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

August 3, 2016 updated by: Carmine Zoccali, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

EXerCise Introduction To Enhance Performance in Dialysis: the EXCITE Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background Dialysis patients show an exceedingly higher risk of death and cardiovascular complications (1). These patients are also characterized by poor physical performance and reduced quality of life. Observational findings in the United States Renal Data System (USRDS) indicated that physical rehabilitation programs after coronary artery bypass are associated with better clinical outcomes in this population (2). However, the hypothesis that physical training in dialysis patients may translate into better physical performance and clinical outcomes has never been tested in large randomized clinical trials. In studies performed so far, physical exercise was proposed during the dialysis session or between two dialysis sessions. These programs imply compliance, organization and cost problems, mainly related with intensification of visit to the dialysis centre. To limit these difficulties, a single easy-to-implement program of physical exercise for dialysis patients, prescribed in the dialysis centre but performed at home, has been recently elaborated and a pilot study has shown that this program improves physical performance in medium term (3).

Purpose This clinical trial tests whether a physical program prescribed in the dialysis centre but performed at home improves the degree of fitness and the quality of life in dialysis patients.

Study population

  • Inclusion Criteria:

    • 500 Patients on dialysis
    • Dialysis vintage>6 months
    • Age>18 years
    • Signed informed consent
    • Stable clinical conditions

  • Exclusion Criteria:

    • physical or clinical limitations to deambulation

Outcomes:

  • Functional capacity : Evaluation of the variation in the distance covered in a pre-determined time with a validated walking test (six minute walking test); Evaluation of the variation in the time needed to complete 5 cycles of the "sit-to-stand-to sit" test.
  • Quality of Life : Score obtained by a validated questionnaire for dialysis patients (Kidney Disease Quality of Life instrument o KDQOL).
  • Fatal and non-fatal events (cardiovascular and all-causes).
  • All-cause hospitalizations.
  • Vascular access survival. The power analysis was performed by calculating the sample size for each clinical outcome contemplated by the study protocol. The overall sample size of the trial is that portended by the calculation demanding the highest individuals numbers (that of the outcome "fatal and non fatal cardiovascular events" in our instance).

In a previous observational study by our group, the incident rate of fatal and non fatal cardiovascular events was at three years 25% (4). We hypothesised that the physical exercise will produce a 10% reduction in the hazard ratio of fatal cardiovascular events (hazard ratio: 0.70) as compared to that of the control group.

References:

  1. Mallamaci F, Tripepi G, Cutrupi S, Malatino LS, Zoccali C. Prognostic value of combined use of biomarkers of inflammation, endothelial dysfunction, and myocardiopathy in patients with ESRD. Kidney Int. 2005 Jun;67(6):2330-7. PMID: 15882276
  2. Kutner NG, Zhang R, Huang Y, Herzog CA. Cardiac rehabilitation and survival of dialysis patients after coronary bypass. J Am Soc Nephrol. 2006 Apr;17(4):1175-80. Epub 2006 Feb 15. PMID: 16481413
  3. Malagoni AM, Catizone L, Mandini S, Soffritti S, Manfredini R, Boari B, Russo G, Basaglia N, Zamboni P, Manfredini F. Acute and long-term effects of an exercise program for dialysis patients prescribed in hospital and performed at home. J Nephrol. 2008 Nov-Dec;21(6):871-8. PMID: 19034871
  4. Zoccali C, Tripepi G, Mallamaci F.Predictors of cardiovascular death in ESRD.Semin Nephrol. 2005 Nov;25(6):358-62

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Reggio Calabria, Italy
        • Dialysis Units participating to the EXCITE study in Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Investigators

  • Study Director: Carmine Zoccali, Prof., CNR-IBIM and Nephrology Unit, Reggio Calabria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

December 7, 2010

First Submitted That Met QC Criteria

December 7, 2010

First Posted (Estimate)

December 8, 2010

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EXCITE-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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