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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carmine Zoccali, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
ClinicalTrials.gov Identifier:
NCT01255969
First received: December 7, 2010
Last updated: August 3, 2016
Last verified: August 2016
  Purpose
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 Intervention Phase
Patients on Dialysis (Hemodialysis, Peritoneal Dialysis)
Other: Exercise
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: EXerCise Introduction To Enhance Performance in Dialysis: the EXCITE Study

Resource links provided by NLM:


Further study details as provided by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy:

Primary Outcome Measures:
  • Assessment of Quality of Life (QoL) modification by the KIDNEY DISEASE QUALITY OF LIFE (KDQOL)questionary [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.


Secondary Outcome Measures:
  • Evaluation of mortality (all causes and cardiovascular only), non-fatal cardiovascular events, all-causes hospitalizations and dialysis access survival. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 500
Study Start Date: April 2010
Study Completion Date: July 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: Exercise
Patients in this arm will undergo to personalized exercise program.
Other: Exercise
Personalized exercise program

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: December 7, 2010
Last Updated: August 3, 2016
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on December 09, 2016