EXerCise Introduction To Enhance Performance in Dialysis(EXCITE)

This study is ongoing, but not recruiting participants.
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: January 23, 2014
Last verified: January 2014
  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: 3 years ] [ Designated as safety issue: No ]
  • Assessment of functional capacity by Six-Minute Walking test and Sit-to-Stand-to-sit test [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of mortality (all causes and cardiovascular only), non-fatal cardiovascular events, all-causes hospitalizations and dialysis access survival. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • All - causes and cardiovascular hospitalizations [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Hospitalizations will be characterized by ICD-9 codes


Estimated Enrollment: 500
Study Start Date: April 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 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
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
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:
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: January 23, 2014
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 April 17, 2014