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EXerCise Introduction To Enhance Performance in Dialysis(EXCITE) (EXCITE)

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ClinicalTrials.gov Identifier: NCT01255969
Recruitment Status : Completed
First Posted : December 8, 2010
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
Carmine Zoccali, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Brief Summary:
To evaluate if a model of intervention based on a low-grade physical program prescribed in the dialysis centre and performed at home can modify the functional capacity and quality of life, reduce the risk of cardiovascular and all-causes mortality, non-fatal cardiovascular events and vascular access failure in dialysis patients.

Condition or disease Intervention/treatment Phase
Patients on Dialysis (Hemodialysis, Peritoneal Dialysis) Other: Exercise Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
Experimental: Exercise
Patients in this arm will undergo to personalized exercise program.
Other: Exercise
Personalized exercise program



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients on dialysis
  • Dialysis vintage>6 mo.
  • Age>18 aa.
  • Signed informed consent
  • Stable clinical conditions

Exclusion Criteria:

-any physical or clinical limitations to deambulation


Information from the National Library of Medicine

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


Locations
Italy
Dialysis Units participating to the EXCITE study in Italy
Reggio Calabria, Italy
Sponsors and Collaborators
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Investigators
Study Director: Carmine Zoccali, Prof. CNR-IBIM and Nephrology Unit, Reggio Calabria

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carmine Zoccali, prof., Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
ClinicalTrials.gov Identifier: NCT01255969     History of Changes
Other Study ID Numbers: EXCITE-001
First Posted: December 8, 2010    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016

Keywords provided by Carmine Zoccali, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy:
Dialysis
Physical exercise
Clinical Trial
Quality of Life
Performance
Fitness
Cardiovascular Mortality
Vascular access