EXerCise Introduction To Enhance Performance in Dialysis(EXCITE)

Patients on Dialysis (Hemodialysis, Peritoneal Dialysis) Clinical Trial

— EXCITE  

Official title:

EXerCise Introduction To Enhance Performance in Dialysis: the EXCITE Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255969
• Other study ID #: EXCITE-001
• Status: Completed
• Phase: Phase 4
• First received: December 7, 2010
• Last updated: August 3, 2016
• Start date: April 2010
• Est. completion date: July 2015

Study information

• Verified date: August 2016
• Source: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Patients on Dialysis (Hemodialysis, Peritoneal Dialysis)

Intervention

Other:
• Exercise
Personalized exercise program

Locations

Country	Name	City	State
Italy	Dialysis Units participating to the EXCITE study in Italy	Reggio Calabria

Sponsors (1)

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

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Quality of Life (QoL) modification by the KIDNEY DISEASE QUALITY OF LIFE (KDQOL)questionary	6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.	6 months	No
Primary	Assessment of functional capacity by Six-Minute Walking test and Sit-to-Stand-to-sit test	6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.	6 months	No
Secondary	Evaluation of mortality (all causes and cardiovascular only), non-fatal cardiovascular events, all-causes hospitalizations and dialysis access survival.	6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.	6 months	No
Secondary	All - causes and cardiovascular hospitalizations	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	No