EXerCise Introduction To Enhance Performance in Dialysis(EXCITE) (EXCITE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01255969|
Recruitment Status : Completed
First Posted : December 8, 2010
Last Update Posted : August 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Patients on Dialysis (Hemodialysis, Peritoneal Dialysis)||Other: Exercise||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||EXerCise Introduction To Enhance Performance in Dialysis: the EXCITE Study|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||July 2015|
|No Intervention: Control|
Patients in this arm will undergo to personalized exercise program.
Personalized exercise program
- Assessment of Quality of Life (QoL) modification by the KIDNEY DISEASE QUALITY OF LIFE (KDQOL)questionary [ Time Frame: 6 months ]6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.
- Assessment of functional capacity by Six-Minute Walking test and Sit-to-Stand-to-sit test [ Time Frame: 6 months ]6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.
- Evaluation of mortality (all causes and cardiovascular only), non-fatal cardiovascular events, all-causes hospitalizations and dialysis access survival. [ Time Frame: 6 months ]6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.
- All - causes and cardiovascular hospitalizations [ Time Frame: 6 months ]Hospitalizations will be characterized by ICD-9 codes. Six months is the time frame for the primary analysis but the follow-up will continue until 3 years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255969
|Dialysis Units participating to the EXCITE study in Italy|
|Reggio Calabria, Italy|
|Study Director:||Carmine Zoccali, Prof.||CNR-IBIM and Nephrology Unit, Reggio Calabria|