status and the risk for hospitalization in patients with kidney failure. In this post-trial observational study, we tested whether the same intervention was associated with a lower long-term risk of death or hospitalization (combined end point) during a follow-up extended up to 36 months. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In total, 227 patients (exercise, n=104; control, n=123) completed the 6-month trial and entered the post-trial observational study. Data were analyzed by unadjusted and adjusted Cox regression analyses and Bayesian analysis. RESULTS: In the long-term observation (up to 36 months), 134 events were recorded (eight deaths not preceded by hospitalization and 126 hospitalizations, which were followed by death in 38 cases). The long-term risk for hospitalization or death was 29% lower (hazard ratio, 0.71; 95% confidence interval, 0.50 to 1.00), and in an analysis stratified by adherence to the walking exercise program during the 6-month trial, the subgroup with high adherence (>60% of prescribed sessions) had a 45% lower risk as compared with the control group (hazard ratio, 0.55; 95% confidence interval, 0.35 to 0.87). A Bayesian analysis showed that the posterior probability of a hazard ratio of 0.71 (95% confidence interval, 0.50 to 1.00) for the risk of the composite outcome observed in the post-trial observational study was 93% under the conservative prior and 97% under the optimistic prior. Sensitivity analyses restricted to the risk of hospitalization only or censoring patients at the time of transplantation fully confirmed these findings. CONCLUSIONS: A simple, personalized, home-based, low-intensity exercise program was associated with a lower risk of hospitalization. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: EXerCise Introduction to Enhance Performance in Dialysis (EXCITE), NCT01255969.
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